Download PDF

Clinical Trial Results:
A Phase 3 Master Protocol to Evaluate Additional Dose(s) Of BNT162b2 In Healthy Individuals Previously Vaccinated With BNT162b2

Summary
EudraCT number	2021-005197-25
Trial protocol	DE
Global end of trial date	25 May 2023
Results information
Results version number	v3(current)
This version publication date	09 Dec 2023
First version publication date	18 May 2023
Other versions	v1 , v2
Version creation reason

Trial information Top of page
Trial identification
Sponsor protocol code	C4591031
Additional study identifiers
ISRCTN number	-
US NCT number	NCT04955626
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	BioNTech SE
Sponsor organisation address	An der Goldgrube 12, Mainz, Germany, 55131
Public contact	BioNTech SE, BioNTech clinical trials patient information, +49 6131 90840, patients@biontech.de
Scientific contact	BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	Yes
Results analysis stage
Analysis stage	Interim
Date of interim/final analysis	01 Sep 2022
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	25 May 2023
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	SSA:Efficacy of booster dose(BD) of BNT162b2(BNT) against confirmed COVID-19.Safety profile of BD of BNT. SSB:Frequency of elevated troponin I levels before and after BD of BNT/placebo.Safety profile of BD of BNT. SSC:Safety profile and immune response of BD of BNT(10mcg/30mcg)given as 3rd dose in subjects(sub) 12-17 years(Y). SSD:Safety and tolerability and immune response of BNT OMI and BNT given as 3rd, 4th or 5th dose or 3rd of 4th dose respectively to BNT-experienced(exp) sub or as 2 -dose series to COVID-19 vaccine-naïve sub. SSE:Safety,tolerability, and immune response of BNT,BNT OMI, bivalent BNT/BNT OMI given as 4th dose(30mcg/60mcg)to BNT-exp sub >55 Y;BNT OMI 60mcg and bivalent BNT/BNT OMI(30mcg/60mcg) given as 4th dose to BNT-exp sub 18-55 Y. SSF:Safety,tolerability, and immune response of BNT,BNT OMI and combination of BNT/BNT OMI given as 4th dose(30 mcg/60 mcg)in BNT-exp sub. BNT162b2 OMI evaluated in SSD, SSE, SSF encodes S protein for the Omicron BA.1 sublineage.
Protection of trial subjects	The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	01 Jul 2021
Long term follow-up planned	Yes
Long term follow-up rationale	Safety, Efficacy
Long term follow-up duration	23 Months
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Brazil: 1164
Country: Number of subjects enrolled	South Africa: 1235
Country: Number of subjects enrolled	United States: 13775
Country: Number of subjects enrolled	Germany: 51
Country: Number of subjects enrolled	Israel: 122
Worldwide total number of subjects	16347
EEA total number of subjects	51
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	691
Adults (18-64 years)	11989
From 65 to 84 years	3633
85 years and over	34

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	SSA: 10137 subjects enrolled,10125 vaccinated,4 multiple enrolled. 10121 evaluated. SSB: 1487 subjects randomised,1485 vaccinated and evaluated. SSC: 140 subjects randomised, vaccinated, and evaluated. SSD: 1465 subjects vaccinated and evaluated. SSE: 3010 subjects vaccinated and evaluated. SSF: 123 subjects randomised,122 vaccinated and evaluated.
Period 1
Period 1 title	Overall Period
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Investigator, Carer, Subject
Arms
Are arms mutually exclusive	Yes
Arm title	SSA: BNT162b2 30 mcg: Blinded and Open Label Period
Arm description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSA: Placebo: Blinded Period
Arm description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Normal saline solution of 0.9 percent [%] sodium chloride
Arm title	SSB: BNT162b2 30 mcg then Placebo
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSB: Placebo then BNT162b2 30 mcg
Arm description	Subjects received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
Arm type	Experimental
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Normal saline solution of 0.9 percent [%] sodium chloride
Arm title	SSC: BNT162b2 10 mcg
Arm description	Subjects received one dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	10 microgram administered intramuscularly
Arm title	SSC:BNT162b2 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSD: Cohort 1: Group 1
Arm description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSD: Cohort 1: Group 2
Arm description	Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSD: Cohort 1: Group 2b
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSD: Cohort 2: Group 3
Arm description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSD: Cohort 2: Group 4
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSD: Cohort 3: Group 5
Arm description	Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Subjects upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
Arm description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Arm description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Arm description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Arm description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Arm description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Arm description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Arm description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Arm description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSF: BNT162b2 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSF: BNT162b2 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSF: BNT162b2 OMI 30 mcg
Arm description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSF: BNT162b2 OMI 60 mcg
Arm description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2 OMI
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Arm title	SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Arm description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Arm description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Bivalent BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	60 microgram administered intramuscularly
Number of subjects in period 1 [1] SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg SSD: Cohort 1: Group 1 SSD: Cohort 1: Group 2 SSD: Cohort 1: Group 2b SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 SSD: Cohort 3: Group 5 SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Started 5080 5041 753 732 75 65 216 197 204 315 323 210 30 30 30 482 159 321 20 20 20 20 20 20 305 302 307 307 304 313 21 19 21 20 20 21 Completed 421 22 726 693 69 58 197 183 193 286 293 159 28 30 27 450 151 302 19 19 19 19 20 19 292 294 291 299 294 307 21 19 21 20 20 21 Not completed 4659 5019 27 39 6 7 19 14 11 29 30 51 2 0 3 32 8 19 1 1 1 1 0 1 13 8 16 8 10 6 0 0 0 0 0 0      Adverse event, serious fatal - 2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -      Consent withdrawn by subject 26 62 14 16 1 2 9 5 3 15 11 7 2 - 1 11 2 5 - - 1 - - - 5 1 5 1 4 2 - - - - - -      Physician decision 1 1 - 3 - - 1 1 - - - 5 - - - - - - - - - - - - - - - - - - - - - - - -      No longer meets eligibility criteria 1 2 - 1 - - - - 1 - 1 1 - - - 3 - 2 - - - - - - 1 - - 1 - - - - - - - -      Adverse event, non-fatal - 1 1 1 - - - - - 1 1 - - - - - - - 1 - - - - - - - 1 - - - - - - - - -      Death - - - - - - - 2 1 1 - 2 - - - - - - - - - - - 1 - - 1 1 - 1 - - - - - -      Refused further study procedures - - - - - - 1 - - - - 2 - - - - - - - - - - - - - - - - - - - - - - - -      Subjects entered open label period 4544 4906 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -      Unspecified 54 3 4 2 - - 2 2 1 - 1 1 - - - - - 1 - - - - - - - - 2 - - - - - - - - -      Lost to follow-up 28 28 7 14 3 2 6 4 5 8 10 32 - - - 12 2 5 - - - - - - 3 1 2 2 2 - - - - - - -      Withdrawal by parent/guardian - - 1 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -      Protocol deviation 5 14 - 1 2 2 - - - 4 6 1 - - 2 6 4 6 - 1 - 1 - - 4 6 5 3 4 3 - - - - - -
Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: SSA:10137 subjects enrolled,10125 vaccinated,4 multiple enrolled.10121 evaluated.SSB:1487 subjects randomised,1485 vaccinated and evaluated.SSC:140 subjects randomised,vaccinated and evaluated.SSD:1465 subjects randomized, vaccinated and evaluated.SSE:3010 subjects vaccinated, and evaluated.SSF:123 subjects randomised,122 vaccinated, evaluated. (16, 347 vaccinated)
Period 2
Period 2 title	SSA: Blinded Period
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	No
Arm title	SSA: BNT162b2 30 microgram: Blinded and Open Label Period
Arm description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Arm title	SSA: Placebo: Blinded Period
Arm description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Normal saline solution of 0.9 percent [%] sodium chloride
Number of subjects in period 2 SSA: BNT162b2 30 microgram: Blinded and Open Label Period SSA: Placebo: Blinded Period Started 4544 4906 Completed 3272 73 Not completed 1272 4833      Adverse event, serious fatal 5 -      Withdrawn by parent/guardian 1 -      Consent withdrawn by subject 135 109      Physician decision 2 3      Adverse event, non-fatal 1 -      No longer meets eligibility criteria 20 11      Refused further study procedures 1 1      Pregnancy - 1      Subjects received BNT162b2 30 microgram - 4430      Unspecified 621 13      Lost to follow-up 109 34      Protocol deviation 377 231
Period 3
Period 3 title	SSA: OL: Placebo then BNT162b2 30 mcg
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Not blinded
Arms
Arm title	SSA: Placebo then BNT162b2 (30 microgram): Open-Label Period
Arm description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Arm type	Experimental
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Normal saline solution of 0.9 percent [%] sodium chloride
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	30 microgram administered intramuscularly
Number of subjects in period 3 SSA: Placebo then BNT162b2 (30 microgram): Open-Label Period Started 4430 Completed 3878 Not completed 552      Adverse event, serious fatal 5      Consent withdrawn by subject 25      No longer meets eligibility criteria 4      Unspecified 429      Lost to follow-up 41      Protocol deviation 48

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	SSA: BNT162b2 30 mcg: Blinded and Open Label Period
Reporting group description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSA: Placebo: Blinded Period
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Reporting group title	SSB: BNT162b2 30 mcg then Placebo
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
Reporting group title	SSB: Placebo then BNT162b2 30 mcg
Reporting group description	Subjects received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
Reporting group title	SSC: BNT162b2 10 mcg
Reporting group description	Subjects received one dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSC:BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 1: Group 1
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 1: Group 2
Reporting group description	Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 1: Group 2b
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 2: Group 3
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
Reporting group title	SSD: Cohort 2: Group 4
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
Reporting group title	SSD: Cohort 3: Group 5
Reporting group description	Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Subjects upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.
Reporting group title	SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg SSD: Cohort 1: Group 1 SSD: Cohort 1: Group 2 SSD: Cohort 1: Group 2b SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 SSD: Cohort 3: Group 5 SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Total Number of subjects 5080 5041 753 732 75 65 216 197 204 315 323 210 30 30 30 482 159 321 20 20 20 20 20 20 305 302 307 307 304 313 21 19 21 20 20 21 16343 Age Categorical Units: Subjects     In utero 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Newborns (0-27 days) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Infants and toddlers (28 days-23 months) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Children (2-11 years) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Adolescents (12-17 years) 46 44 233 228 75 65 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 691     Adults (18-64 years) 3859 3811 520 504 0 0 216 197 204 315 323 210 30 30 30 482 159 321 6 5 5 7 5 9 126 105 121 123 110 109 6 7 6 8 9 9 11987     From 65-84 years 1166 1174 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 14 15 15 13 15 10 176 196 186 183 192 199 15 12 15 12 11 12 3631     85 years and over 9 12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 3 1 0 1 2 5 0 0 0 0 0 0 34 Age Continuous Units: years     arithmetic mean (standard deviation) 51.8 ( 15.24 ) 51.7 ( 15.33 ) 21.4 ( 5.29 ) 21.4 ( 5.38 ) 14.4 ( 1.25 ) 14.2 ( 1.10 ) 38.0 ( 10.80 ) 38.4 ( 10.02 ) 38.6 ( 10.35 ) 41.8 ( 9.33 ) 42.4 ( 9.04 ) 30.3 ( 9.44 ) 39.3 ( 10.12 ) 41.5 ( 8.57 ) 42.8 ( 11.60 ) 40.5 ( 9.67 ) 41.9 ( 9.01 ) 40.4 ( 9.61 ) 67.9 ( 7.55 ) 70.3 ( 7.77 ) 67.4 ( 5.61 ) 66.6 ( 5.55 ) 67.5 ( 5.30 ) 66.4 ( 8.04 ) 66.4 ( 6.57 ) 67.0 ( 6.71 ) 67.0 ( 6.65 ) 66.9 ( 6.79 ) 67.3 ( 6.74 ) 67.5 ( 6.87 ) 68.4 ( 6.09 ) 66.9 ( 4.75 ) 68.1 ( 4.86 ) 67.2 ( 5.70 ) 66.7 ( 4.88 ) 66.0 ( 3.65 ) - Gender Categorical Units: Subjects     Female 2624 2526 434 447 37 33 137 119 121 152 156 106 14 17 15 269 89 180 8 9 14 12 7 11 160 157 153 154 143 162 9 9 13 10 8 12 8527     Male 2456 2515 319 285 38 32 79 78 83 163 167 104 16 13 15 213 70 141 12 11 6 8 13 9 145 145 154 153 161 151 12 10 8 10 12 9 7816 Race Units: Subjects     White 3998 4002 491 493 55 50 16 8 9 237 224 31 25 24 26 389 124 250 16 19 15 17 14 16 268 254 261 262 273 272 21 19 21 20 20 21 12261     Black or African American 470 457 159 155 11 9 176 172 178 21 34 155 2 3 1 34 10 32 1 0 2 2 2 1 19 22 23 20 13 19 0 0 0 0 0 0 2203     American Indian or Alaska Native 86 92 4 6 0 0 1 0 2 1 4 1 0 0 0 2 1 3 0 0 0 0 0 0 0 0 0 2 0 1 0 0 0 0 0 0 206     Asian 288 269 61 58 7 5 4 2 1 42 45 1 2 3 3 42 20 25 3 1 2 1 4 3 13 20 16 20 16 17 0 0 0 0 0 0 994     Native Hawaiian or other Pacific Islander 7 11 1 1 0 1 0 0 0 2 3 0 0 0 0 2 2 1 0 0 0 0 0 0 2 1 0 0 0 0 0 0 0 0 0 0 34     Multiracial 209 197 24 12 1 0 10 11 6 10 12 22 1 0 0 12 2 8 0 0 1 0 0 0 3 5 6 3 1 3 0 0 0 0 0 0 559     Not reported 22 13 13 7 1 0 9 4 8 2 1 0 0 0 0 1 0 2 0 0 0 0 0 0 0 0 1 0 1 1 0 0 0 0 0 0 86 Ethnicity Units: Subjects     Hispanic/Latino 759 750 152 150 15 11 6 0 4 48 46 7 3 4 3 66 17 39 1 1 4 3 2 4 57 38 44 46 44 44 0 0 0 0 0 0 2368     Non-Hispanic/non-Latino 4309 4283 595 577 59 53 209 196 200 266 277 202 27 26 27 413 142 282 19 19 16 17 18 16 248 264 263 261 260 269 21 19 21 20 19 21 13934     Not reported 12 8 6 5 1 1 1 1 0 1 0 1 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 41

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	SSA: BNT162b2 30 mcg: Blinded and Open Label Period
Reporting group description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSA: Placebo: Blinded Period
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Reporting group title	SSB: BNT162b2 30 mcg then Placebo
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
Reporting group title	SSB: Placebo then BNT162b2 30 mcg
Reporting group description	Subjects received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
Reporting group title	SSC: BNT162b2 10 mcg
Reporting group description	Subjects received one dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSC:BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 1: Group 1
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 1: Group 2
Reporting group description	Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 1: Group 2b
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSD: Cohort 2: Group 3
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
Reporting group title	SSD: Cohort 2: Group 4
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
Reporting group title	SSD: Cohort 3: Group 5
Reporting group description	Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Subjects upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.
Reporting group title	SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSA: BNT162b2 30 microgram: Blinded and Open Label Period
Reporting group description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSA: Placebo: Blinded Period
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Reporting group title	SSA: Placebo then BNT162b2 (30 microgram): Open-Label Period
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Subject analysis set title	SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period
Subject analysis set type	Safety analysis
Subject analysis set description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Subject analysis set title	SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Subject analysis set type	Safety analysis
Subject analysis set description	Subjects received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Subject analysis set title	SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Subject analysis set type	Safety analysis
Subject analysis set description	Subjects received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
Subject analysis set title	C4591001: BNT162b2 30 mcg
Subject analysis set type	Safety analysis
Subject analysis set description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

End points Top of page

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population Top of page
End point title	SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population [1]
End point description	Occurrences of first COVID-19 infection in subjects after booster dose without past SARS-CoV-2 infection at interim analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Human Immunodeficiency Virus (HIV) positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From 7 Days after booster vaccination (Surveillance time [1000 person-year]: BNT162b2- 0.823, Placebo- 0.792)
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4659 4614 Units: Number of cases     number (not applicable) 6 123
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	2-Sided CI for Relative vaccine efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	SSA: BNT162b2 30 mcg: Blinded and Open Label Period v SSA: Placebo: Blinded Period
Number of subjects included in analysis	9273
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Adjusted Surveillance Time
Point estimate	95.3
Confidence interval
level	95%
sides	2-sided
lower limit	89.5
upper limit	98.3

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population Top of page

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population Top of page
End point title	SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population [2]
End point description	Occurrences of first COVID-19 infection in subjects after booster dose with and without past SARS-CoV-2 infection at interim analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From 7 Days after booster vaccination (Surveillance time [1000 person-year]: BNT162b2- 0.871, Placebo- 0.835)
Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4934 4863 Units: Number of cases     number (not applicable) 7 124
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	SSA: BNT162b2 30 mcg: Blinded and Open Label Period v SSA: Placebo: Blinded Period
Number of subjects included in analysis	9797
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Adjusted Surveillance Time
Point estimate	94.6
Confidence interval
level	95%
sides	2-sided
lower limit	88.5
upper limit	97.9

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population Top of page

Primary: SSA: Percentage of Subjects Reporting Adverse Events Top of page
End point title	SSA: Percentage of Subjects Reporting Adverse Events [3] [4]
End point description	An AE was any untoward medical occurrence in a subject temporally associated with the use of study intervention, whether or not considered related to the study intervention. Safety population included all randomised subjects who received at least 1 dose of the study intervention. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From booster dose to 1 month after booster dose (Day 1)
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSA reporting groups only. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 5054 5016 Units: Percentage of subjects     number (confidence interval 95%) 26.3 (25.0 to 27.5) 7.1 (6.4 to 7.8)
No statistical analyses for this end point

Primary: SSA: Percentage of Subjects Reporting Adverse Events Top of page

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population Top of page
End point title	SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population [5]
End point description	Occurrences of first COVID-19 infection in subjects after booster dose with and without past SARS-CoV-2 infection at final analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From 7 Days after booster vaccination (Surveillance time [1000 person-year]: BNT162b2- 1.173, Placebo- 0.989)
Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4903 4846 Units: Number of cases     number (not applicable) 67 150
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	SSA: BNT162b2 30 mcg: Blinded and Open Label Period v SSA: Placebo: Blinded Period
Number of subjects included in analysis	9749
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Adjusted Surveillance Time
Point estimate	62.4
Confidence interval
level	95%
sides	2-sided
lower limit	49.5
upper limit	72.2

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population Top of page

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population Top of page
End point title	SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population [6]
End point description	Occurrences of first COVID-19 infection in subjects after booster dose without past SARS-CoV-2 infection at final analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From 7 Days after booster vaccination (Surveillance time [1000 person-year]: BNT162b2- 1.098, Placebo- 0.932)
Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4639 4601 Units: Number of cases     number (not applicable) 63 148
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	2-Sided CI for Relative Vaccine Efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	SSA: BNT162b2 30 mcg: Blinded and Open Label Period v SSA: Placebo: Blinded Period
Number of subjects included in analysis	9240
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Adjusted Surveillance Time
Point estimate	63.9
Confidence interval
level	95%
sides	2-sided
lower limit	51.1
upper limit	73.5

Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population Top of page

Primary: SSA: Percentage of Subjects Reporting Serious Adverse Events Top of page
End point title	SSA: Percentage of Subjects Reporting Serious Adverse Events [7] [8]
End point description	An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalisation or prolongation of existing hospitalisation; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. Safety population included all randomised subjects who received at least 1 dose of the study intervention. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From BNT162b2 dose to 6 months after BNT162b2 dose for original BNT162b2 and original placebo/BNT162b2 groups, from placebo dose to unblinding for original placebo group. Median blinded follow-up period for original placebo subjects was 2.8 months
Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSA reporting groups only. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period Number of subjects analysed 5054 5016 4405 Units: Percentage of subjects     number (confidence interval 95%) 1.4 (1.1 to 1.8) 0.8 (0.6 to 1.1) 1.0 (0.7 to 1.3)
No statistical analyses for this end point

Primary: SSA: Percentage of Subjects Reporting Serious Adverse Events Top of page

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level pre-Vaccination 2 (1 Month After Vaccination 1) Top of page
End point title	SSB: Percentage of Subjects With Elevated Troponin I Level pre-Vaccination 2 (1 Month After Vaccination 1) [9] [10]
End point description	Percentage of subjects with elevated troponin I levels pre vaccination 2 were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Pre-Vaccination 2 (1 month after Vaccination 1)
Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 628 600 Units: Percentage of Subjects     number (confidence interval 95%) 1.1 (0.4 to 2.3) 0.3 (0.0 to 1.2)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level pre-Vaccination 2 (1 Month After Vaccination 1) Top of page

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level Within 5 Days After Vaccination 1 Top of page
End point title	SSB: Percentage of Subjects With Elevated Troponin I Level Within 5 Days After Vaccination 1 [11] [12]
End point description	Percentage of subjects with elevated troponin I levels within 5 days after administration of Vaccination 1 were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Within 5 days after Vaccination 1
Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 719 693 Units: Percentage of subjects     number (confidence interval 95%) 1.0 (0.4 to 2.0) 0.6 (0.2 to 1.5)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level Within 5 Days After Vaccination 1 Top of page

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level pre-Dose; Vaccination 1 Top of page
End point title	SSB: Percentage of Subjects With Elevated Troponin I Level pre-Dose; Vaccination 1 [13] [14]
End point description	Percentage of subjects with elevated troponin I levels before administration of Vaccination 1 were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Pre-dose on Day 1 (Vaccination 1)
Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 751 730 Units: Percentage of subjects     number (confidence interval 95%) 0.7 (0.2 to 1.5) 0.5 (0.1 to 1.4)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level pre-Dose; Vaccination 1 Top of page

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level Within 5 Days After Vaccination 2 Top of page
End point title	SSB: Percentage of Subjects With Elevated Troponin I Level Within 5 Days After Vaccination 2 [15] [16]
End point description	Percentage of subjects with elevated troponin I levels within 5 days after administration of Vaccination 2 were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Within 5 days after vaccination 2
Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 667 634 Units: Percentage of subjets     number (confidence interval 95%) 1.5 (0.7 to 2.7) 0.3 (0.0 to 1.1)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level Within 5 Days After Vaccination 2 Top of page

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level 1 Month After Vaccination 2 Top of page
End point title	SSB: Percentage of Subjects With Elevated Troponin I Level 1 Month After Vaccination 2 [17] [18]
End point description	Percentage of subjects with elevated troponin I levels within 1 month after administration of Vaccination 2 were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after Vaccination 2
Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 676 645 Units: Percentage of subjects     number (confidence interval 95%) 0.7 (0.2 to 1.7) 0.3 (0.0 to 1.1)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Elevated Troponin I Level 1 Month After Vaccination 2 Top of page

Primary: SSB: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 Top of page
End point title	SSB: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 [19] [20]
End point description	Local reactions recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population = all subjects receiving at least 1 dose of study intervention. Here, 'Number of Subjects Analysed' (N) = subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 1
Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 747 728 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any 5.8 (4.2 to 7.7) 0.5 (0.1 to 1.4)     Redness: Mild 4.4 (3.1 to 6.1) 0.4 (0.1 to 1.2)     Redness: Moderate 1.1 (0.5 to 2.1) 0.1 (0.0 to 0.8)     Redness: Severe 0.3 (0.0 to 1.0) 0 (0.0 to 0.5)     Redness: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Swelling: Any 6.6 (4.9 to 8.6) 0.5 (0.1 to 1.4)     Swelling: Mild 5.0 (3.5 to 6.8) 0.4 (0.1 to 1.2)     Swelling: Moderate 1.5 (0.7 to 2.6) 0 (0.0 to 0.5)     Swelling: Severe 0.1 (0.0 to 0.7) 0.1 (0.0 to 0.8)     Swelling: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Pain at injection site: Any 74.4 (71.1 to 77.5) 13.9 (11.4 to 16.6)     Pain at injection site: Mild 48.7 (45.1 to 52.4) 12.2 (9.9 to 14.8)     Pain at injection site: Moderate 25.4 (22.3 to 28.7) 1.6 (0.9 to 2.9)     Pain at injection site: Severe 0.3 (0.0 to 1.0) 0 (0.0 to 0.5)     Pain at injection site: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 Top of page

Primary: SSB: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 Top of page
End point title	SSB: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 [21] [22]
End point description	Local reactions recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population = all subjects receiving at least 1 dose of study intervention. Here, 'Number of Subjects Analysed' (N) = subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 2
Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 706 672 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any 0.7 (0.2 to 1.6) 4.6 (3.2 to 6.5)     Redness: Mild 0.3 (0.0 to 1.0) 2.8 (1.7 to 4.4)     Redness: Moderate 0.4 (0.1 to 1.2) 1.5 (0.7 to 2.7)     Redness: Severe 0 (0.0 to 0.5) 0.3 (0.0 to 1.1)     Redness: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Swelling: Any 0.4 (0.1 to 1.2) 5.5 (3.9 to 7.5)     Swelling: Mild 0.4 (0.1 to 1.2) 3.4 (2.2 to 5.1)     Swelling: Moderate 0 (0.0 to 0.5) 1.9 (1.0 to 3.3)     Swelling: Severe 0 (0.0 to 0.5) 0.1 (0.0 to 0.8)     Swelling: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Pain at injection site: Any 8.8 (6.8 to 11.1) 71.7 (68.2 to 75.1)     Pain at injection site: Mild 6.7 (4.9 to 8.8) 40.3 (36.6 to 44.1)     Pain at injection site: Moderate 2.1 (1.2 to 3.5) 30.5 (27.0 to 34.1)     Pain at injection site: Severe 0 (0.0 to 0.5) 0.9 (0.3 to 1.9)     Pain at injection site: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 Top of page

Primary: SSB: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 Top of page
End point title	SSB: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 [23] [24]
End point description	Systemic events recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalisation). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population, ‘N’=subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 1
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 747 728 Units: Percentage of subjects number (confidence interval 95%)     Fever: >=38 deg C 6.0 (4.4 to 8.0) 1.9 (1.1 to 3.2)     Fever: 38.0 to 38.4 deg C 4.1 (2.8 to 5.8) 1.4 (0.7 to 2.5)     Fever: >38.4 to 38.9 deg C 1.7 (0.9 to 3.0) 0.3 (0.0 to 1.0)     Fever: >38.9 to 40.0 deg C 0.1 (0.0 to 0.7) 0.3 (0.0 to 1.0)     Fever: >40.0 deg C 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Fatigue: Any 54.2 (50.6 to 57.8) 31.9 (28.5 to 35.4)     Fatigue: Mild 27.4 (24.3 to 30.8) 19.5 (16.7 to 22.6)     Fatigue: Moderate 25.3 (22.2 to 28.6) 12.2 (9.9 to 14.8)     Fatigue: Severe 1.5 (0.7 to 2.6) 0.1 (0.0 to 0.8)     Fatigue: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Headache: Any 42.6 (39.0 to 46.2) 28.3 (25.0 to 31.7)     Headache: Mild 24.2 (21.2 to 27.5) 18.0 (15.3 to 21.0)     Headache: Moderate 17.3 (14.6 to 20.2) 10.0 (7.9 to 12.4)     Headache: Severe 1.1 (0.5 to 2.1) 0.3 (0.0 to 1.0)     Headache: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Chills: Any 17.1 (14.5 to 20.0) 5.9 (4.3 to 7.9)     Chills: Mild 10.6 (8.5 to 13.0) 4.4 (3.0 to 6.1)     Chills: Moderate 6.3 (4.7 to 8.3) 1.5 (0.8 to 2.7)     Chills: Severe 0.3 (0.0 to 1.0) 0 (0.0 to 0.5)     Chills: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Vomiting: Any 3.2 (2.1 to 4.7) 0.8 (0.3 to 1.8)     Vomiting: Mild 2.8 (1.7 to 4.3) 0.7 (0.2 to 1.6)     Vomiting: Moderate 0.4 (0.1 to 1.2) 0.1 (0.0 to 0.8)     Vomiting: Severe 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Vomiting: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Diarrhea: Any 7.4 (5.6 to 9.5) 7.4 (5.6 to 9.6)     Diarrhea: Mild 6.4 (4.8 to 8.4) 6.0 (4.4 to 8.0)     Diarrhea: Moderate 0.9 (0.4 to 1.9) 1.4 (0.7 to 2.5)     Diarrhea: Severe 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Diarrhea: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     New or worsened muscle pain: Any 27.6 (24.4 to 30.9) 7.7 (5.9 to 9.9)     New or worsened muscle pain: Mild 14.1 (11.6 to 16.8) 5.1 (3.6 to 6.9)     New or worsened muscle pain: Moderate 13.3 (10.9 to 15.9) 2.5 (1.5 to 3.9)     New or worsened muscle pain: Severe 0.3 (0.0 to 1.0) 0.1 (0.0 to 0.8)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     New or worsened joint pain: Any 12.9 (10.5 to 15.5) 4.5 (3.1 to 6.3)     New or worsened joint pain: Mild 8.3 (6.4 to 10.5) 3.0 (1.9 to 4.5)     New or worsened joint pain: Moderate 4.3 (2.9 to 6.0) 1.5 (0.8 to 2.7)     New or worsened joint pain: Severe 0.3 (0.0 to 1.0) 0 (0.0 to 0.5)     New or worsened joint pain: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 Top of page

Primary: SSB: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 Top of page
End point title	SSB: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 [25] [26]
End point description	Systemic events recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalisation). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population, ‘N’=subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 2
Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 706 672 Units: Percentage of subjects number (confidence interval 95%)     Fever: >=38 deg C 0.4 (0.1 to 1.2) 4.3 (2.9 to 6.1)     Fever: 38.0 to 38.4 deg C 0.3 (0.0 to 1.0) 2.5 (1.5 to 4.0)     Fever: >38.4 to 38.9 deg C 0.1 (0.0 to 0.8) 1.3 (0.6 to 2.5)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 0.5) 0.4 (0.1 to 1.3)     Fever: >40.0 deg C 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Fatigue: Any 17.6 (14.8 to 20.6) 47.3 (43.5 to 51.2)     Fatigue: Mild 8.6 (6.7 to 11.0) 18.8 (15.9 to 21.9)     Fatigue: Moderate 8.5 (6.5 to 10.8) 27.1 (23.8 to 30.6)     Fatigue: Severe 0.4 (0.1 to 1.2) 1.5 (0.7 to 2.7)     Fatigue: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Headache: Any 17.8 (15.1 to 20.9) 39.7 (36.0 to 43.5)     Headache: Mild 10.3 (8.2 to 12.8) 19.8 (16.8 to 23.0)     Headache: Moderate 7.2 (5.4 to 9.4) 19.0 (16.1 to 22.2)     Headache: Severe 0.3 (0.0 to 1.0) 0.9 (0.3 to 1.9)     Headache: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Chills: Any 3.7 (2.4 to 5.3) 22.3 (19.2 to 25.7)     Chills: Mild 2.3 (1.3 to 3.7) 13.2 (10.8 to 16.0)     Chills: Moderate 1.1 (0.5 to 2.2) 8.8 (6.8 to 11.2)     Chills: Severe 0.3 (0.0 to 1.0) 0.3 (0.0 to 1.1)     Chills: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Vomiting: Any 1.0 (0.4 to 2.0) 1.9 (1.0 to 3.3)     Vomiting: Mild 0.7 (0.2 to 1.6) 1.8 (0.9 to 3.1)     Vomiting: Moderate 0.3 (0.0 to 1.0) 0.1 (0.0 to 0.8)     Vomiting: Severe 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Vomiting: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Diarrhea: Any 3.3 (2.1 to 4.8) 8.0 (6.1 to 10.4)     Diarrhea: Mild 2.1 (1.2 to 3.5) 6.5 (4.8 to 8.7)     Diarrhea: Moderate 1.1 (0.5 to 2.2) 1.5 (0.7 to 2.7)     Diarrhea: Severe 0 (0.0 to 0.5) 0 (0.0 to 0.5)     Diarrhea: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     New or worsened muscle pain: Any 4.5 (3.1 to 6.3) 29.2 (25.8 to 32.8)     New or worsened muscle pain: Mild 2.3 (1.3 to 3.7) 15.9 (13.2 to 18.9)     New or worsened muscle pain: Moderate 2.1 (1.2 to 3.5) 12.9 (10.5 to 15.7)     New or worsened muscle pain: Severe 0.1 (0.0 to 0.8) 0.3 (0.0 to 1.1)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)     New or worsened joint pain: Any 3.1 (2.0 to 4.7) 12.2 (9.8 to 14.9)     New or worsened joint pain: Mild 1.6 (0.8 to 2.8) 7.4 (5.6 to 9.7)     New or worsened joint pain: Moderate 1.6 (0.8 to 2.8) 4.8 (3.3 to 6.7)     New or worsened joint pain: Severe 0 (0.0 to 0.5) 0 (0.0 to 0.5)     New or worsened joint pain: Grade 4 0 (0.0 to 0.5) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 Top of page

Primary: SSB: Percentage of Subjects Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2 Top of page
End point title	SSB: Percentage of Subjects Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2 [27] [28]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	Vaccination 2 up to 1 month after Vaccination 2
Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 731 700 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 0.5) 0.1 (0.0 to 0.8)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2 Top of page

Primary: SSB: Percentage of Subjects Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1 Top of page
End point title	SSB: Percentage of Subjects Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1 [29] [30]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	Vaccination 1 up to 1 month after Vaccination 1
Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 753 732 Units: Percentage of subjects     number (confidence interval 95%) 0.1 (0.0 to 0.7) 0.3 (0.0 to 1.0)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1 Top of page

Primary: SSB: Percentage of Subjects Reporting Adverse Events (AEs) 1 Month After Vaccination 1 Top of page
End point title	SSB: Percentage of Subjects Reporting Adverse Events (AEs) 1 Month After Vaccination 1 [31] [32]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs within 1 month after Vaccination 1 were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	Vaccination 1 up to 1 Month After Vaccination 1
Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 753 732 Units: Percentage of subjects     number (confidence interval 95%) 9.4 (7.4 to 11.7) 10.4 (8.3 to 12.8)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects Reporting Adverse Events (AEs) 1 Month After Vaccination 1 Top of page

Primary: SSB: Percentage of Subjects Reporting Adverse Events (AEs) 1 Month After Vaccination 2 Top of page
End point title	SSB: Percentage of Subjects Reporting Adverse Events (AEs) 1 Month After Vaccination 2 [33] [34]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs within 1 month after Vaccination 2 were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Subjects who did not receive Vaccination 2 or who received an incorrect vaccine at Vaccination 2 were excluded from this analysis. Here, ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Vaccination 2 up to 1 month after Vaccination 2
Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSB reporting groups only. [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSB reporting groups only.
End point values SSB: BNT162b2 30 mcg then Placebo SSB: Placebo then BNT162b2 30 mcg Number of subjects analysed 731 700 Units: Percentage of subjects     number (confidence interval 95%) 5.6 (4.1 to 7.5) 7.4 (5.6 to 9.6)
No statistical analyses for this end point

Primary: SSB: Percentage of Subjects Reporting Adverse Events (AEs) 1 Month After Vaccination 2 Top of page

Primary: SSC: Percentage of Subjects With Local Reactions Within 7 Days After Booster (Third) Dose Top of page
End point title	SSC: Percentage of Subjects With Local Reactions Within 7 Days After Booster (Third) Dose [35] [36]
End point description	Local reactions recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after the booster (third) dose and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population = all subjects receiving at least 1 dose of study intervention. Here, 'Number of Subjects Analysed' (N) = subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after the booster (third) dose
Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 75 64 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any 1.3 (0.0 to 7.2) 6.3 (1.7 to 15.2)     Redness: Mild 1.3 (0.0 to 7.2) 4.7 (1.0 to 13.1)     Redness: Moderate 0 (0.0 to 4.8) 1.6 (0.0 to 8.4)     Redness: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Redness: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Swelling: Any 2.7 (0.3 to 9.3) 9.4 (3.5 to 19.3)     Swelling: Mild 2.7 (0.3 to 9.3) 6.3 (1.7 to 15.2)     Swelling: Moderate 0 (0.0 to 4.8) 3.1 (0.4 to 5.6)     Swelling: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Swelling: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Pain at the injection site: Any 56.0 (44.1 to 67.5) 78.1 (66.0 to 87.5)     Pain at the injection site: Mild 40.0 (28.9 to 52.0) 46.9 (34.3 to 59.8)     Pain at the injection site: Moderate 16.0 (8.6 to 26.3) 31.3 (20.2 to 44.1)     Pain at the injection site: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Pain at the injection site: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)
No statistical analyses for this end point

Primary: SSC: Percentage of Subjects With Local Reactions Within 7 Days After Booster (Third) Dose Top of page

Primary: SSC: Percentage of Subjects With Systemic Events Within 7 Days After Booster (Third) Dose Top of page
End point title	SSC: Percentage of Subjects With Systemic Events Within 7 Days After Booster (Third) Dose [37] [38]
End point description	Systemic events recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalisation). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24 h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population, ‘N' = subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after the booster (third) dose
Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 75 64 Units: Percentage of subjects number (confidence interval 95%)     Fever: >=38.0 deg C 4.0 (0.8 to 11.2) 6.3 (1.7 to 15.2)     Fever: >=38.0°C to 38.4 deg C 2.7 (0.3 to 9.3) 3.1 (0.4 to 10.8)     Fever: >38.4°C to 38.9 deg C 0 (0.0 to 4.8) 1.6 (0.0 to 8.4)     Fever: >38.9°C to 40.0 deg C 1.3 (0.0 to 7.2) 0 (0.0 to 5.6)     Fever: >40.0 deg C 0 (0.0 to 4.8) 1.6 (0.0 to 8.4)     Fatigue: Any 49.3 (37.6 to 61.1) 54.7 (41.7 to 67.2)     Fatigue: Mild 22.7 (13.8 to 33.8) 25.0 (15.0 to 37.4)     Fatigue: Moderate 25.3 (16.0 to 36.7) 26.6 (16.3 to 39.1)     Fatigue: Severe 1.3 (0.0 to 7.2) 3.1 (0.4 to 10.8)     Fatigue: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Headache: Any 41.3 (30.1 to 53.3) 53.1 (40.2 to 65.7)     Headache: Mild 21.3 (12.7 to 32.3) 31.3 (20.2 to 44.1)     Headache: Moderate 20.0 (11.6 to 30.8) 20.3 (11.3 to 32.2)     Headache: Severe 0 (0.0 to 4.8) 1.6 (0.0 to 8.4)     Headache: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Chills: Any 13.3 (6.6 to 23.2) 23.4 (13.8 to 35.7)     Chills: Mild 5.3 (1.5 to 13.1) 12.5 (5.6 to 23.2)     Chills: Moderate 8.0 (3.0 to 16.6) 10.9 (4.5 to 21.2)     Chills: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Chills: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Vomiting: Any 1.3 (0.0 to 7.2) 3.1 (0.4 to 10.8)     Vomiting: Mild 0 (0.0 to 4.8) 1.6 (0.0 to 8.4)     Vomiting: Moderate 1.3 (0.0 to 7.2) 1.6 (0.0 to 8.4)     Vomiting: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Vomiting: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Diarrhea: Any 4.0 (0.8 to 11.2) 9.4 (3.5 to 19.3)     Diarrhea: Mild 2.7 (0.3 to 9.3) 9.4 (3.5 to 19.3)     Diarrhea: Moderate 1.3 (0.0 to 7.2) 0 (0.0 to 5.6)     Diarrhea: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     Diarrhea: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     New or worsened muscle pain: Any 24.0 (14.9 to 35.3) 37.5 (25.7 to 50.5)     New or worsened muscle pain: Mild 4.0 (0.8 to 11.2) 20.3 (11.3 to 32.2)     New or worsened muscle pain: Moderate 20.0 (11.6 to 30.8) 17.2 (8.9 to 28.7)     New or worsened muscle pain: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     New or worsened muscle pain: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)     New or worsened joint pain: Any 14.7 (7.6 to 24.7) 15.6 (7.8 to 26.9)     New or worsened joint pain: Mild 5.3 (1.5 to 13.1) 10.9 (4.5 to 21.2)     New or worsened joint pain: Moderate 9.3 (3.8 to 18.3) 4.7 (1.0 to 13.1)     New or worsened joint pain: Severe 0 (0.0 to 4.8) 0 (0.0 to 5.6)     New or worsened joint pain: Grade 4 0 (0.0 to 4.8) 0 (0.0 to 5.6)
No statistical analyses for this end point

Primary: SSC: Percentage of Subjects With Systemic Events Within 7 Days After Booster (Third) Dose Top of page

Primary: SSC: Percentage of Subjects Reporting Adverse Events From Booster (Third) Dose Through 1 Month After Booster (Third) Dose Top of page
End point title	SSC: Percentage of Subjects Reporting Adverse Events From Booster (Third) Dose Through 1 Month After Booster (Third) Dose [39] [40]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs from booster (third) dose up to 1 month after booster (third) dose were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From booster (third) dose up to 1 month after booster (third) dose
Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 75 65 Units: Percentage of subjects     number (confidence interval 95%) 4.0 (0.8 to 11.2) 7.7 (2.5 to 17.0)
No statistical analyses for this end point

Primary: SSC: Percentage of Subjects Reporting Adverse Events From Booster (Third) Dose Through 1 Month After Booster (Third) Dose Top of page

Primary: SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Baseline to 1 Month After the Booster (Third) Dose Top of page
End point title	SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Baseline to 1 Month After the Booster (Third) Dose [41] [42]
End point description	GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline to 1 month after the booster (third) dose was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result for the Visit 303 (1 month after the booster [third] dose), have a blood sample collected within an appropriate window (within 28-42 days after the booster [third] dose), and have no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From baseline to 1 month after the booster (third) dose
Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg C4591001: BNT162b2 30 mcg Number of subjects analysed 65 54 74 Units: Fold rise     geometric mean (confidence interval 95%) 8.6 (6.4 to 11.6) 9.5 (6.5 to 13.9) 18.1 (13.4 to 24.4)
No statistical analyses for this end point

Primary: SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Baseline to 1 Month After the Booster (Third) Dose Top of page

Primary: SSC: Percentage of Subjects Reporting Serious Adverse Events From Booster (Third) Dose Through 6 Months After Booster (Third) Dose Top of page
End point title	SSC: Percentage of Subjects Reporting Serious Adverse Events From Booster (Third) Dose Through 6 Months After Booster (Third) Dose [43] [44]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From booster (third) dose up to 6 months after booster (third) dose
Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 75 65 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 4.8) 1.5 (0.0 to 8.3)
No statistical analyses for this end point

Primary: SSC: Percentage of Subjects Reporting Serious Adverse Events From Booster (Third) Dose Through 6 Months After Booster (Third) Dose Top of page

Primary: SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Baseline (Before the Third Dose) Top of page
End point title	SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Baseline (Before the Third Dose) [45] [46]
End point description	GMT of SARS-CoV-2 reference-strain–neutralizing titers at baseline (before the third dose) was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result for the Visit 303 (1 month after the booster [third] dose), have a blood sample collected within an appropriate window (within 28-42 days after the booster [third] dose), and have no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	At baseline (before the third dose)
Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg C4591001: BNT162b2 30 mcg Number of subjects analysed 65 54 74 Units: Titer     geometric mean (confidence interval 95%) 1337.2 (941.5 to 1899.2) 1648.4 (1087.5 to 2498.6) 424.0 (308.6 to 582.5)
No statistical analyses for this end point

Primary: SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Baseline (Before the Third Dose) Top of page

Primary: SSC: GMT of SARS-CoV-2 Reference-Strain–Neutralizing Titers at 1 Month After the Booster (Third) Dose Top of page
End point title	SSC: GMT of SARS-CoV-2 Reference-Strain–Neutralizing Titers at 1 Month After the Booster (Third) Dose [47] [48]
End point description	GMT of SARS-CoV-2 reference-strain–neutralizing titers at 1 month after the booster (third) dose was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result for the Visit 303 (1 month after the booster [third] dose), have a blood sample collected within an appropriate window (within 28-42 days after the booster [third] dose), and have no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after the booster (third) dose
Notes [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg C4591001: BNT162b2 30 mcg Number of subjects analysed 67 54 75 Units: Titer     geometric mean (confidence interval 95%) 11672.4 (9754.8 to 13967.0) 15680.7 (13308.9 to 18475.2) 7785.4 (6353.0 to 9540.7)
No statistical analyses for this end point

Primary: SSC: GMT of SARS-CoV-2 Reference-Strain–Neutralizing Titers at 1 Month After the Booster (Third) Dose Top of page

Primary: SSC: Percentages of Subjects With Seroresponse to Reference-Strain at 1 Month After the Booster (Third) Dose Top of page
End point title	SSC: Percentages of Subjects With Seroresponse to Reference-Strain at 1 Month After the Booster (Third) Dose [49] [50]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 1 month after the booster (third) dose was reported in this endpoint. Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result for the Visit 303 (1 month after the booster [third] dose), have a blood sample collected within an appropriate window (within 28-42 days after the booster [third] dose), and have no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after the booster (third) dose
Notes [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSC reporting groups only. [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg C4591001: BNT162b2 30 mcg Number of subjects analysed 65 54 74 Units: Percentages of subjects     number (confidence interval 95%) 67.7 (54.9 to 78.8) 66.7 (52.5 to 78.9) 89.2 (79.8 to 95.2)
No statistical analyses for this end point

Primary: SSC: Percentages of Subjects With Seroresponse to Reference-Strain at 1 Month After the Booster (Third) Dose Top of page

Primary: SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 Top of page
End point title	SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 [51] [52]
End point description	Local reactions recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection (inj) site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit/hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population = all subjects receiving at least 1 dose of study intervention. Here, N = subjects who received Vaccination 1 and 'n' = subjects evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 1
Notes [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 1: Group 1 SSD: Cohort 1: Group 2 SSD: Cohort 1: Group 2b SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 SSD: Cohort 3: Group 5 Number of subjects analysed 207 192 201 294 304 188 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any; n=207,192,201,294,304,186 3.4 (1.4 to 6.8) 5.7 (2.9 to 10.0) 2.5 (0.8 to 5.7) 7.1 (4.5 to 10.7) 4.3 (2.3 to 7.2) 5.4 (2.6 to 9.7)     Redness: Mild; n=207,192,201,294,304,186 1.0 (0.1 to 3.4) 4.2 (1.8 to 8.0) 1.0 (0.1 to 3.5) 4.4 (2.4 to 7.4) 3.9 (2.1 to 6.8) 3.2 (1.2 to 6.9)     Redness: Moderate; n=207,192,201,294,304,186 1.4 (0.3 to 4.2) 1.6 (0.3 to 4.5) 1.5 (0.3 to 4.3) 2.7 (1.2 to 5.3) 0.3 (0.0 to 1.8) 2.2 (0.6 to 5.4)     Redness: Severe; n=207,192,201,294,304,186 1.0 (0.1 to 3.4) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Redness: Grade 4; n=207,192,201,294,304,186 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Swelling: Any; n=207,192,201,294,304,186 8.2 (4.9 to 12.8) 7.3 (4.0 to 11.9) 5.5 (2.8 to 9.6) 8.5 (5.6 to 12.3) 8.9 (5.9 to 12.7) 11.3 (7.1 to 16.7)     Swelling: Mild; n=207,192,201,294,304,186 4.3 (2.0 to 8.1) 4.2 (1.8 to 8.0) 4.5 (2.1 to 8.3) 5.4 (3.1 to 8.7) 6.9 (4.3 to 10.4) 6.5 (3.4 to 11.0)     Swelling: Moderate; n=207,192,201,294,304,186 3.9 (1.7 to 7.5) 2.6 (0.9 to 6.0) 1.0 (0.1 to 3.5) 3.1 (1.4 to 5.7) 2.0 (0.7 to 4.2) 4.8 (2.2 to 9.0)     Swelling: Severe; n=207,192,201,294,304,186 0 (0.0 to 1.8) 0.5 (0.0 to 2.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Swelling: Grade 4; n=207,192,201,294,304,186 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Inj site pain:Any;n=207,192,201,294,304,188 46.4 (39.4 to 53.4) 42.7 (35.6 to 50.0) 42.3 (35.4 to 49.4) 78.2 (73.1 to 82.8) 78.9 (73.9 to 83.4) 54.3 (46.8 to 61.5)     Inj site pain: Mild; n=207,192,201,294,304,188 30.9 (24.7 to 37.7) 27.1 (20.9 to 34.0) 32.3 (25.9 to 39.3) 59.2 (53.3 to 64.9) 61.5 (55.8 to 67.0) 27.7 (21.4 to 34.6)     Inj site pain: Moderate; n=207,192,201,294,304,188 15.0 (10.4 to 20.6) 14.1 (9.5 to 19.8) 9.5 (5.8 to 14.4) 18.4 (14.1 to 23.3) 16.4 (12.5 to 21.1) 26.1 (19.9 to 33.0)     Inj site pain: Severe; n=207,192,201,294,304,188 0.5 (0.0 to 2.7) 1.6 (0.3 to 4.5) 0.5 (0.0 to 2.7) 0.7 (0.1 to 2.4) 1.0 (0.2 to 2.9) 0.5 (0.0 to 2.9)     Inj site pain: Grade 4; n=207,192,201,294,304,188 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.9)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 Top of page

Primary: SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 Top of page
End point title	SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 [53] [54]
End point description	Local reactions recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population = all subjects receiving at least 1 dose of study intervention. Here, N = subjects who received Vaccination 2 and 'n' = subjects evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 2
Notes [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 1: Group 2 SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 SSD: Cohort 3: Group 5 Number of subjects analysed 157 196 218 142 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any; n= 157, 196, 217, 140 5.7 (2.7 to 10.6) 5.1 (2.5 to 9.2) 4.1 (1.9 to 7.7) 4.3 (1.6 to 9.1)     Redness: Mild; n= 157, 196, 217, 140 4.5 (1.8 to 9.0) 3.6 (1.4 to 7.2) 4.1 (1.9 to 7.7) 2.1 (0.4 to 6.1)     Redness: Moderate; n= 157, 196, 217, 140 1.3 (0.2 to 4.5) 1.5 (0.3 to 4.4) 0 (0.0 to 1.7) 2.1 (0.4 to 6.1)     Redness: Severe; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Redness: Grade 4; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Swelling: Any; n= 157, 196, 217, 141 8.9 (5.0 to 14.5) 4.1 (1.8 to 7.9) 6.5 (3.6 to 10.6) 9.2 (5.0 to 15.3)     Swelling: Mild; n= 157, 196, 217, 141 7.0 (3.5 to 12.2) 2.0 (0.6 to 5.1) 5.5 (2.9 to 9.5) 5.7 (2.5 to 10.9)     Swelling: Moderate; n= 157, 196, 217, 141 1.3 (0.2 to 4.5) 2.0 (0.6 to 5.1) 0.9 (0.1 to 3.3) 3.5 (1.2 to 8.1)     Swelling: Severe; n= 157, 196, 217, 141 0.6 (0.0 to 3.5) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Swelling: Grade 4; n= 157, 196, 217, 141 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Inj site pain: Any; n= 157, 196, 218, 142 40.1 (32.4 to 48.2) 74.5 (67.8 to 80.4) 70.6 (64.1 to 76.6) 34.5 (26.7 to 42.9)     Inj site pain: Mild; n= 157, 196, 218, 142 29.9 (22.9 to 37.8) 55.6 (48.4 to 62.7) 57.8 (50.9 to 64.4) 21.1 (14.7 to 28.8)     Inj site pain: Moderate; n= 157, 196, 218, 142 10.2 (5.9 to 16.0) 18.9 (13.7 to 25.1) 12.4 (8.3 to 17.5) 13.4 (8.3 to 20.1)     Inj site pain: Severe; n= 157, 196, 218, 142 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0.5 (0.0 to 2.5) 0 (0.0 to 2.6)     Inj site pain: Grade 4; n= 157, 196, 218, 142 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 Top of page

Primary: SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 3 Top of page
End point title	SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 3 [55] [56]
End point description	Local reactions recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after Vaccination 3 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population = all subjects receiving at least 1 dose of study intervention. Here, N = subjects who received Vaccination 3.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 3
Notes [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 3: Group 5 Number of subjects analysed 154 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any 4.5 (1.8 to 9.1)     Redness: Mild 1.3 (0.2 to 4.6)     Redness: Moderate 3.2 (1.1 to 7.4)     Redness: Severe 0 (0.0 to 2.4)     Redness: Grade 4 0 (0.0 to 2.4)     Swelling: Any 10.4 (6.1 to 16.3)     Swelling: Mild 3.2 (1.1 to 7.4)     Swelling: Moderate 7.1 (3.6 to 12.4)     Swelling: Severe 0 (0.0 to 2.4)     Swelling: Grade 4 0 (0.0 to 2.4)     Pain at the injection site: Any 39.0 (31.2 to 47.1)     Pain at the injection site: Mild 19.5 (13.5 to 26.6)     Pain at the injection site: Moderate 18.8 (13.0 to 25.9)     Pain at the injection site: Severe 0.6 (0.0 to 3.6)     Pain at the injection site: Grade 4 0 (0.0 to 2.4)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 3 Top of page

Primary: SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 Top of page
End point title	SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 [57] [58]
End point description	Systemic events recorded in e-diary. Fever:oral temperature >= 38.0 deg C, categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalisation). Vomiting:mild: 1-2 times in 24 h, moderate: >2 times in 24h, severe:required intravenous hydration and Grade 4: ER visit/hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population, ‘N’=subjects who received Vaccination 1.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 1
Notes [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 1: Group 1 SSD: Cohort 1: Group 2 SSD: Cohort 1: Group 2b SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 SSD: Cohort 3: Group 5 Number of subjects analysed 207 192 201 294 304 186 Units: Percentage of subjects number (confidence interval 95%)     Fever: Any 5.8 (3.0 to 9.9) 2.6 (0.9 to 6.0) 5.0 (2.4 to 9.0) 8.8 (5.9 to 12.7) 7.2 (4.6 to 10.8) 4.8 (2.2 to 9.0)     Fever: >=38.0 deg C to 38.4 deg C 4.3 (2.0 to 8.1) 1.6 (0.3 to 4.5) 2.5 (0.8 to 5.7) 4.8 (2.6 to 7.9) 3.9 (2.1 to 6.8) 1.1 (0.1 to 3.8)     Fever: >38.4 deg C to 38.9 deg C 0.5 (0.0 to 2.7) 0.5 (0.0 to 2.9) 1.5 (0.3 to 4.3) 3.4 (1.6 to 6.2) 3.0 (1.4 to 5.5) 2.7 (0.9 to 6.2)     Fever: >38.9 deg C to 40.0 deg C 1.0 (0.1 to 3.4) 0.5 (0.0 to 2.9) 1.0 (0.1 to 3.5) 0.3 (0.0 to 1.9) 0.3 (0.0 to 1.8) 1.1 (0.1 to 3.8)     Fever: >40.0 deg C 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Fever: Unknown 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0.3 (0.0 to 1.9) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Fatigue: Any 32.4 (26.0 to 39.2) 26.6 (20.5 to 33.4) 28.4 (22.2 to 35.1) 64.6 (58.9 to 70.1) 60.5 (54.8 to 66.1) 39.2 (32.2 to 46.7)     Fatigue: Mild 18.8 (13.8 to 24.8) 14.6 (9.9 to 20.4) 16.4 (11.6 to 22.3) 26.5 (21.6 to 32.0) 29.3 (24.2 to 34.7) 16.7 (11.6 to 22.8)     Fatigue: Moderate 12.6 (8.4 to 17.9) 12.0 (7.7 to 17.4) 10.9 (7.0 to 16.1) 34.7 (29.3 to 40.4) 28.9 (23.9 to 34.4) 22.0 (16.3 to 28.7)     Fatigue: Severe 1.0 (0.1 to 3.4) 0 (0.0 to 1.9) 1.0 (0.1 to 3.5) 3.4 (1.6 to 6.2) 2.3 (0.9 to 4.7) 0.5 (0.0 to 3.0)     Fatigue: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Headache: Any 30.9 (24.7 to 37.7) 27.1 (20.9 to 34.0) 27.4 (21.3 to 34.1) 47.6 (41.8 to 53.5) 45.1 (39.4 to 50.8) 27.4 (21.1 to 34.4)     Headache: Mild 20.3 (15.0 to 26.4) 15.6 (10.8 to 21.5) 16.4 (11.6 to 22.3) 27.2 (22.2 to 32.7) 25.7 (20.8 to 31.0) 10.2 (6.3 to 15.5)     Headache: Moderate 10.1 (6.4 to 15.1) 9.4 (5.7 to 14.4) 10.4 (6.6 to 15.5) 18.4 (14.1 to 23.3) 17.4 (13.3 to 22.2) 16.7 (11.6 to 22.8)     Headache: Severe 0.5 (0.0 to 2.7) 2.1 (0.6 to 5.2) 0.5 (0.0 to 2.7) 2.0 (0.8 to 4.4) 2.0 (0.7 to 4.2) 0.5 (0.0 to 3.0)     Headache: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Chills: Any 15.0 (10.4 to 20.6) 11.5 (7.3 to 16.8) 10.4 (6.6 to 15.5) 31.6 (26.4 to 37.3) 26.3 (21.5 to 31.6) 14.0 (9.3 to 19.8)     Chills: Mild 10.1 (6.4 to 15.1) 6.8 (3.7 to 11.3) 8.0 (4.6 to 12.6) 13.3 (9.6 to 17.7) 15.1 (11.3 to 19.7) 7.0 (3.8 to 11.7)     Chills: Moderate 4.3 (2.0 to 8.1) 4.7 (2.2 to 8.7) 2.5 (0.8 to 5.7) 17.0 (12.9 to 21.8) 10.2 (7.0 to 14.2) 7.0 (3.8 to 11.7)     Chills: Severe 0.5 (0.0 to 2.7) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 1.4 (0.4 to 3.4) 1.0 (0.2 to 2.9) 0 (0.0 to 2.0)     Chills: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Vomiting: Any 1.0 (0.1 to 3.4) 2.1 (0.6 to 5.2) 3.5 (1.4 to 7.0) 2.7 (1.2 to 5.3) 1.6 (0.5 to 3.8) 2.2 (0.6 to 5.4)     Vomiting: Mild 1.0 (0.1 to 3.4) 1.6 (0.3 to 4.5) 2.5 (0.8 to 5.7) 2.4 (1.0 to 4.8) 1.6 (0.5 to 3.8) 0.5 (0.0 to 3.0)     Vomiting: Moderate 0 (0.0 to 1.8) 0.5 (0.0 to 2.9) 1.0 (0.1 to 3.5) 0.3 (0.0 to 1.9) 0 (0.0 to 1.2) 1.6 (0.3 to 4.6)     Vomiting: Severe 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Vomiting: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     Diarrhea: Any 9.2 (5.6 to 14.0) 8.3 (4.8 to 13.2) 6.5 (3.5 to 10.8) 8.5 (5.6 to 12.3) 11.5 (8.2 to 15.6) 8.1 (4.6 to 13.0)     Diarrhea: Mild 8.2 (4.9 to 12.8) 7.8 (4.4 to 12.6) 5.0 (2.4 to 9.0) 7.5 (4.7 to 11.1) 9.2 (6.2 to 13.0) 3.8 (1.5 to 7.6)     Diarrhea: Moderate 1.0 (0.1 to 3.4) 0.5 (0.0 to 2.9) 1.5 (0.3 to 4.3) 1.0 (0.2 to 3.0) 2.0 (0.7 to 4.2) 3.8 (1.5 to 7.6)     Diarrhea: Severe 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0.3 (0.0 to 1.8) 0.5 (0.0 to 3.0)     Diarrhea: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     New or worsened muscle pain: Any 15.5 (10.8 to 21.1) 16.1 (11.2 to 22.1) 13.9 (9.5 to 19.5) 34.0 (28.6 to 39.7) 28.3 (23.3 to 33.7) 19.9 (14.4 to 26.4)     New or worsened muscle pain: Mild 7.2 (4.1 to 11.7) 6.8 (3.7 to 11.3) 7.5 (4.2 to 12.0) 14.6 (10.8 to 19.2) 16.8 (12.8 to 21.5) 6.5 (3.4 to 11.0)     New or worsened muscle pain: Moderate 8.2 (4.9 to 12.8) 9.4 (5.7 to 14.4) 6.5 (3.5 to 10.8) 18.7 (14.4 to 23.6) 10.5 (7.3 to 14.5) 12.9 (8.4 to 18.6)     New or worsened muscle pain: Severe 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0.7 (0.1 to 2.4) 1.0 (0.2 to 2.9) 0.5 (0.0 to 3.0)     New or worsened muscle pain: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     New or worsened joint pain: Any 11.1 (7.2 to 16.2) 13.5 (9.0 to 19.2) 10.0 (6.2 to 14.9) 23.5 (18.7 to 28.7) 15.1 (11.3 to 19.7) 12.4 (8.0 to 18.0)     New or worsened joint pain: Mild 5.3 (2.7 to 9.3) 6.8 (3.7 to 11.3) 4.5 (2.1 to 8.3) 10.2 (7.0 to 14.2) 7.9 (5.1 to 11.5) 3.8 (1.5 to 7.6)     New or worsened joint pain: Moderate 5.3 (2.7 to 9.3) 6.3 (3.3 to 10.7) 5.5 (2.8 to 9.6) 12.2 (8.7 to 16.5) 7.2 (4.6 to 10.8) 8.6 (5.0 to 13.6)     New or worsened joint pain: Severe 0.5 (0.0 to 2.7) 0.5 (0.0 to 2.9) 0 (0.0 to 1.8) 1.0 (0.2 to 3.0) 0 (0.0 to 1.2) 0 (0.0 to 2.0)     New or worsened joint pain: Grade 4 0 (0.0 to 1.8) 0 (0.0 to 1.9) 0 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 2.0)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 Top of page

Primary: SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 Top of page
End point title	SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 [59] [60]
End point description	Systemic events recorded in e-diary. Fever:oral temperature >= 38.0 deg C, categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalisation). Vomiting:mild: 1-2 times in 24 h, moderate: >2 times in 24h, severe:required intravenous hydration and Grade 4: ER visit/hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population,‘N’=subjects who received Vaccination 2 and 'n' = subjects evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 2
Notes [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 1: Group 2 SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 SSD: Cohort 3: Group 5 Number of subjects analysed 157 197 219 142 Units: Percentage of subjects number (confidence interval 95%)     Fever: Any; n= 157, 196, 217, 140 1.3 (0.2 to 4.5) 5.1 (2.5 to 9.2) 6.0 (3.2 to 10.0) 2.1 (0.4 to 6.1)     Fever:>=38.0 deg C-38.4 deg C;n=157,196,217,140 0 (0.0 to 2.3) 2.6 (0.8 to 5.9) 3.7 (1.6 to 7.1) 0.7 (0.0 to 3.9)     Fever:>38.4 deg C-38.9 deg C;n=157, 196,217,140 1.3 (0.2 to 4.5) 1.0 (0.1 to 3.6) 1.8 (0.5 to 4.7) 1.4 (0.2 to 5.1)     Fever:>38.9 deg C-40.0 deg C; n=157, 196,217,140 0 (0.0 to 2.3) 1.0 (0.1 to 3.6) 0.5 (0.0 to 2.5) 0 (0.0 to 2.6)     Fever:>40.0 deg C; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Fever: Unknown; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0.5 (0.0 to 2.8) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Fatigue: Any; n= 157, 197, 219, 141 17.8 (12.2 to 24.7) 60.9 (53.7 to 67.8) 54.3 (47.5 to 61.1) 27.0 (19.8 to 35.1)     Fatigue: Mild; n= 157, 197, 219, 141 11.5 (6.9 to 17.5) 27.9 (21.8 to 34.7) 26.9 (21.2 to 33.3) 13.5 (8.3 to 20.2)     Fatigue: Moderate; n= 157, 197, 219, 141 5.7 (2.7 to 10.6) 32.0 (25.5 to 39.0) 25.1 (19.5 to 31.4) 12.1 (7.2 to 18.6)     Fatigue: Severe; n= 157, 197, 219, 141 0.6 (0.0 to 3.5) 1.0 (0.1 to 3.6) 2.3 (0.7 to 5.2) 1.4 (0.2 to 5.0)     Fatigue: Grade 4; n= 157, 197, 219, 141 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Headache: Any; n= 157, 196, 217, 142 24.8 (18.3 to 32.4) 39.8 (32.9 to 47.0) 37.3 (30.9 to 44.1) 19.7 (13.5 to 27.2)     Headache: Mild; n= 157, 196, 217, 142 13.4 (8.5 to 19.7) 26.5 (20.5 to 33.3) 18.0 (13.1 to 23.7) 10.6 (6.0 to 16.8)     Headache: Moderate; n= 157, 196, 217, 142 10.8 (6.4 to 16.8) 13.3 (8.9 to 18.8) 17.1 (12.3 to 22.7) 9.2 (5.0 to 15.1)     Headache: Severe; n= 157, 196, 217, 142 0.6 (0.0 to 3.5) 0 (0.0 to 1.9) 2.3 (0.8 to 5.3) 0 (0.0 to 2.6)     Headache: Grade 4; n= 157, 196, 217, 142 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Chills: Any; n= 157, 197, 217, 140 12.1 (7.4 to 18.3) 21.8 (16.3 to 28.3) 19.4 (14.3 to 25.2) 7.1 (3.5 to 12.7)     Chills: Mild; n= 157, 197, 217, 140 7.0 (3.5 to 12.2) 10.7 (6.7 to 15.8) 12.4 (8.4 to 17.6) 2.1 (0.4 to 6.1)     Chills: Moderate; n= 157, 197, 217, 140 5.1 (2.2 to 9.8) 10.7 (6.7 to 15.8) 6.5 (3.6 to 10.6) 5.0 (2.0 to 10.0)     Chills: Severe; n= 157, 197, 217, 140 0 (0.0 to 2.3) 0.5 (0.0 to 2.8) 0.5 (0.0 to 2.5) 0 (0.0 to 2.6)     Chills: Grade 4; n= 157, 197, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Vomiting: Any; n= 157, 196, 217, 140 2.5 (0.7 to 6.4) 0.5 (0.0 to 2.8) 1.8 (0.5 to 4.7) 2.1 (0.4 to 6.1)     Vomiting: Mild; n= 157, 196, 217, 140 1.9 (0.4 to 5.5) 0.5 (0.0 to 2.8) 1.8 (0.5 to 4.7) 2.1 (0.4 to 6.1)     Vomiting: Moderate; n= 157, 196, 217, 140 0.6 (0.0 to 3.5) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Vomiting: Severe; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Vomiting: Grade 4; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Diarrhea: Any; n= 157, 196, 217, 140 5.1 (2.2 to 9.8) 9.7 (5.9 to 14.7) 6.0 (3.2 to 10.0) 6.4 (3.0 to 11.9)     Diarrhea: Mild; n= 157, 196, 217, 140 3.8 (1.4 to 8.1) 8.2 (4.7 to 12.9) 5.1 (2.6 to 8.9) 4.3 (1.6 to 9.1)     Diarrhea: Moderate; n= 157, 196, 217, 140 1.3 (0.2 to 4.5) 1.5 (0.3 to 4.4) 0.9 (0.1 to 3.3) 2.1 (0.4 to 6.1)     Diarrhea: Severe; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     Diarrhea: Grade 4; n= 157, 196, 217, 140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     New or worsened muscle pain:Any;n=157,196,217,140 10.8 (6.4 to 16.8) 27.6 (21.4 to 34.4) 26.7 (21.0 to 33.1) 8.6 (4.5 to 14.5)     New or worsened muscle pain:Mild;n=157,196,217,140 5.7 (2.7 to 10.6) 17.9 (12.8 to 23.9) 14.7 (10.3 to 20.2) 4.3 (1.6 to 9.1)     New/worsened musclepain:Moderate;n=157,196,217,140 4.5 (1.8 to 9.0) 9.7 (5.9 to 14.7) 11.1 (7.2 to 16.0) 4.3 (1.6 to 9.1)     New/worsened muscle pain:Severe;n=157,196,217,140 0.6 (0.0 to 3.5) 0 (0.0 to 1.9) 0.9 (0.1 to 3.3) 0 (0.0 to 2.6)     New/worsened muscle pain:Grade 4;n=157,196,217,140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     New or worsened joint pain:Any;n=157,196,217,140 7.6 (4.0 to 13.0) 14.3 (9.7 to 20.0) 12.0 (8.0 to 17.1) 5.7 (2.5 to 10.9)     New or worsened joint pain:Mild;n=157,196,217,140 3.2 (1.0 to 7.3) 7.1 (4.0 to 11.7) 6.5 (3.6 to 10.6) 2.1 (0.4 to 6.1)     New/worsened joint pain:Moderate;n=157,196,217,140 4.5 (1.8 to 9.0) 6.1 (3.2 to 10.5) 5.5 (2.9 to 9.5) 3.6 (1.2 to 8.1)     New/worsened joint pain:Severe;n=157,196,217,140 0 (0.0 to 2.3) 1.0 (0.1 to 3.6) 0 (0.0 to 1.7) 0 (0.0 to 2.6)     New/worsened joint pain:Grade 4;n=157,196,217,140 0 (0.0 to 2.3) 0 (0.0 to 1.9) 0 (0.0 to 1.7) 0 (0.0 to 2.6)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 Top of page

Primary: SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 3 Top of page
End point title	SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 3 [61] [62]
End point description	Systemic events recorded in e-diary. Fever: oral temperature >= 38.0 deg C and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalisation). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population, ‘N’=subjects who received vaccination 3.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after Vaccination 3
Notes [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 3: Group 5 Number of subjects analysed 154 Units: Percentage of subjects number (confidence interval 95%)     Fever: Any 2.6 (0.7 to 6.5)     Fever: >=38.0 deg C to 38.4 deg C 0.6 (0.0 to 3.6)     Fever: >38.4 deg C to 38.9 deg C 1.3 (0.2 to 4.6)     Fever: >38.9 deg C to 40.0 deg C 0.6 (0.0 to 3.6)     Fever: >40.0 deg C 0 (0.0 to 2.4)     Fatigue: Any 22.7 (16.4 to 30.2)     Fatigue: Mild 3.9 (1.4 to 8.3)     Fatigue: Moderate 18.2 (12.4 to 25.2)     Fatigue: Severe 0.6 (0.0 to 3.6)     Fatigue: Grade 4 0 (0.0 to 2.4)     Headache: Any 25.3 (18.7 to 33.0)     Headache: Mild 9.1 (5.1 to 14.8)     Headache: Moderate 14.9 (9.7 to 21.6)     Headache: Severe 1.3 (0.2 to 4.6)     Headache: Grade 4 0 (0.0 to 2.4)     Chills: Any 9.1 (5.1 to 14.8)     Chills: Mild 4.5 (1.8 to 9.1)     Chills: Moderate 3.2 (1.1 to 7.4)     Chills: Severe 1.3 (0.2 to 4.6)     Chills: Grade 4 0 (0.0 to 2.4)     Vomiting: Any 2.6 (0.7 to 6.5)     Vomiting: Mild 1.3 (0.2 to 4.6)     Vomiting: Moderate 1.3 (0.2 to 4.6)     Vomiting: Severe 0 (0.0 to 2.4)     Vomiting: Grade 4 0 (0.0 to 2.4)     Diarrhea: Any 1.9 (0.4 to 5.6)     Diarrhea: Mild 1.3 (0.2 to 4.6)     Diarrhea: Moderate 0.6 (0.0 to 3.6)     Diarrhea: Severe 0 (0.0 to 2.4)     Diarrhea: Grade 4 0 (0.0 to 2.4)     New or worsened muscle pain: Any 14.9 (9.7 to 21.6)     New or worsened muscle pain: Mild 4.5 (1.8 to 9.1)     New or worsened muscle pain: Moderate 10.4 (6.1 to 16.3)     New or worsened muscle pain: Severe 0 (0.0 to 2.4)     New or worsened muscle pain: Grade 4 0 (0.0 to 2.4)     New or worsened joint pain: Any 9.1 (5.1 to 14.8)     New or worsened joint pain: Mild 3.2 (1.1 to 7.4)     New or worsened joint pain: Moderate 5.2 (2.3 to 10.0)     New or worsened joint pain: Severe 0.6 (0.0 to 3.6)     New or worsened joint pain: Grade 4 0 (0.0 to 2.4)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 3 Top of page

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1 Top of page
End point title	SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1 [63] [64]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs from first study vaccination (Day 1) up to 1 month after last study vaccination were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Day 1 up to 1 month after last study vaccination
Notes [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 1: Group 1 SSD: Cohort 1: Group 2 SSD: Cohort 1: Group 2b Number of subjects analysed 216 197 204 Units: Percentage of subjects     number (confidence interval 95%) 3.2 (1.3 to 6.6) 6.1 (3.2 to 10.4) 2.0 (0.5 to 4.9)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1 Top of page

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3 Top of page
End point title	SSD: Percentage of Subjects Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3 [65] [66]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs from Vaccination 3 up to 1 month after Vaccination 3 were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From Vaccination 3 up to 1 month after Vaccination 3
Notes [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 3: Group 5 Number of subjects analysed 172 Units: Percentage of subjects     number (confidence interval 95%) 0.6 (0.0 to 3.2)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3 Top of page

Primary: SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3 Top of page
End point title	SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3 [67] [68]
End point description	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From first study vaccination (Day 1) up to 6 months after last study vaccination
Notes [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 1: Group 1 SSD: Cohort 1: Group 2 SSD: Cohort 1: Group 2b SSD: Cohort 3: Group 5 Number of subjects analysed 216 197 204 210 Units: Percentage of subjects     number (confidence interval 95%) 0.9 (0.1 to 3.3) 1.5 (0.3 to 4.4) 1.0 (0.1 to 3.5) 3.8 (1.7 to 7.4)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3 Top of page

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3 Top of page
End point title	SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3 [69] [70]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 2 were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From first study vaccination (Day 1) up to 1 month after Vaccination 2
Notes [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 3: Group 5 Number of subjects analysed 210 Units: Percentage of subjects     number (confidence interval 95%) 6.7 (3.7 to 10.9)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3 Top of page

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2 Top of page
End point title	SSD: Percentage of Subjects Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2 [71] [72]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs from Vaccination 2 up to 1 month after Vaccination 2 were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From Vaccination 2 up to 1 month after Vaccination 2
Notes [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 Number of subjects analysed 213 238 Units: Percentage of subjects     number (confidence interval 95%) 2.3 (0.8 to 5.4) 3.8 (1.7 to 7.1)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2 Top of page

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2 Top of page
End point title	SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2 [73] [74]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 1 were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From first study vaccination (Day 1) up to 1 month after Vaccination 1
Notes [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 Number of subjects analysed 315 323 Units: Percentage of subjects     number (confidence interval 95%) 4.1 (2.2 to 7.0) 3.7 (1.9 to 6.4)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2 Top of page

Primary: SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 Top of page
End point title	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 [75]
End point description	GMT of SARS-CoV-2 Omicron strain–neutralizing titers at 1 month after first study vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result within 28-42 days after the first study vaccination, and have no other important protocol deviations as determined by the clinician. Subjects without evidence of prior infection in the primary immunogenicity subset (175 in each group) were included in analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after first study vaccination
Notes [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 Number of subjects analysed 132 141 Units: Titer     geometric mean (confidence interval 95%) 1929.2 (1631.5 to 2281.1) 1099.6 (932.0 to 1297.4)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI [30 mcg] - BNT162b2 [30 μg]) and the corresponding CI (based on the student t distribution).
Comparison groups	SSD: Cohort 2: Group 3 v SSD: Cohort 2: Group 4
Number of subjects included in analysis	273
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Geometric Mean Ration (GMR)
Point estimate	1.75
Confidence interval
level	95%
sides	2-sided
lower limit	1.39
upper limit	2.22

Primary: SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 Top of page

Primary: SSD: Percentages of Subjects With Seroresponse to the SARS-CoV-2 Omicron Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 Top of page
End point title	SSD: Percentages of Subjects With Seroresponse to the SARS-CoV-2 Omicron Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 [76]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse 1 month after first study vaccination was reported in this endpoint. Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result within 28-42 days after the first study vaccination, and have no other important protocol deviations as determined by the clinician. Subjects without evidence of prior infection in the primary immunogenicity subset (175 in each group) were included in analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after first study vaccination
Notes [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 Number of subjects analysed 130 140 Units: Percentages of subjects     number (confidence interval 95%) 62.3 (53.4 to 70.7) 39.3 (31.1 to 47.9)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	Difference in proportions, expressed as a percentage (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Comparison groups	SSD: Cohort 2: Group 3 v SSD: Cohort 2: Group 4
Number of subjects included in analysis	270
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Difference in Percentages
Point estimate	23
Confidence interval
level	95%
sides	2-sided
lower limit	11.1
upper limit	34.3

Primary: SSD: Percentages of Subjects With Seroresponse to the SARS-CoV-2 Omicron Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 Top of page

Primary: SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2 Top of page
End point title	SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2 [77] [78]
End point description	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From first study vaccination (Day 1) up to 6 months after vaccination 2
Notes [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 Number of subjects analysed 213 238 Units: Percentage of subjects     number (confidence interval 95%) 0.5 (0.0 to 2.6) 1.3 (0.3 to 3.6)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2 Top of page

Primary: SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1: Cohort 2 Top of page
End point title	SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1: Cohort 2 [79] [80]
End point description	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From first study vaccination (Day 1) up to 6 months after vaccination 1
Notes [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSD reporting groups only. [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSD reporting groups only.
End point values SSD: Cohort 2: Group 3 SSD: Cohort 2: Group 4 Number of subjects analysed 315 323 Units: Percentage of Subjects     number (confidence interval 95%) 1.6 (0.5 to 3.7) 0.6 (0.1 to 2.2)
No statistical analyses for this end point

Primary: SSD: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1: Cohort 2 Top of page

Primary: SSE: Percentage of Subjects With Local Reactions Within 7 Days After Study Vaccination Top of page
End point title	SSE: Percentage of Subjects With Local Reactions Within 7 Days After Study Vaccination [81] [82]
End point description	Local reactions were recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm),severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis/exfoliative dermatitis [redness]).Pain at injection site was graded as mild (did not interfere with activity),moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit/hospitalisation for severe pain). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions within 7 days after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population included all subjects receiving at least 1 dose of study intervention. Here, 'Number of Subjects Analysed (N)' = subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after study vaccination
Notes [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSE reporting groups only. [82] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 30 30 30 480 158 320 20 20 20 20 20 20 298 298 301 301 301 312 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any 6.7 (0.8 to 22.1) 0 (0.0 to 11.6) 6.7 (0.8 to 22.1) 8.1 (5.8 to 10.9) 6.3 (3.1 to 11.3) 10.9 (7.7 to 14.9) 0 (0.0 to 16.8) 15.0 (3.2 to 37.9) 20.0 (5.7 to 43.7) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 10.0 (1.2 to 31.7) 6.4 (3.9 to 9.8) 10.4 (7.2 to 14.4) 6.3 (3.8 to 9.7) 10.6 (7.4 to 14.7) 7.0 (4.4 to 10.5) 7.4 (4.7 to 10.9)     Redness: Mild 6.7 (0.8 to 22.1) 0 (0.0 to 11.6) 6.7 (0.8 to 22.1) 3.8 (2.2 to 5.9) 4.4 (1.8 to 8.9) 6.3 (3.9 to 9.5) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 10.0 (1.2 to 31.7) 4.0 (2.1 to 6.9) 6.0 (3.6 to 9.4) 3.3 (1.6 to 6.0) 4.0 (2.1 to 6.9) 4.3 (2.3 to 7.3) 3.5 (1.8 to 6.2)     Redness: Moderate 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 4.2 (2.6 to 6.4) 1.9 (0.4 to 5.4) 4.4 (2.4 to 7.2) 0 (0.0 to 16.8) 10.0 (1.2 to 31.7) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 2.0 (0.7 to 4.3) 4.0 (2.1 to 6.9) 2.7 (1.2 to 5.2) 6.6 (4.1 to 10.1) 2.7 (1.2 to 5.2) 3.2 (1.5 to 5.8)     Redness: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0.2 (0.0 to 1.2) 0 (0.0 to 2.3) 0.3 (0.0 to 1.7) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0.3 (0.0 to 1.9) 0.3 (0.0 to 1.9) 0.3 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0.6 (0.1 to 2.3)     Redness: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Swelling: Any 0 (0.0 to 11.6) 6.7 (0.8 to 22.1) 20.0 (7.7 to 38.6) 9.6 (7.1 to 12.6) 7.0 (3.5 to 12.1) 11.9 (8.5 to 15.9) 0 (0.0 to 16.8) 10.0 (1.2 to 31.7) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 6.0 (3.6 to 9.4) 13.1 (9.5 to 17.5) 8.3 (5.4 to 12.0) 10.0 (6.8 to 13.9) 6.6 (4.1 to 10.1) 5.4 (3.2 to 8.6)     Swelling: Mild 0 (0.0 to 11.6) 6.7 (0.8 to 22.1) 13.3 (3.8 to 30.7) 5.0 (3.2 to 7.3) 4.4 (1.8 to 8.9) 6.3 (3.9 to 9.5) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 10.0 (1.2 to 31.7) 3.4 (1.6 to 6.1) 7.7 (5.0 to 11.4) 5.0 (2.8 to 8.1) 4.0 (2.1 to 6.9) 4.7 (2.6 to 7.7) 2.9 (1.3 to 5.4)     Swelling: Moderate 0 (0.0 to 11.6) 0 (0.0 to 11.6) 6.7 (0.8 to 22.1) 4.4 (2.7 to 6.6) 2.5 (0.7 to 6.4) 5.3 (3.1 to 8.4) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 2.7 (1.2 to 5.2) 5.4 (3.1 to 8.6) 3.3 (1.6 to 6.0) 5.3 (3.1 to 8.5) 2.0 (0.7 to 4.3) 2.2 (0.9 to 4.6)     Swelling: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0.2 (0.0 to 1.2) 0 (0.0 to 2.3) 0.3 (0.0 to 1.7) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0.7 (0.1 to 2.4) 0 (0.0 to 1.2) 0.3 (0.0 to 1.8)     Swelling: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Pain at the injection site: Any 90.0 (73.5 to 97.9) 83.3 (65.3 to 94.4) 96.7 (82.8 to 99.9) 82.9 (79.2 to 86.2) 81.0 (74.0 to 86.8) 86.3 (82.0 to 89.8) 70.0 (45.7 to 88.1) 70.0 (45.7 to 88.1) 65.0 (40.8 to 84.6) 100.0 (83.2 to 100.0) 65.0 (40.8 to 84.6) 85.0 (62.1 to 96.8) 60.1 (54.3 to 65.7) 71.1 (65.6 to 76.2) 66.1 (60.5 to 71.4) 70.8 (65.3 to 75.8) 58.1 (52.3 to 63.8) 67.9 (62.5 to 73.1)     Pain at the injection site: Mild 60.0 (40.6 to 77.3) 76.7 (57.7 to 90.1) 33.3 (17.3 to 52.8) 55.2 (50.6 to 59.7) 67.7 (59.8 to 74.9) 45.3 (39.8 to 50.9) 55.0 (31.5 to 76.9) 65.0 (40.8 to 84.6) 55.0 (31.5 to 76.9) 75.0 (50.9 to 91.3) 60.0 (36.1 to 80.9) 45.0 (23.1 to 68.5) 51.7 (45.8 to 57.5) 53.4 (47.5 to 59.1) 52.8 (47.0 to 58.6) 44.9 (39.1 to 50.7) 52.8 (47.0 to 58.6) 55.4 (49.7 to 61.0)     Pain at the injection site: Moderate 30.0 (14.7 to 49.4) 6.7 (0.8 to 22.1) 60.0 (40.6 to 77.3) 26.0 (22.2 to 30.2) 13.3 (8.4 to 19.6) 39.4 (34.0 to 45.0) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 25.0 (8.7 to 49.1) 5.0 (0.1 to 24.9) 40.0 (19.1 to 63.9) 8.1 (5.2 to 11.7) 17.4 (13.3 to 22.2) 13.3 (9.7 to 17.7) 25.2 (20.4 to 30.6) 5.0 (2.8 to 8.1) 12.2 (8.8 to 16.3)     Pain at the injection site: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 3.3 (0.1 to 17.2) 1.7 (0.7 to 3.3) 0 (0.0 to 2.3) 1.6 (0.5 to 3.6) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0.3 (0.0 to 1.9) 0.3 (0.0 to 1.9) 0 (0.0 to 1.2) 0.7 (0.1 to 2.4) 0.3 (0.0 to 1.8) 0.3 (0.0 to 1.8)     Pain at the injection site: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: SSE: Percentage of Subjects With Local Reactions Within 7 Days After Study Vaccination Top of page

Primary: SSE: Percentage of Subjects With Systemic Events Within 7 Days After Study Vaccination Top of page
End point title	SSE: Percentage of Subjects With Systemic Events Within 7 Days After Study Vaccination [83] [84]
End point description	Systemic events recorded in e-diary. Fever:oral temperature greater than or equal to 38.0 deg C and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C & >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalisation). Vomiting: mild: 1-2 times in 24 h, moderate: > 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population= all subjects receiving at least 1 dose of study intervention. N=subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after study vaccination
Notes [83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSE reporting groups only. [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 30 30 30 480 158 320 20 20 20 20 20 20 298 298 301 301 301 312 Units: Percentage of subjects number (confidence interval 95%)     Fever: >= 38.0 deg C 13.3 (3.8 to 30.7) 0 (0.0 to 11.6) 10.0 (2.1 to 26.5) 10.0 (7.5 to 13.0) 10.8 (6.4 to 16.7) 19.4 (15.2 to 24.1) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 20.0 (5.7 to 43.7) 20.0 (5.7 to 43.7) 3.7 (1.9 to 6.5) 7.4 (4.7 to 11.0) 8.3 (5.4 to 12.0) 9.0 (6.0 to 12.8) 5.0 (2.8 to 8.1) 7.7 (5.0 to 11.2)     Fever: >= 38.0 deg C to 38.4 deg C 3.3 (0.1 to 17.2) 0 (0.0 to 11.6) 10.0 (2.1 to 26.5) 4.2 (2.6 to 6.4) 6.3 (3.1 to 11.3) 6.9 (4.4 to 10.2) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 2.0 (0.7 to 4.3) 3.7 (1.9 to 6.5) 3.7 (1.8 to 6.4) 4.7 (2.6 to 7.7) 3.7 (1.8 to 6.4) 5.4 (3.2 to 8.6)     Fever: >38.4 deg C to 38.9 deg C 10.0 (2.1 to 26.5) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 3.8 (2.2 to 5.9) 3.8 (1.4 to 8.1) 8.1 (5.4 to 11.7) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 1.7 (0.5 to 3.9) 3.7 (1.9 to 6.5) 3.7 (1.8 to 6.4) 2.7 (1.2 to 5.2) 0 (0.0 to 1.2) 1.6 (0.5 to 3.7)     Fever: >38.9 deg C to 40.0 deg C 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 2.1 (1.0 to 3.8) 0.6 (0.0 to 3.5) 4.4 (2.4 to 7.2) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 1.0 (0.2 to 2.9) 1.3 (0.4 to 3.4) 1.3 (0.4 to 3.4) 0.6 (0.1 to 2.3)     Fever: >40 deg C 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0.3 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Fatigue: Any 66.7 (47.2 to 82.7) 63.3 (43.9 to 80.1) 70.0 (50.6 to 85.3) 73.8 (69.6 to 77.6) 68.4 (60.5 to 75.5) 77.5 (72.5 to 82.0) 45.0 (23.1 to 68.5) 55.0 (31.5 to 76.9) 45.0 (23.1 to 68.5) 65.0 (40.8 to 84.6) 40.0 (19.1 to 63.9) 70.0 (45.7 to 88.1) 45.3 (39.6 to 51.1) 52.3 (46.5 to 58.1) 52.5 (46.7 to 58.3) 58.8 (53.0 to 64.4) 49.2 (43.4 to 55.0) 57.4 (51.7 to 62.9)     Fatigue: Mild 20.0 (7.7 to 38.6) 26.7 (12.3 to 45.9) 23.3 (9.9 to 42.3) 25.2 (21.4 to 29.3) 32.3 (25.1 to 40.2) 25.9 (21.2 to 31.1) 30.0 (11.9 to 54.3) 15.0 (3.2 to 37.9) 10.0 (1.2 to 31.7) 35.0 (15.4 to 59.2) 15.0 (3.2 to 37.9) 45.0 (23.1 to 68.5) 23.5 (18.8 to 28.7) 22.5 (17.9 to 27.7) 20.3 (15.9 to 25.3) 24.6 (19.8 to 29.9) 29.2 (24.2 to 34.7) 27.2 (22.4 to 32.5)     Fatigue: Moderate 43.3 (25.5 to 62.6) 33.3 (17.3 to 52.8) 40.0 (22.7 to 59.4) 44.0 (39.5 to 48.5) 34.8 (27.4 to 42.8) 46.9 (41.3 to 52.5) 10.0 (1.2 to 31.7) 40.0 (19.1 to 63.9) 35.0 (15.4 to 59.2) 30.0 (11.9 to 54.3) 25.0 (8.7 to 49.1) 25.0 (8.7 to 49.1) 21.5 (17.0 to 26.6) 26.8 (21.9 to 32.3) 29.6 (24.5 to 35.1) 30.6 (25.4 to 36.1) 18.3 (14.1 to 23.1) 28.2 (23.3 to 33.5)     Fatigue: Severe 3.3 (0.1 to 17.2) 3.3 (0.1 to 17.2) 6.7 (0.8 to 22.1) 4.6 (2.9 to 6.9) 1.3 (0.2 to 4.5) 4.7 (2.6 to 7.6) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0.3 (0.0 to 1.9) 3.0 (1.4 to 5.7) 2.7 (1.2 to 5.2) 3.7 (1.8 to 6.4) 1.7 (0.5 to 3.8) 1.9 (0.7 to 4.1)     Fatigue: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Headache: Any 46.7 (28.3 to 65.7) 30.0 (14.7 to 49.4) 60.0 (40.6 to 77.3) 53.5 (49.0 to 58.1) 50.0 (42.0 to 58.0) 57.5 (51.9 to 63.0) 20.0 (5.7 to 43.7) 30.0 (11.9 to 54.3) 35.0 (15.4 to 59.2) 15.0 (3.2 to 37.9) 30.0 (11.9 to 54.3) 50.0 (27.2 to 72.8) 26.5 (21.6 to 31.9) 38.9 (33.4 to 44.7) 36.5 (31.1 to 42.3) 36.5 (31.1 to 42.3) 33.6 (28.2 to 39.2) 36.5 (31.2 to 42.1)     Headache: Mild 40.0 (22.7 to 59.4) 23.3 (9.9 to 42.3) 26.7 (12.3 to 45.9) 27.7 (23.7 to 31.9) 29.1 (22.2 to 36.9) 27.5 (22.7 to 32.7) 10.0 (1.2 to 31.7) 30.0 (11.9 to 54.3) 30.0 (11.9 to 54.3) 10.0 (1.2 to 31.7) 20.0 (5.7 to 43.7) 25.0 (8.7 to 49.1) 15.8 (11.8 to 20.4) 23.5 (18.8 to 28.7) 22.3 (17.7 to 27.4) 20.6 (16.2 to 25.6) 23.6 (18.9 to 28.8) 24.4 (19.7 to 29.5)     Headache: Moderate 6.7 (0.8 to 22.1) 6.7 (0.8 to 22.1) 30.0 (14.7 to 49.4) 24.2 (20.4 to 28.3) 19.0 (13.2 to 26.0) 27.2 (22.4 to 32.4) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 25.0 (8.7 to 49.1) 10.4 (7.2 to 14.4) 14.4 (10.6 to 18.9) 13.3 (9.7 to 17.7) 14.6 (10.8 to 19.1) 9.6 (6.5 to 13.5) 10.9 (7.7 to 14.9)     Headache: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 3.3 (0.1 to 17.2) 1.7 (0.7 to 3.3) 1.9 (0.4 to 5.4) 2.8 (1.3 to 5.3) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0.3 (0.0 to 1.9) 1.0 (0.2 to 2.9) 1.0 (0.2 to 2.9) 1.3 (0.4 to 3.4) 0.3 (0.0 to 1.8) 1.3 (0.4 to 3.2)     Headache: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Chills: Any 23.3 (9.9 to 42.3) 23.3 (9.9 to 42.3) 40.0 (22.7 to 59.4) 35.6 (31.3 to 40.1) 27.8 (21.0 to 35.5) 38.4 (33.1 to 44.0) 5.0 (0.1 to 24.9) 20.0 (5.7 to 43.7) 15.0 (3.2 to 37.9) 35.0 (15.4 to 59.2) 25.0 (8.7 to 49.1) 30.0 (11.9 to 54.3) 16.4 (12.4 to 21.1) 24.2 (19.4 to 29.4) 25.6 (20.7 to 30.9) 25.6 (20.7 to 30.9) 13.0 (9.4 to 17.3) 23.7 (19.1 to 28.8)     Chills: Mild 13.3 (3.8 to 30.7) 13.3 (3.8 to 30.7) 13.3 (3.8 to 30.7) 20.4 (16.9 to 24.3) 15.8 (10.5 to 22.5) 18.8 (14.6 to 23.5) 0 (0.0 to 16.8) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 30.0 (11.9 to 54.3) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 10.7 (7.5 to 14.8) 13.1 (9.5 to 17.5) 13.0 (9.4 to 17.3) 11.3 (8.0 to 15.4) 8.3 (5.4 to 12.0) 13.5 (9.9 to 17.8)     Chills: Moderate 10.0 (2.1 to 26.5) 10.0 (2.1 to 26.5) 20.0 (7.7 to 38.6) 14.6 (11.5 to 18.1) 11.4 (6.9 to 17.4) 17.8 (13.8 to 22.5) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 20.0 (5.7 to 43.7) 15.0 (3.2 to 37.9) 5.7 (3.4 to 9.0) 10.4 (7.2 to 14.4) 12.0 (8.5 to 16.2) 12.0 (8.5 to 16.2) 4.7 (2.6 to 7.7) 10.3 (7.1 to 14.2)     Chills: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 6.7 (0.8 to 22.1) 0.6 (0.1 to 1.8) 0.6 (0.0 to 3.5) 1.9 (0.7 to 4.0) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 1.2) 0.7 (0.1 to 2.4) 0.7 (0.1 to 2.4) 2.3 (0.9 to 4.7) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Chills: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Vomiting: Any 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 3.1 (1.8 to 5.1) 0.6 (0.0 to 3.5) 3.8 (2.0 to 6.5) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 1.3 (0.4 to 3.4) 1.7 (0.5 to 3.9) 3.0 (1.4 to 5.6) 2.7 (1.2 to 5.2) 1.7 (0.5 to 3.8) 1.3 (0.4 to 3.2)     Vomiting: Mild 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 2.7 (1.4 to 4.6) 0.6 (0.0 to 3.5) 3.4 (1.7 to 6.1) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0.7 (0.1 to 2.4) 1.3 (0.4 to 3.4) 2.3 (0.9 to 4.7) 2.3 (0.9 to 4.7) 1.7 (0.5 to 3.8) 1.3 (0.4 to 3.2)     Vomiting: Moderate 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0.4 (0.1 to 1.5) 0 (0.0 to 2.3) 0.3 (0.0 to 1.7) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0.7 (0.1 to 2.4) 0.3 (0.0 to 1.9) 0.7 (0.1 to 2.4) 0.3 (0.0 to 1.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Vomiting: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Vomiting: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     Diarrhea: Any 20.0 (7.7 to 38.6) 3.3 (0.1 to 17.2) 13.3 (3.8 to 30.7) 12.7 (9.9 to 16.0) 10.8 (6.4 to 16.7) 12.2 (8.8 to 16.3) 15.0 (3.2 to 37.9) 15.0 (3.2 to 37.9) 15.0 (3.2 to 37.9) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 4.4 (2.3 to 7.3) 5.7 (3.4 to 9.0) 8.0 (5.2 to 11.6) 10.3 (7.1 to 14.3) 9.0 (6.0 to 12.8) 6.4 (4.0 to 9.7)     Diarrhea: Mild 16.7 (5.6 to 34.7) 3.3 (0.1 to 17.2) 13.3 (3.8 to 30.7) 9.6 (7.1 to 12.6) 9.5 (5.4 to 15.2) 10.0 (6.9 to 13.8) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 3.4 (1.6 to 6.1) 3.7 (1.9 to 6.5) 6.6 (4.1 to 10.1) 9.0 (6.0 to 12.8) 6.0 (3.6 to 9.3) 5.8 (3.5 to 9.0)     Diarrhea: Moderate 3.3 (0.1 to 17.2) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 3.1 (1.8 to 5.1) 1.3 (0.2 to 4.5) 2.2 (0.9 to 4.5) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 1.0 (0.2 to 2.9) 2.0 (0.7 to 4.3) 0.7 (0.1 to 2.4) 1.3 (0.4 to 3.4) 1.7 (0.5 to 3.8) 0.6 (0.1 to 2.3)     Diarrhea: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0.7 (0.1 to 2.4) 0 (0.0 to 1.2) 1.3 (0.4 to 3.4) 0 (0.0 to 1.2)     Diarrhea: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     New or worsened muscle pain: Any 30.0 (14.7 to 49.4) 30.0 (14.7 to 49.4) 46.7 (28.3 to 65.7) 39.8 (35.4 to 44.3) 36.7 (29.2 to 44.7) 42.2 (36.7 to 47.8) 25.0 (8.7 to 49.1) 20.0 (5.7 to 43.7) 25.0 (8.7 to 49.1) 35.0 (15.4 to 59.2) 20.0 (5.7 to 43.7) 35.0 (15.4 to 59.2) 19.8 (15.4 to 24.8) 25.5 (20.7 to 30.8) 23.9 (19.2 to 29.1) 30.6 (25.4 to 36.1) 22.3 (17.7 to 27.4) 27.2 (22.4 to 32.5)     New or worsened muscle pain: Mild 6.7 (0.8 to 22.1) 10.0 (2.1 to 26.5) 23.3 (9.9 to 42.3) 18.3 (15.0 to 22.1) 20.3 (14.3 to 27.4) 17.8 (13.8 to 22.5) 10.0 (1.2 to 31.7) 15.0 (3.2 to 37.9) 10.0 (1.2 to 31.7) 25.0 (8.7 to 49.1) 5.0 (0.1 to 24.9) 25.0 (8.7 to 49.1) 11.7 (8.3 to 16.0) 10.1 (6.9 to 14.1) 11.6 (8.2 to 15.8) 12.6 (9.1 to 16.9) 13.3 (9.7 to 17.7) 14.1 (10.4 to 18.5)     New or worsened muscle pain: Moderate 23.3 (9.9 to 42.3) 20.0 (7.7 to 38.6) 23.3 (9.9 to 42.3) 21.3 (17.7 to 25.2) 15.8 (10.5 to 22.5) 22.2 (17.8 to 27.1) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 15.0 (3.2 to 37.9) 10.0 (1.2 to 31.7) 15.0 (3.2 to 37.9) 10.0 (1.2 to 31.7) 8.1 (5.2 to 11.7) 14.4 (10.6 to 18.9) 12.0 (8.5 to 16.2) 15.9 (12.0 to 20.6) 9.0 (6.0 to 12.8) 12.8 (9.3 to 17.0)     New or worsened muscle pain: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0.2 (0.0 to 1.2) 0.6 (0.0 to 3.5) 2.2 (0.9 to 4.5) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 1.0 (0.2 to 2.9) 0.3 (0.0 to 1.8) 2.0 (0.7 to 4.3) 0 (0.0 to 1.2) 0.3 (0.0 to 1.8)     New or worsened muscle pain: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)     New or worsened joint pain: Any 20.0 (7.7 to 38.6) 16.7 (5.6 to 34.7) 23.3 (9.9 to 42.3) 25.4 (21.6 to 29.6) 20.9 (14.8 to 28.1) 24.1 (19.5 to 29.1) 20.0 (5.7 to 43.7) 25.0 (8.7 to 49.1) 15.0 (3.2 to 37.9) 20.0 (5.7 to 43.7) 15.0 (3.2 to 37.9) 35.0 (15.4 to 59.2) 9.1 (6.1 to 12.9) 16.1 (12.1 to 20.8) 16.6 (12.6 to 21.3) 19.6 (15.3 to 24.5) 11.3 (8.0 to 15.4) 18.6 (14.4 to 23.4)     New or worsened joint pain: Mild 10.0 (2.1 to 26.5) 13.3 (3.8 to 30.7) 10.0 (2.1 to 26.5) 12.5 (9.7 to 15.8) 10.1 (5.9 to 15.9) 9.1 (6.2 to 12.8) 10.0 (1.2 to 31.7) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 20.0 (5.7 to 43.7) 5.0 (0.1 to 24.9) 15.0 (3.2 to 37.9) 5.4 (3.1 to 8.6) 9.7 (6.6 to 13.7) 9.3 (6.3 to 13.2) 8.3 (5.4 to 12.0) 7.6 (4.9 to 11.2) 10.3 (7.1 to 14.2)     New or worsened joint pain: Moderate 10.0 (2.1 to 26.5) 3.3 (0.1 to 17.2) 13.3 (3.8 to 30.7) 12.5 (9.7 to 15.8) 10.8 (6.4 to 16.7) 14.1 (10.4 to 18.4) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 10.0 (1.2 to 31.7) 20.0 (5.7 to 43.7) 3.7 (1.9 to 6.5) 6.0 (3.6 to 9.4) 7.3 (4.6 to 10.9) 11.0 (7.7 to 15.1) 3.7 (1.8 to 6.4) 8.0 (5.3 to 11.6)     New or worsened joint pain: Severe 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0.4 (0.1 to 1.5) 0 (0.0 to 2.3) 0.9 (0.2 to 2.7) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0.3 (0.0 to 1.9) 0 (0.0 to 1.2) 0.3 (0.0 to 1.8) 0 (0.0 to 1.2) 0.3 (0.0 to 1.8)     New or worsened joint pain: Grade 4 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 0.8) 0 (0.0 to 2.3) 0 (0.0 to 1.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2) 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: SSE: Percentage of Subjects With Systemic Events Within 7 Days After Study Vaccination Top of page

Primary: SSE: Percentage of Subjects Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination Top of page
End point title	SSE: Percentage of Subjects Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination [85] [86]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs within 1 month after study vaccination were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From study vaccination up to 1 Month after study vaccination
Notes [85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSE reporting groups only. [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 30 30 30 482 159 321 20 20 20 20 20 20 305 302 307 306 305 316 Units: Percentage of subjects     number (confidence interval 95%) 13.3 (3.8 to 30.7) 6.7 (0.8 to 22.1) 13.3 (3.8 to 30.7) 7.7 (5.5 to 10.4) 6.3 (3.1 to 11.3) 9.3 (6.4 to 13.1) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 15.0 (3.2 to 37.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 5.9 (3.5 to 9.2) 6.6 (4.1 to 10.0) 8.5 (5.6 to 12.2) 3.6 (1.8 to 6.3) 6.2 (3.8 to 9.6) 10.4 (7.3 to 14.4)
No statistical analyses for this end point

Primary: SSE: Percentage of Subjects Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination Top of page

Primary: SSE: Percentage of Subjects Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination Top of page
End point title	SSE: Percentage of Subjects Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination [87] [88]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From study vaccination up to 6 Months after study vaccination
Notes [87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSE reporting groups only. [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 60 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Sentinel Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Sentinel Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Sentinel Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 60 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 30 30 30 482 159 321 20 20 20 20 20 20 305 302 307 307 304 313 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 0.0) 0 (0.0 to 0.0) 0 (0.0 to 0.0) 0.6 (0.1 to 1.8) 1.3 (0.2 to 4.5) 0.9 (0.2 to 2.7) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 2.0 (0.7 to 4.2) 0.7 (0.1 to 2.4) 3.9 (2.0 to 6.7) 1.3 (0.4 to 3.3) 1.3 (0.4 to 3.3) 1.9 (0.7 to 4.1)
No statistical analyses for this end point

Primary: SSE: Percentage of Subjects Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination Top of page

Primary: SSE: Percentage of Subjects With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age Top of page
End point title	SSE: Percentage of Subjects With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age [89] [90]
End point description	Percentage of subjects with elevated troponin I levels before study vaccination were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. This endpoint was only analysed in the Sentinel Cohort.
End point type	Primary
End point timeframe	Before study vaccination
Notes [89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSE reporting groups only. [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg Number of subjects analysed 30 30 30 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6)
No statistical analyses for this end point

Primary: SSE: Percentage of Subjects With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age Top of page

Primary: SSE: Percentage of Subjects With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age Top of page
End point title	SSE: Percentage of Subjects With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age [91] [92]
End point description	Percentage of subjects with elevated troponin I levels before study vaccination were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention. This endpoint was only analysed in the Sentinel Cohort.
End point type	Primary
End point timeframe	3 days after study vaccination
Notes [91] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSE reporting groups only. [92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg Number of subjects analysed 30 30 30 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 11.6) 0 (0.0 to 11.6) 0 (0.0 to 11.6)
No statistical analyses for this end point

Primary: SSE: Percentage of Subjects With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age Top of page

Primary: SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron Strain Neutralizing Titers 1 Month After Study Vaccination- >55 Years of Age Top of page
End point title	SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron Strain Neutralizing Titers 1 Month After Study Vaccination- >55 Years of Age [93]
End point description	GMT of SARS-CoV-2 Omicron strain–neutralizing titers at 1 month after the study vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). 230 subjects were randomly selected from each group for immunogenicity analysis. Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and have no other important protocol deviations as determined by the clinician. Subjects without evidence of prior infection were included in the analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after study vaccination
Notes [93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 163 169 174 178 175 Units: Titer     geometric mean (confidence interval 95%) 455.8 (365.9 to 567.6) 1014.5 (825.6 to 1246.7) 1435.2 (1208.1 to 1704.8) 711.0 (588.3 to 859.2) 900.1 (726.3 to 1115.6)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on the student t distribution.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg
Number of subjects included in analysis	332
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.23
Confidence interval
level	95%
sides	2-sided
lower limit	1.65
upper limit	3
Statistical analysis title	BNT 30 mcg + BNT OMI 30 mcg vs BNT 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on the student t distribution.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Number of subjects included in analysis	338
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.97
Confidence interval
level	95%
sides	2-sided
lower limit	1.45
upper limit	2.68
Statistical analysis title	BNT 15 mcg + BNT OMI 15 mcg vs BNT 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on the student t distribution.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Number of subjects included in analysis	341
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.56
Confidence interval
level	95%
sides	2-sided
lower limit	1.17
upper limit	2.08
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on the student t distribution.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg
Number of subjects included in analysis	337
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	3.15
Confidence interval
level	95%
sides	2-sided
lower limit	2.38
upper limit	4.16

Primary: SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron Strain Neutralizing Titers 1 Month After Study Vaccination- >55 Years of Age Top of page

Primary: SSE: Percentages of Subjects With Seroresponse to the SARS-CoV-2 Omicron Strain at 1 Month After Study Vaccination- >55 Years of Age Top of page
End point title	SSE: Percentages of Subjects With Seroresponse to the SARS-CoV-2 Omicron Strain at 1 Month After Study Vaccination- >55 Years of Age [94]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), postvaccination measure of >= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 1 month was reported in this endpoint. 230 subjects were randomly selected from each group for immunogenicity analysis. Evaluable immunogenicity population included all eligible randomised/assigned subjects who received the study intervention to which they are randomised or assigned, have a valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination and had no other important protocol deviations as determined by the clinician. Subjects without evidence of prior infection were included in the analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	1 month after study vaccination
Notes [94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 149 163 166 169 162 Units: Percentages of subjects     number (confidence interval 95%) 57.0 (48.7 to 65.1) 76.7 (69.4 to 82.9) 86.1 (79.9 to 91.0) 71.6 (64.2 to 78.3) 67.9 (60.1 to 75.0)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	Difference in proportions, expressed as a percentage (BNT162b2 OMI [30 mcg] - BNT162b2 [30 μg]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 30 mcg
Number of subjects included in analysis	312
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Difference in percentages
Point estimate	19.6
Confidence interval
level	95%
sides	2-sided
lower limit	9.3
upper limit	29.7
Statistical analysis title	BNT 15 mcg + BNT OMI 15 mcg vs BNT 30 mcg
Statistical analysis description	Difference in proportions, expressed as a percentage (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 μg]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Number of subjects included in analysis	318
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Difference in percentages
Point estimate	14.6
Confidence interval
level	95%
sides	2-sided
lower limit	4
upper limit	24.9
Statistical analysis title	BNT 30 mcg + BNT OMI 30 mcg vs BNT 30 mcg
Statistical analysis description	Difference in proportions, expressed as a percentage (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 μg]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Number of subjects included in analysis	311
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Difference in Percentages
Point estimate	10.9
Confidence interval
level	95%
sides	2-sided
lower limit	0.1
upper limit	21.4
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	Difference in proportions, expressed as a percentage (BNT162b2 OMI [60 mcg] - BNT162b2 [30 μg]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT162b2 OMI 60 mcg
Number of subjects included in analysis	315
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Difference in Percentages
Point estimate	29.1
Confidence interval
level	95%
sides	2-sided
lower limit	19.4
upper limit	38.5

Primary: SSE: Percentages of Subjects With Seroresponse to the SARS-CoV-2 Omicron Strain at 1 Month After Study Vaccination- >55 Years of Age Top of page

Primary: SSF: Percentage of Subjects With Local Reactions Within 7 Days After Study Vaccination Top of page
End point title	SSF: Percentage of Subjects With Local Reactions Within 7 Days After Study Vaccination [95] [96]
End point description	Local reactions were recorded by subjects in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (emergency room [ER] visit or hospitalisation for severe pain). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (necrosis [swelling] or necrosis/exfoliative dermatitis [redness]). Grade 4 were classified by investigator or medically qualified person. Percentage of subjects reporting local reactions after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented. Safety population included all subjects receiving at least 1 dose of study intervention. Here, 'Number of Subjects Analysed (N)' = subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after the study vaccination
Notes [95] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 21 Units: Percentage of subjects number (confidence interval 95%)     Redness: Any 19.0 (5.4 to 41.9) 21.1 (6.1 to 45.6) 23.8 (8.2 to 47.2) 20.0 (5.7 to 43.7) 10.0 (1.2 to 31.7) 28.6 (11.3 to 52.2)     Redness: Mild 4.8 (0.1 to 23.8) 10.5 (1.3 to 33.1) 14.3 (3.0 to 36.3) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 23.8 (8.2 to 47.2)     Redness: Moderate 14.3 (3.0 to 36.3) 10.5 (1.3 to 33.1) 9.5 (1.2 to 30.4) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 4.8 (0.1 to 23.8)     Redness: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Redness: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Swelling: Any 14.3 (3.0 to 36.3) 15.8 (3.4 to 39.6) 14.3 (3.0 to 36.3) 15.0 (3.2 to 37.9) 15.0 (3.2 to 37.9) 28.6 (11.3 to 52.2)     Swelling: Mild 4.8 (0.1 to 23.8) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 23.8 (8.2 to 47.2)     Swelling: Moderate 9.5 (1.2 to 30.4) 10.5 (1.3 to 33.1) 9.5 (1.2 to 30.4) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 4.8 (0.1 to 23.8)     Swelling: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Swelling: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Pain at the injection site: Any 71.4 (47.8 to 88.7) 94.7 (74.0 to 99.9) 90.5 (69.6 to 98.8) 80.0 (56.3 to 94.3) 75.0 (50.9 to 91.3) 90.5 (69.6 to 98.8)     Pain at the injection site: Mild 52.4 (29.8 to 74.3) 52.6 (28.9 to 75.6) 66.7 (43.0 to 85.4) 45.0 (23.1 to 68.5) 55.0 (31.5 to 76.9) 57.1 (34.0 to 78.2)     Pain at the injection site: Moderate 19.0 (5.4 to 41.9) 36.8 (16.3 to 61.6) 19.0 (5.4 to 41.9) 35.0 (15.4 to 59.2) 20.0 (5.7 to 43.7) 33.3 (14.6 to 57.0)     Pain at the injection site: Severe 0 (0.0 to 16.1) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Pain at the injection site: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)
No statistical analyses for this end point

Primary: SSF: Percentage of Subjects With Local Reactions Within 7 Days After Study Vaccination Top of page

Primary: SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination Top of page
End point title	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination [97] [98]
End point description	GMT of SARS-CoV-2 Omicron BA.1 strain neutralizing titers before vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination.
End point type	Primary
End point timeframe	Before vaccination (pre-vaccination)
Notes [97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 21 Units: Titer     geometric mean (confidence interval 95%) 41.7 (22.4 to 77.4) 33.2 (17.6 to 62.6) 32.0 (17.0 to 60.1) 36.8 (17.5 to 77.1) 78.8 (29.3 to 211.6) 21.5 (14.2 to 32.7)
No statistical analyses for this end point

Primary: SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination Top of page

Primary: SSF: Percentage of Subjects With Systemic Events Within 7 Days After Study Vaccination Top of page
End point title	SSF: Percentage of Subjects With Systemic Events Within 7 Days After Study Vaccination [99] [100]
End point description	Systemic events recorded in e-diary. Fever:oral temperature greater than or equal to 38.0 deg C and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C & >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalisation). Vomiting: mild: 1-2 times in 24 h, moderate: > 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalisation for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalisation for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method. Safety population= all subjects receiving at least 1 dose of study intervention. N=subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 up to Day 7 after the study vaccination
Notes [99] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 21 Units: Percentage of Subjects number (confidence interval 95%)     Fever: >= 38.0 deg C 9.5 (1.2 to 30.4) 10.5 (1.3 to 33.1) 9.5 (1.2 to 30.4) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 4.8 (0.1 to 23.8)     Fever: >= 38.0 deg C to 38.4 deg C 9.5 (1.2 to 30.4) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 4.8 (0.1 to 23.8)     Fever: >38.4 deg C to 38.9 deg C 0 (0.0 to 16.1) 5.3 (0.1 to 26.0) 0 (0.0 to 16.1) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 0 (0.0 to 16.1)     Fever: >38.9 deg C to 40.0 deg C 0 (0.0 to 16.1) 0 (0.0 to 17.6) 4.8 (0.1 to 23.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Fever: >40.0 deg C 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Fatigue: Any 47.6 (25.7 to 70.2) 36.8 (16.3 to 61.6) 42.9 (21.8 to 66.0) 55.0 (31.5 to 76.9) 50.0 (27.2 to 72.8) 57.1 (34.0 to 78.2)     Fatigue: Mild 9.5 (1.2 to 30.4) 10.5 (1.3 to 33.1) 9.5 (1.2 to 30.4) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 23.8 (8.5 to 47.2)     Fatigue: Moderate 23.8 (8.2 to 47.2) 21.1 (6.1 to 45.6) 28.6 (11.3 to 52.2) 35.0 (15.4 to 59.2) 40.0 (19.1 to 63.9) 33.3 (14.6 to 57.0)     Fatigue: Severe 14.3 (3.0 to 36.3) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 10.0 (1.2 to 31.7) 5.0 (0.1 to 24.9) 0 (0.0 to 16.1)     Fatigue: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Headache: Any 28.6 (11.3 to 52.2) 26.3 (9.1 to 51.2) 23.8 (8.2 to 47.2) 55.0 (31.5 to 76.9) 35.0 (15.4 to 59.2) 38.1 (18.1 to 61.6)     Headache: Mild 19.0 (5.4 to 41.9) 15.8 (3.4 to 39.6) 4.8 (0.1 to 23.8) 15.0 (3.2 to 37.9) 20.0 (5.7 to 43.7) 19.0 (5.4 to 41.9)     Headache: Moderate 9.5 (1.2 to 30.4) 10.5 (1.3 to 33.1) 14.3 (3.0 to 36.3) 40.0 (19.1 to 63.9) 15.0 (3.2 to 37.9) 19.0 (5.4 to 41.9)     Headache: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 4.8 (0.1 to 23.8) 0 (0.0 to 16.8) 0 (0.0 to 16.7) 0 (0.0 to 16.1)     Headache: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Chills: Any 14.3 (3.0 to 36.3) 15.8 (3.4 to 39.6) 23.8 (8.2 to 47.2) 25.0 (8.7 to 49.1) 5.0 (0.1 to 24.9) 14.3 (3.0 to 36.3)     Chills: Mild 4.8 (0.1 to 23.8) 10.5 (1.3 to 33.1) 14.3 (3.0 to 36.3) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 9.5 (1.2 to 30.4)     Chills: Moderate 9.5 (1.2 to 30.4) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 5.0 (0.1 to 24.9) 5.0 (0.1 to 24.9) 4.8 (0.1 to 23.8)     Chills: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 4.8 (0.1 to 23.8) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Chills: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Vomiting: Any 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Vomiting: Mild 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Vomiting: Moderate 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Vomiting: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Vomiting: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Diarrhea: Any 14.3 (3.0 to 36.3) 5.3 (0.1 to 26.0) 9.5 (1.2 to 30.4) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Diarrhea: Mild 9.5 (1.2 to 30.4) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Diarrhea: Moderate 0 (0.0 to 16.1) 0 (0.0 to 17.6) 4.8 (0.1 to 23.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Diarrhea: Severe 4.8 (0.1 to 23.8) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     Diarrhea: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     New or worsened muscle pain: Any 19.0 (5.4 to 41.9) 42.1 (20.3 to 66.5) 23.8 (8.2 to 47.2) 30.0 (11.9 to 54.3) 25.0 (8.7 to 49.1) 28.6 (11.3 to 52.2)     New or worsened muscle pain: Mild 4.8 (0.1 to 23.8) 10.5 (1.3 to 33.1) 14.3 (3.0 to 36.3) 10.0 (1.2 to 31.9) 15.0 (3.2 to 37.9) 23.8 (8.2 to 47.2)     New or worsened muscle pain: Moderate 14.3 (3.0 to 36.3) 31.6 (12.6 to 56.6) 4.8 (0.1 to 23.8) 20.0 (5.7 to 43.7) 10.0 (1.2 to 31.7) 4.8 (0.1 to 23.8)     New or worsened muscle pain: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 4.8 (0.1 to 23.8) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     New or worsened muscle pain: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     New or worsened joint pain: Any 14.3 (3.0 to 36.3) 15.8 (3.4 to 39.6) 14.3 (3.0 to 36.3) 20.0 (5.7 to 43.7) 10.0 (1.2 to 31.7) 9.5 (1.2 to 30.4)     New or worsened joint pain: Mild 4.8 (0.1 to 23.8) 10.5 (1.3 to 33.1) 9.5 (1.2 to 30.4) 10.0 (1.2 to 31.7) 10.0 (1.2 to 31.7) 4.8 (0.1 to 23.8)     New or worsened joint pain: Moderate 9.5 (1.2 to 30.4) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 10.0 (1.2 to 31.7) 0 (0.0 to 16.8) 4.8 (0.1 to 23.8)     New or worsened joint pain: Severe 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)     New or worsened joint pain: Grade 4 0 (0.0 to 16.1) 0 (0.0 to 17.6) 0 (0.0 to 16.1) 0 (0.0 to 16.8) 0 (0.0 to 16.8) 0 (0.0 to 16.1)
No statistical analyses for this end point

Primary: SSF: Percentage of Subjects With Systemic Events Within 7 Days After Study Vaccination Top of page

Primary: SSF: Percentage of Subjects Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination Top of page
End point title	SSF: Percentage of Subjects Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination [101] [102]
End point description	An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs within 1 month after study vaccination were reported in this endpoint. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From study vaccination up to 1 Month after study vaccination
Notes [101] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 21 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 16.1) 10.5 (1.3 to 33.1) 9.5 (1.2 to 30.4) 5.0 (0.1 to 24.9) 10.0 (1.2 to 31.7) 0 (0.0 to 16.1)
No statistical analyses for this end point

Primary: SSF: Percentage of Subjects Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination Top of page

Primary: SSF: Percentage of Subjects Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination Top of page
End point title	SSF: Percentage of Subjects Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination [103] [104]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From study vaccination up to 6 Months after study vaccination
Notes [103] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 21 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 16.1) 5.3 (0.1 to 26.0) 4.8 (0.1 to 23.8) 0 (0.0 to 16.8) 5.0 (0.1 to 24.9) 0 (0.0 to 16.1)
No statistical analyses for this end point

Primary: SSF: Percentage of Subjects Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination Top of page

Primary: SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination Top of page
End point title	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination [105] [106]
End point description	GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers before vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Before vaccination (pre-vaccination)
Notes [105] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 21 Units: Titer     geometric mean (confidence interval 95%) 27.1 (16.8 to 43.7) 18.0 (12.1 to 26.7) 20.2 (12.6 to 32.3) 23.4 (13.9 to 39.4) 42.2 (19.6 to 91.1) 15.0 (11.8 to 19.1)
No statistical analyses for this end point

Primary: SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination Top of page

Primary: SSF: GMTs of SARS-CoV-2 Reference-Strain–Neutralizing Titers Before Vaccination Top of page
End point title	SSF: GMTs of SARS-CoV-2 Reference-Strain–Neutralizing Titers Before Vaccination [107] [108]
End point description	GMT of SARS-CoV-2 reference-strain-neutralizing titers before vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination.
End point type	Primary
End point timeframe	Before vaccination (pre-vaccination)
Notes [107] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [108] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 21 Units: Titer     geometric mean (confidence interval 95%) 541.1 (345.1 to 848.3) 382.4 (176.3 to 829.3) 437.5 (244.0 to 784.2) 315.2 (188.0 to 528.4) 803.4 (347.8 to 1855.8) 256.0 (135.1 to 485.0)
No statistical analyses for this end point

Primary: SSF: GMTs of SARS-CoV-2 Reference-Strain–Neutralizing Titers Before Vaccination Top of page

Primary: SSF: GMT and Geometric Mean Ratios (GMR) of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Day 7 Top of page
End point title	SSF: GMT and Geometric Mean Ratios (GMR) of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Day 7 [109]
End point description	GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at Day 7 were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 7
Notes [109] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 146.1 (102.5 to 208.2) 101.6 (48.6 to 212.6) 217.1 (97.8 to 481.9) 315.2 (164.6 to 603.5) 337.8 (133.8 to 852.7) 222.9 (125.7 to 395.1)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 OMI 30 mcg v SSF: BNT162b2 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.78
Confidence interval
level	95%
sides	2-sided
lower limit	0.93
upper limit	3.43
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 60 mcg v SSF: BNT162b2 30 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.79
Confidence interval
level	95%
sides	2-sided
lower limit	0.4
upper limit	1.56
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg]- BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.49
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	2.89
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.33
Confidence interval
level	95%
sides	2-sided
lower limit	1.2
upper limit	4.53
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.35
Confidence interval
level	95%
sides	2-sided
lower limit	1.22
upper limit	4.55

Primary: SSF: GMT and Geometric Mean Ratios (GMR) of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Day 7 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Day 7 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Day 7 [110]
End point description	GMTs of SARS-CoV-2 reference strain neutralizing titers at Day 7 were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 7
Notes [110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 1917.2 (1153.8 to 3185.7) 1241.4 (624.3 to 2468.6) 1472.3 (855.4 to 2534.0) 1499.2 (838.6 to 2680.4) 2702.4 (1419.7 to 5143.8) 1845.8 (1087.4 to 3133.1)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.76
Confidence interval
level	95%
sides	2-sided
lower limit	0.4
upper limit	1.42
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.35
Confidence interval
level	95%
sides	2-sided
lower limit	0.73
upper limit	2.5
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.13
Confidence interval
level	95%
sides	2-sided
lower limit	0.61
upper limit	2.09
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.86
Confidence interval
level	95%
sides	2-sided
lower limit	0.47
upper limit	1.58
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.06
Confidence interval
level	95%
sides	2-sided
lower limit	0.57
upper limit	1.95

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Day 7 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7 [111]
End point description	GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at Day 7 were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 7
Notes [111] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 17 21 20 20 21 Units: Titer     geometric mean (confidence interval 95%) 75.5 (52.7 to 108.0) 56.6 (32.1 to 99.8) 73.0 (38.7 to 137.9) 76.1 (46.0 to 125.9) 123.6 (63.8 to 239.5) 70.7 (48.5 to 103.0)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.22
Confidence interval
level	95%
sides	2-sided
lower limit	0.77
upper limit	1.93
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	38
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.95
Confidence interval
level	95%
sides	2-sided
lower limit	0.58
upper limit	1.56
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.16
Confidence interval
level	95%
sides	2-sided
lower limit	0.73
upper limit	1.84
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.13
Confidence interval
level	95%
sides	2-sided
lower limit	0.71
upper limit	1.8
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.49
Confidence interval
level	95%
sides	2-sided
lower limit	0.94
upper limit	2.37

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 1 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 1 [112]
End point description	GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 1 month were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 1
Notes [112] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 20 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 420.0 (252.2 to 699.5) 188.1 (88.9 to 398.2) 699.4 (398.9 to 1226.4) 675.6 (343.2 to 1329.8) 1024.0 (509.4 to 2058.3) 477.7 (236.0 to 967.1)
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.84
Confidence interval
level	95%
sides	2-sided
lower limit	0.9
upper limit	3.76
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.49
Confidence interval
level	95%
sides	2-sided
lower limit	0.24
upper limit	1.03
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.75
Confidence interval
level	95%
sides	2-sided
lower limit	0.85
upper limit	3.59
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.56
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	3.2
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.72
Confidence interval
level	95%
sides	2-sided
lower limit	0.84
upper limit	3.5

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 1 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 1 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 1 [113]
End point description	GMTs of SARS-CoV-2 reference strain neutralizing titers at 1 month were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 1
Notes [113] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 20 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 4674.1 (3112.1 to 7020.2) 2048.4 (1007.8 to 4163.7) 3327.0 (1867.6 to 5926.9) 3565.8 (1992.1 to 6382.7) 5404.7 (3359.8 to 8694.1) 2521.4 (1388.9 to 4577.4)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.5
Confidence interval
level	95%
sides	2-sided
lower limit	0.26
upper limit	0.95
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.76
Confidence interval
level	95%
sides	2-sided
lower limit	0.41
upper limit	1.43
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.98
Confidence interval
level	95%
sides	2-sided
lower limit	0.52
upper limit	1.84
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.96
Confidence interval
level	95%
sides	2-sided
lower limit	0.51
upper limit	1.8
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.71
Confidence interval
level	95%
sides	2-sided
lower limit	0.38
upper limit	1.34

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 1 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 1 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 1 [114]
End point description	GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 1 month were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 1
Notes [114] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 19 21 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 157.6 (94.0 to 264.2) 85.7 (52.5 to 139.8) 151.0 (72.6 to 314.1) 230.7 (140.0 to 379.2) 284.0 (134.7 to 599.1) 147.0 (86.3 to 250.4)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.72
Confidence interval
level	95%
sides	2-sided
lower limit	0.38
upper limit	1.37
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.19
Confidence interval
level	95%
sides	2-sided
lower limit	0.65
upper limit	2.21
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.42
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	2.67
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.28
Confidence interval
level	95%
sides	2-sided
lower limit	0.68
upper limit	2.39
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.63
Confidence interval
level	95%
sides	2-sided
lower limit	0.88
upper limit	3.02

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 1 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 3 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 3 [115]
End point description	GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 3 months were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 3
Notes [115] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 20 19 20 19 Units: Titer     geometric mean (confidence interval 95%) 247.3 (119.7 to 510.7) 118.5 (54.6 to 257.1) 461.4 (203.8 to 1044.7) 711.0 (388.8 to 1300.1) 512.0 (246.9 to 1061.6) 285.6 (132.8 to 614.1)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	38
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.52
Confidence interval
level	95%
sides	2-sided
lower limit	0.21
upper limit	1.25
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.07
Confidence interval
level	95%
sides	2-sided
lower limit	0.88
upper limit	4.88
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio
Point estimate	1.53
Confidence interval
level	95%
sides	2-sided
lower limit	0.64
upper limit	3.67
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.52
Confidence interval
level	95%
sides	2-sided
lower limit	0.64
upper limit	3.62
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.96
Confidence interval
level	95%
sides	2-sided
lower limit	1.24
upper limit	7.06

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 3 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 3 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 3 [116]
End point description	GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 3 months were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 3
Notes [116] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 19 21 19 19 21 Units: Titer     geometric mean (confidence interval 95%) 222.9 (123.3 to 402.7) 132.8 (63.7 to 276.7) 322.5 (147.6 to 704.6) 458.9 (206.8 to 1018.6) 296.2 (143.2 to 612.6) 141.3 (86.4 to 231.1)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.75
Confidence interval
level	95%
sides	2-sided
lower limit	0.32
upper limit	1.76
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.69
Confidence interval
level	95%
sides	2-sided
lower limit	0.74
upper limit	3.85
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.89
Confidence interval
level	95%
sides	2-sided
lower limit	0.39
upper limit	2.04
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1
Confidence interval
level	95%
sides	2-sided
lower limit	0.43
upper limit	2.33
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.12
Confidence interval
level	95%
sides	2-sided
lower limit	0.92
upper limit	4.91

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 3 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 3 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 3 [117]
End point description	GMTs of SARS-CoV-2 reference strain neutralizing titers at 3 months were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 3
Notes [117] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 20 19 20 19 Units: Titer     geometric mean (confidence interval 95%) 2896.3 (1738.8 to 4824.3) 1290.2 (675.2 to 2465.3) 2610.3 (1265.9 to 5382.4) 2949.6 (1550.2 to 5612.3) 2610.3 (1506.5 to 4522.8) 1474.8 (815.0 to 2668.9)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	38
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.52
Confidence interval
level	95%
sides	2-sided
lower limit	0.25
upper limit	1.09
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1
Confidence interval
level	95%
sides	2-sided
lower limit	0.49
upper limit	2.04
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.66
Confidence interval
level	95%
sides	2-sided
lower limit	0.32
upper limit	1.36
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.78
Confidence interval
level	95%
sides	2-sided
lower limit	0.38
upper limit	1.59
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	39
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.29
Confidence interval
level	95%
sides	2-sided
lower limit	0.63
upper limit	2.68

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 3 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 6 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 6 [118]
End point description	GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 6 months were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 6
Notes [118] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 239.6 (98.8 to 581.4) 229.5 (68.7 to 766.4) 1058.4 (490.3 to 2284.6) 1722.2 (844.3 to 3512.9) 588.1 (280.3 to 1234.2) 284.0 (131.8 to 612.4)
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.28
Confidence interval
level	95%
sides	2-sided
lower limit	0.41
upper limit	4.03
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.99
Confidence interval
level	95%
sides	2-sided
lower limit	0.31
upper limit	3.12
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.26
Confidence interval
level	95%
sides	2-sided
lower limit	0.72
upper limit	7.1
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	7.3
Confidence interval
level	95%
sides	2-sided
lower limit	2.34
upper limit	22.76
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	4.57
Confidence interval
level	95%
sides	2-sided
lower limit	1.49
upper limit	14.07

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers at Month 6 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 6 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 6 [119]
End point description	GMTs of SARS-CoV-2 reference strain neutralizing titers at 6 months were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 6
Notes [119] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 1424.5 (667.9 to 3037.9) 1371.0 (508.5 to 3696.4) 2756.4 (1328.0 to 5721.4) 3956.5 (2256.3 to 6937.8) 2702.4 (1457.6 to 5010.0) 1097.5 (555.3 to 2169.1)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.01
Confidence interval
level	95%
sides	2-sided
lower limit	0.38
upper limit	2.7
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.99
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	5.2
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.84
Confidence interval
level	95%
sides	2-sided
lower limit	0.32
upper limit	2.24
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.8
Confidence interval
level	95%
sides	2-sided
lower limit	0.68
upper limit	4.75
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.99
Confidence interval
level	95%
sides	2-sided
lower limit	1.13
upper limit	7.94

Primary: SSF: GMT and GMR of SARS-CoV-2 Reference-Strain–Neutralizing Titers at Month 6 Top of page

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 6 Top of page
End point title	SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 6 [120]
End point description	GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 6 months were reported in this endpoint in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section. All-available immunogenicity population included all randomised subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 6
Notes [120] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Titer     geometric mean (confidence interval 95%) 203.2 (85.5 to 483.1) 265.5 (75.9 to 928.9) 645.1 (281.1 to 1480.5) 1305.2 (601.1 to 2834.1) 430.5 (204.7 to 905.4) 187.4 (80.5 to 436.3)
Statistical analysis title	BNT162b2 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 60 mcg
Number of subjects included in analysis	40
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.5
Confidence interval
level	95%
sides	2-sided
lower limit	0.44
upper limit	5.12
Statistical analysis title	BNT162b2 OMI 30 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 30 mcg
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	3.22
Confidence interval
level	95%
sides	2-sided
lower limit	0.99
upper limit	10.46
Statistical analysis title	BNT162b2 30 + BNT162b2 OMI 30 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.95
Confidence interval
level	95%
sides	2-sided
lower limit	0.28
upper limit	3.17
Statistical analysis title	BNT162b2 15 + BNT162b2 OMI 15 vs BNT162b2 30
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	2.08
Confidence interval
level	95%
sides	2-sided
lower limit	0.63
upper limit	6.89
Statistical analysis title	BNT162b2 OMI 60 mcg vs BNT162b2 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI [60 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.
Comparison groups	SSF: BNT162b2 30 mcg v SSF: BNT162b2 OMI 60 mcg
Number of subjects included in analysis	41
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	6.46
Confidence interval
level	95%
sides	2-sided
lower limit	1.96
upper limit	21.27

Primary: SSF: GMT and GMR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers at Month 6 Top of page

Primary: SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination Top of page
End point title	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination [121] [122]
End point description	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to Day 7 was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to Day 7 after vaccination
Notes [121] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [122] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 3.5 (2.1 to 5.8) 2.9 (1.6 to 5.4) 6.8 (4.3 to 10.7) 8.6 (5.1 to 14.3) 4.3 (2.0 to 9.1) 9.8 (6.9 to 14.0)
No statistical analyses for this end point

Primary: SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination [123] [124]
End point description	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to Day 7 was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to Day 7 after vaccination
Notes [123] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [124] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 16 21 20 20 21 Units: Fold rise     geometric mean (confidence interval 95%) 2.8 (2.1 to 3.7) 2.8 (1.8 to 4.4) 3.6 (2.5 to 5.2) 3.2 (2.2 to 4.8) 2.9 (1.9 to 4.4) 4.7 (3.4 to 6.5)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination [125] [126]
End point description	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 1 month was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 1 month after vaccination
Notes [125] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [126] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 20 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 10.1 (5.5 to 18.4) 5.4 (2.6 to 11.4) 20.4 (11.8 to 35.3) 18.4 (9.5 to 35.6) 13.0 (6.7 to 25.1) 21.1 (11.5 to 38.8)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination [127] [128]
End point description	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to Day 7 was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to Day 7 after vaccination
Notes [127] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [128] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 3.5 (2.5 to 5.0) 3.1 (1.8 to 5.2) 3.4 (2.2 to 5.1) 4.8 (3.0 to 7.5) 3.4 (1.4 to 8.1) 6.3 (3.9 to 10.2)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to Day 7 After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination [129] [130]
End point description	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 1 month was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 1 month after vaccination
Notes [129] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [130] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 21 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 5.9 (3.8 to 9.1) 4.7 (3.1 to 7.1) 7.5 (4.6 to 12.3) 9.8 (7.3 to 13.3) 6.7 (3.5 to 13.0) 9.5 (6.0 to 15.2)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination [131] [132]
End point description	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 1 month was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 1 month after vaccination
Notes [131] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [132] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 20 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 8.6 (5.5 to 13.6) 5.0 (2.5 to 10.0) 7.2 (4.7 to 10.9) 11.3 (6.2 to 20.8) 6.7 (3.7 to 12.1) 8.6 (4.1 to 17.8)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination [133] [134]
End point description	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 3 months was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 3 months after vaccination
Notes [133] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [134] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 20 19 20 19 Units: Fold rise     geometric mean (confidence interval 95%) 5.0 (2.9 to 8.5) 3.2 (1.6 to 6.3) 5.6 (2.6 to 11.9) 8.6 (4.3 to 17.2) 3.2 (1.8 to 5.8) 4.5 (2.4 to 8.2)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination [135] [136]
End point description	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 3 months was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 3 months after vaccination
Notes [135] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [136] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 20 19 20 19 Units: Fold rise     geometric mean (confidence interval 95%) 5.9 (2.7 to 12.8) 3.3 (1.4 to 7.5) 13.5 (6.0 to 30.0) 17.9 (8.7 to 36.5) 6.5 (3.2 to 13.1) 12.0 (6.4 to 22.3)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination [137] [138]
End point description	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 3 months was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 3 months after vaccination
Notes [137] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [138] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 21 19 19 21 Units: Fold rise     geometric mean (confidence interval 95%) 8.6 (4.3 to 16.9) 7.4 (3.7 to 14.9) 16.0 (7.5 to 34.0) 18.5 (9.2 to 37.3) 7.2 (4.1 to 12.7) 9.4 (5.9 to 15.2)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination [139] [140]
End point description	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 6 months was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 6 months after vaccination
Notes [139] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [140] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 5.8 (2.2 to 15.0) 6.9 (1.6 to 30.4) 33.1 (13.7 to 79.6) 46.9 (17.6 to 124.7) 7.5 (2.4 to 22.8) 12.6 (5.8 to 27.3)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination [141] [142]
End point description	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 6 months was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 6 months after vaccination
Notes [141] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [142] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 2.6 (1.1 to 6.1) 3.6 (1.0 to 12.7) 6.3 (2.6 to 15.2) 12.6 (6.0 to 26.1) 3.4 (1.3 to 8.9) 3.9 (1.8 to 8.2)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Reference-Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination Top of page

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination Top of page
End point title	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination [143] [144]
End point description	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 6 months was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	From before the study vaccination to 6 months after vaccination
Notes [143] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [144] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Fold rise     geometric mean (confidence interval 95%) 7.5 (2.8 to 20.2) 16.6 (4.1 to 66.8) 32.0 (12.7 to 80.7) 55.7 (22.2 to 140.0) 10.2 (3.7 to 28.0) 13.0 (5.4 to 31.4)
No statistical analyses for this end point

Primary: SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain–Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7 [145] [146]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse on Day 7 was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 7
Notes [145] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [146] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 52.4 (29.8 to 74.3) 55.6 (30.8 to 78.5) 61.9 (38.4 to 81.9) 80.0 (56.3 to 94.3) 55.0 (31.5 to 76.9) 80.0 (56.3 to 94.3)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7 [147] [148]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse on Day 7 was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 7
Notes [147] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [148] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 52.4 (29.8 to 74.3) 44.4 (21.5 to 69.2) 71.4 (47.8 to 88.7) 85.0 (62.1 to 96.8) 55.0 (31.5 to 76.9) 90.0 (68.3 to 98.8)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7 [149] [150]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse on Day 7 was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 7
Notes [149] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [150] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 16 21 20 20 21 Units: Percentage of subjects     number (confidence interval 95%) 33.3 (14.6 to 57.0) 43.8 (19.8 to 70.1) 42.9 (21.8 to 66.0) 40.0 (19.1 to 63.9) 40.0 (19.1 to 63.9) 61.9 (38.4 to 81.9)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1 [151] [152]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 1 month was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 1
Notes [151] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [152] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 20 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 85.7 (63.7 to 97.0) 61.1 (35.7 to 82.7) 90.0 (68.3 to 98.8) 85.0 (62.1 to 96.8) 90.0 (68.3 to 98.8) 85.0 (62.1 to 96.8)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1 [153] [154]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 1 month was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 1
Notes [153] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [154] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 20 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 81.0 (58.1 to 94.6) 61.1 (35.7 to 82.7) 85.0 (62.1 to 96.8) 85.0 (62.1 to 96.8) 70.0 (45.7 to 88.1) 75.0 (50.9 to 91.3)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1 [155] [156]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 1 month was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 1
Notes [155] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [156] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 21 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 75.0 (50.9 to 91.3) 61.1 (35.7 to 82.7) 66.7 (43.0 to 85.4) 95.0 (75.1 to 99.9) 80.0 (56.3 to 94.3) 85.0 (62.1 to 96.8)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3 [157] [158]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 3 months was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 3
Notes [157] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [158] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 20 19 20 19 Units: Percentage of subjects     number (confidence interval 95%) 65.0 (40.8 to 84.6) 50.0 (26.0 to 74.0) 75.0 (50.9 to 91.3) 84.2 (60.4 to 96.6) 70.0 (45.7 to 88.1) 89.5 (66.9 to 98.7)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3 [159] [160]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 3 months was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 3
Notes [159] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [160] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 20 19 20 19 Units: Percentage of subjects     number (confidence interval 95%) 65.0 (40.8 to 84.6) 55.6 (30.8 to 78.5) 65.0 (40.8 to 84.6) 78.9 (54.4 to 93.9) 55.0 (31.5 to 76.9) 63.2 (38.4 to 83.7)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3 [161] [162]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 3 months was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 3
Notes [161] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [162] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 20 18 21 19 19 21 Units: Percentage of subjects     number (confidence interval 95%) 75.0 (50.9 to 91.3) 61.1 (35.7 to 82.7) 85.7 (63.7 to 97.0) 84.2 (60.4 to 96.6) 63.2 (38.4 to 83.7) 85.7 (63.7 to 97.0)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6 [163] [164]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 6 months was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 6
Notes [163] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [164] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 42.9 (21.8 to 66.0) 47.4 (24.4 to 71.1) 85.7 (63.7 to 97.0) 90.0 (68.3 to 98.8) 65.0 (40.8 to 84.6) 85.0 (62.1 to 96.8)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6 [165] [166]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 6 months was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 6
Notes [165] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [166] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 19 21 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 42.9 (21.8 to 66.0) 42.1 (20.3 to 66.5) 61.9 (38.4 to 81.9) 85.0 (62.1 to 96.8) 55.0 (31.5 to 76.9) 50.0 (27.2 to 72.8)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6 Top of page

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6 Top of page
End point title	SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6 [167] [168]
End point description	Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse at 6 months was reported in this endpoint. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Primary
End point timeframe	Month 6
Notes [167] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This analysis was planned to be analysed in SSF reporting groups only. [168] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSF reporting groups only.
End point values SSF: BNT162b2 30 mcg SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Number of subjects analysed 21 18 21 20 20 20 Units: Percentage of subjects     number (confidence interval 95%) 52.4 (29.8 to 74.3) 50.0 (26.0 to 74.0) 85.7 (63.7 to 97.0) 90.0 (68.3 to 98.8) 70.0 (45.7 to 88.1) 75.0 (50.9 to 91.3)
No statistical analyses for this end point

Primary: SSF: Percentages of Subjects With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6 Top of page

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population Top of page
End point title	SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population [169]
End point description	Occurrence of first severe COVID-19 infection based on FDA definition after booster dose without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate greater than or equal to [≥]30 breaths per minute, heart rate ≥125 beats per minute, oxygen saturation less than or equal to [≤]93% on room air at sea level, or Horovitz quotient <300 mmHg); 2) respiratory failure (needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic blood pressure [BP] <90 mmHg, diastolic BP <60 mmHg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death. Evaluable efficacy population assessed. HIV positive subjects were excluded from this analysis. Here, 'N'=subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	From 7 Days after booster vaccination (Surveillance time [1000 person-year]: BNT162b2- 1.105, Placebo- 0.951)
Notes [169] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4639 4601 Units: Number of cases     number (not applicable) 0 2
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Comparison groups	SSA: BNT162b2 30 mcg: Blinded and Open Label Period v SSA: Placebo: Blinded Period
Number of subjects included in analysis	9240
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Adjusted Surveillance Time
Point estimate	100
Confidence interval
level	95%
sides	2-sided
lower limit	-358.6
upper limit	100

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population Top of page

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population Top of page
End point title	SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population [170]
End point description	Occurrence of first severe COVID-19 infection based on FDA definition after booster dose with and without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, oxygen saturation ≤93% on room air at sea level, or Horovitz quotient <300 mm Hg); 2) respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic BP <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death. Evaluable efficacy population assessed. HIV positive subjects were excluded from this analysis. Here, 'N'=subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	From 7 Days after booster vaccination (Surveillance time [1000 person-year]: BNT162b2- 1.182, Placebo- 1.011)
Notes [170] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4911 4861 Units: Number of cases     number (not applicable) 0 2
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	SSA: BNT162b2 30 mcg: Blinded and Open Label Period v SSA: Placebo: Blinded Period
Number of subjects included in analysis	9772
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Adjusted Surveillance Time
Point estimate	100
Confidence interval
level	95%
sides	2-sided
lower limit	-355.5
upper limit	100

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population Top of page

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection Top of page
End point title	SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection [171]
End point description	Occurrence of first severe COVID-19 infection based on CDC definition after booster dose with and without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 AND presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death. Evaluable efficacy population included eligible randomized subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	From 7 Days after booster vaccination
Notes [171] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4977 4942 Units: Number of cases     number (not applicable) 0 0
No statistical analyses for this end point

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection Top of page

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection Top of page
End point title	SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection [172]
End point description	Occurrence of first severe COVID-19 infection based on CDC definition after booster dose without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 and presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death. Evaluable efficacy population included eligible randomized subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	From 7 Days after booster vaccination
Notes [172] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSA reporting groups only.
End point values SSA: BNT162b2 30 mcg: Blinded and Open Label Period SSA: Placebo: Blinded Period Number of subjects analysed 4689 4664 Units: Number of cases     number (not applicable) 0 0
No statistical analyses for this end point

Secondary: SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection Top of page

Secondary: SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster (Third) Dose Top of page
End point title	SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster (Third) Dose [173]
End point description	GMT of SARS-CoV-2 Omicron BA.1- neutralizing titers at baseline and 7 days after the booster (third) dose was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). This analysis is based on the first approximately 100 subjects. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint and 'n' signifies subjects evaluable at specified timepoint.
End point type	Secondary
End point timeframe	At baseline and 7 days after booster (third) dose
Notes [173] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 52 47 Units: Titer geometric mean (confidence interval 95%)     Baseline; n= 52, 47 68.2 (39.1 to 119.1) 131.1 (68.7 to 250.7)     Day 7; n= 49, 47 1356.4 (970.1 to 1896.4) 2655.7 (2046.7 to 3445.9)
No statistical analyses for this end point

Secondary: SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster (Third) Dose Top of page

Secondary: SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster (Third) Dose Top of page
End point title	SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster (Third) Dose [174]
End point description	GMT of SARS-CoV-2 reference-strain neutralizing titers at baseline and 7 days after the booster (third) dose was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). This analysis is based on the first approximately 100 subjects. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	At baseline and 7 days after the booster (third) dose
Notes [174] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 52 47 Units: Titer geometric mean (confidence interval 95%)     Baseline 1846.7 (1232.1 to 2767.9) 2230.4 (1451.8 to 3426.7)     Day 7 15193.4 (12335.9 to 18712.8) 22689.7 (18949.8 to 27167.7)
No statistical analyses for this end point

Secondary: SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster (Third) Dose Top of page

Secondary: SSC: Percentages of Subjects With Seroresponse to Reference Strain at 7 Days After the Booster (Third) Dose Top of page
End point title	SSC: Percentages of Subjects With Seroresponse to Reference Strain at 7 Days After the Booster (Third) Dose [175]
End point description	Seroresponse was defined as achieving >= 4-fold rise from before booster (third) dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse to reference strain at 7 days after the booster (third) dose was reported in this endpoint. This analysis is based on the first approximately 100 subjects. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	7 days after the booster (third) dose
Notes [175] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 52 47 Units: Percentage of subjects     number (confidence interval 95%) 71.2 (56.9 to 82.9) 68.1 (52.9 to 80.9)
No statistical analyses for this end point

Secondary: SSC: Percentages of Subjects With Seroresponse to Reference Strain at 7 Days After the Booster (Third) Dose Top of page

Secondary: SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline (Before the Third Dose) to 7 Days After the Booster (Third) Dose Top of page
End point title	SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline (Before the Third Dose) to 7 Days After the Booster (Third) Dose [176]
End point description	GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline (before the third dose) to 7 days after the booster (third) dose was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). This analysis is based on the first approximately 100 subjects. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	From baseline (before the third dose) to 7 days after the booster (third) dose
Notes [176] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 52 47 Units: Fold rise     geometric mean (confidence interval 95%) 8.2 (5.9 to 11.5) 10.2 (6.8 to 15.2)
No statistical analyses for this end point

Secondary: SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline (Before the Third Dose) to 7 Days After the Booster (Third) Dose Top of page

Secondary: SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline (Before the Third Dose) to 7 Days After the Booster (Third) Dose Top of page
End point title	SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline (Before the Third Dose) to 7 Days After the Booster (Third) Dose [177]
End point description	GMFR of SARS-CoV-2 Omicron BA.1-strain-neutralizing titers from baseline (before the third dose) to 7 days after the booster (third) dose was reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution). This analysis is based on the first approximately 100 subjects. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	From baseline (before the third dose) to 7 days after the booster (third) dose
Notes [177] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 49 47 Units: Fold rise     geometric mean (confidence interval 95%) 19.7 (12.3 to 31.6) 20.2 (11.7 to 35.0)
No statistical analyses for this end point

Secondary: SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline (Before the Third Dose) to 7 Days After the Booster (Third) Dose Top of page

Secondary: SSC: Percentages of Subjects With Seroresponse to Omicron BA.1 at 7 Days After the Booster (Third) Dose Top of page
End point title	SSC: Percentages of Subjects With Seroresponse to Omicron BA.1 at 7 Days After the Booster (Third) Dose [178]
End point description	Seroresponse was defined as achieving >= 4-fold rise from before booster (third) dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of >= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of subjects achieving seroresponse to Omicron BA.1 strain at 7 days after the booster (third) dose was reported in this endpoint. This analysis is based on the first approximately 100 subjects. All-available immunogenicity population included all randomised or assigned subjects who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	7 days after the booster (third) dose
Notes [178] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSC reporting groups only.
End point values SSC: BNT162b2 10 mcg SSC:BNT162b2 30 mcg Number of subjects analysed 49 47 Units: Percentage of subjects     number (confidence interval 95%) 77.6 (63.4 to 88.2) 74.5 (59.7 to 86.1)
No statistical analyses for this end point

Secondary: SSC: Percentages of Subjects With Seroresponse to Omicron BA.1 at 7 Days After the Booster (Third) Dose Top of page

Secondary: SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age Top of page
End point title	SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age [179]
End point description	GMT of SARS-CoV-2 Reference strain–neutralizing titers at 1 month after the study vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). 230 subjects were randomly selected from each group for immunogenicity analysis. Evaluable immunogenicity population included all eligible randomised subjects who received the study intervention to which they are randomised, have a valid and determinate immunogenicity within 28-42 days after thestudy vaccination, and have no other important protocol deviations as determined by the clinician. Subjects without evidence of prior infection were included in the analysis. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
End point type	Secondary
End point timeframe	1 month after study vaccination
Notes [179] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This analysis was planned to be analysed in SSE reporting groups only.
End point values SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg Number of subjects analysed 182 186 180 Units: Titer     geometric mean (confidence interval 95%) 5998.1 (5223.6 to 6887.4) 5933.2 (5188.2 to 6785.2) 7816.9 (6820.7 to 8958.6)
Statistical analysis title	BNT 30 mcg +BNT OMI 30 mcg vs BNT 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 [30 mcg] + BNT162b2 OMI [30 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on the student t distribution.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT 30 mcg +BNT OMI 30 mcg
Number of subjects included in analysis	362
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	1.3
Confidence interval
level	95%
sides	2-sided
lower limit	1.07
upper limit	1.58
Statistical analysis title	BNT 15 mcg + BNT OMI 15 mcg vs BNT 30 mcg
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 [15 mcg] + BNT162b2 OMI [15 mcg] - BNT162b2 [30 mcg]) and the corresponding CIs based on the student t distribution.
Comparison groups	SSE: Expanded Cohort (> 55 years): BNT162b2 30 mcg v SSE: Expanded Cohort (> 55 years): BNT 15 mcg + BNT OMI 15 mcg
Number of subjects included in analysis	368
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Geometric mean ratio (GMR)
Point estimate	0.99
Confidence interval
level	95%
sides	2-sided
lower limit	0.82
upper limit	1.2

Secondary: SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Adverse event reporting additional description	Same event may appear as both AE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both AE and non-SAE. For SSB, SSC and SSF, MedDRA version used is v25.1.
Assessment type	Non-systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	v25.0
Reporting groups
Reporting group title	SSA: BNT162b2 30 mcg- Blinded and Open Label Period
Reporting group description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSA: Original Placebo/BNT162b2 (30 mcg)- Open Label Period
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSB: BNT162b2
Reporting group description	Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSB: Placebo
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Reporting group title	SSF: BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSA: Placebo: Blinded Period
Reporting group description	Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
Reporting group title	SSF: BNT162b2 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 OMI 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 OMI 60 mcg
Reporting group description	Subjects received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Reporting group description	Subjects received a total of 30 mcg BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Reporting group description	Subjects received a total of 60 mcg BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSC: BNT162b2 10 mcg
Reporting group description	Subjects received one dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Reporting group title	SSC: BNT162b2 30 mcg
Reporting group description	Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
Serious adverse events SSA: BNT162b2 30 mcg- Blinded and Open Label Period SSA: Original Placebo/BNT162b2 (30 mcg)- Open Label Period SSB: BNT162b2 SSB: Placebo SSF: BNT162b2 30 mcg SSA: Placebo: Blinded Period SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg SSC: BNT162b2 10 mcg SSC: BNT162b2 30 mcg Total subjects affected by serious adverse events      subjects affected / exposed 73 / 5080 (1.44%) 45 / 4429 (1.02%) 2 / 1453 (0.14%) 2 / 1463 (0.14%) 0 / 21 (0.00%) 42 / 5041 (0.83%) 1 / 19 (5.26%) 1 / 21 (4.76%) 0 / 20 (0.00%) 1 / 20 (5.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 1 / 65 (1.54%)      number of deaths (all causes) 5 5 0 0 0 2 0 0 0 0 0 0 0      number of deaths resulting from adverse events 0 0 0 0 0 0 0 0 0 0 0 0 0 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenocortical carcinoma      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Adenocarcinoma of colon      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acute lymphocytic leukaemia      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Biliary neoplasm      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Breast cancer      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Breast cancer stage II      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Brain neoplasm      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Follicular lymphoma      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Invasive ductal breast carcinoma      subjects affected / exposed 2 / 5080 (0.04%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatic cancer metastatic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatic adenoma      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lung carcinoma cell type unspecified stage II      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Malignant melanoma in situ      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nervous system neoplasm      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ovarian cancer      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatic carcinoma metastatic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatic carcinoma      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pituitary tumour benign      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Prostate cancer      subjects affected / exposed 3 / 5080 (0.06%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal cell carcinoma      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Breast cancer stage I      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Uterine cancer      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Squamous cell carcinoma of the vagina      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Colorectal adenoma      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Rhabdomyosarcomas alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 1 / 1463 (0.07%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Vascular disorders Deep vein thrombosis      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypertension      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Shock haemorrhagic      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Penetrating aortic ulcer      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pregnancy, puerperium and perinatal conditions Abortion spontaneous      subjects affected / exposed 2 / 5080 (0.04%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 1 / 1463 (0.07%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 1 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Abortion complete      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Abortion incomplete      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 General disorders and administration site conditions Non-cardiac chest pain      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Death      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Chest pain      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sudden cardiac death      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Immune system disorders Food allergy      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Reproductive system and breast disorders Adenomyosis      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory, thoracic and mediastinal disorders Acute respiratory failure      subjects affected / exposed 1 / 5080 (0.02%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Chronic obstructive pulmonary disease      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 1 / 20 (5.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dyspnoea      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 1 / 19 (5.26%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory failure      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pleural effusion      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary embolism      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 3 / 5041 (0.06%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Psychiatric disorders Suicidal ideation      subjects affected / exposed 1 / 5080 (0.02%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Completed suicide      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Investigations Hepatic enzyme increased      subjects affected / exposed 2 / 5080 (0.04%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 2 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Injury, poisoning and procedural complications Acetabulum fracture      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Arterial injury      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Clavicle fracture      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Craniocerebral injury      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Femur fracture      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Joint dislocation      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Humerus fracture      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hip fracture      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Road traffic accident      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pelvic fracture      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ligament rupture      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Stoma complication      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Subdural haematoma      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Thoracic vertebral fracture      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ankle fracture      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Multiple injuries      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Concussion alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 1 / 1453 (0.07%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Congenital, familial and genetic disorders Hypertrophic cardiomyopathy      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac disorders Acute myocardial infarction      subjects affected / exposed 3 / 5080 (0.06%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac failure      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Atrial fibrillation      subjects affected / exposed 3 / 5080 (0.06%) 2 / 4429 (0.05%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Coronary artery disease      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Myocardial infarction      subjects affected / exposed 2 / 5080 (0.04%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 2 1 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Myopericarditis      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Coronary artery insufficiency      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pericarditis      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ventricular extrasystoles      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tachycardia      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nervous system disorders Cerebral haemorrhage      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cerebral venous thrombosis      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cerebrovascular accident      subjects affected / exposed 2 / 5080 (0.04%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intracranial aneurysm      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Seizure      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Toxic encephalopathy      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Syncope      subjects affected / exposed 3 / 5080 (0.06%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Toxic leukoencephalopathy      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Headache      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Migraine alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 1 / 1453 (0.07%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Blood and lymphatic system disorders Sickle cell anaemia with crisis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ear and labyrinth disorders Vertigo alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 1 / 21 (4.76%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal disorders Colitis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastric fistula      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hiatus hernia      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal haemorrhage      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lower gastrointestinal haemorrhage      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intestinal perforation      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatitis acute      subjects affected / exposed 1 / 5080 (0.02%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Small intestinal obstruction      subjects affected / exposed 1 / 5080 (0.02%) 2 / 4429 (0.05%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 2 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Upper gastrointestinal haemorrhage      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatic pseudocyst      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Constipation      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 1 / 65 (1.54%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatobiliary disorders Bile duct stone      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Skin and subcutaneous tissue disorders Vitiligo      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal and urinary disorders End stage renal disease      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acute kidney injury      subjects affected / exposed 0 / 5080 (0.00%) 2 / 4429 (0.05%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 2 / 5041 (0.04%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal cyst      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nephrolithiasis      subjects affected / exposed 3 / 5080 (0.06%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal infarct      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Endocrine disorders Goitre      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Back pain      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Arthralgia      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intervertebral disc protrusion      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intervertebral disc space narrowing      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Osteoarthritis      subjects affected / exposed 1 / 5080 (0.02%) 4 / 4429 (0.09%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 4 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Osteonecrosis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Spinal osteoarthritis      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Spondylolisthesis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Neck pain      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Spinal stenosis      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infections and infestations Abdominal sepsis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Appendicitis perforated      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acquired immunodeficiency syndrome      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Abdominal abscess      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 COVID-19 pneumonia      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 COVID-19      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Appendicitis      subjects affected / exposed 3 / 5080 (0.06%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Arthritis bacterial      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Complicated appendicitis      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cholangitis infective      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis alternative dictionary used: MedDRA v25.1      subjects affected / exposed 1 / 5080 (0.02%) 1 / 4429 (0.02%) 1 / 1453 (0.07%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 1 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Device related infection      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis      subjects affected / exposed 1 / 5080 (0.02%) 2 / 4429 (0.05%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infected skin ulcer      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Diverticulitis      subjects affected / exposed 1 / 5080 (0.02%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Liver abscess      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infection      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lyme disease      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Osteomyelitis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pelvic abscess      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Peritonitis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumocystis jirovecii pneumonia      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Septic shock      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sepsis      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Salmonellosis      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Staphylococcal skin infection      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract infection      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Empyema      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchitis      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metabolism and nutrition disorders Hypervolaemia      subjects affected / exposed 1 / 5080 (0.02%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Obesity      subjects affected / exposed 0 / 5080 (0.00%) 1 / 4429 (0.02%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 1%
Non-serious adverse events SSA: BNT162b2 30 mcg- Blinded and Open Label Period SSA: Original Placebo/BNT162b2 (30 mcg)- Open Label Period SSB: BNT162b2 SSB: Placebo SSF: BNT162b2 30 mcg SSA: Placebo: Blinded Period SSF: BNT162b2 60 mcg SSF: BNT162b2 OMI 30 mcg SSF: BNT162b2 OMI 60 mcg SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg SSC: BNT162b2 10 mcg SSC: BNT162b2 30 mcg Total subjects affected by non serious adverse events      subjects affected / exposed 1201 / 5080 (23.64%) 771 / 4429 (17.41%) 1180 / 1453 (81.21%) 615 / 1463 (42.04%) 17 / 21 (80.95%) 202 / 5041 (4.01%) 19 / 19 (100.00%) 20 / 21 (95.24%) 18 / 20 (90.00%) 18 / 20 (90.00%) 20 / 21 (95.24%) 49 / 75 (65.33%) 57 / 65 (87.69%) Investigations SARS-CoV-2 test positive alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 18 / 1453 (1.24%) 26 / 1463 (1.78%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 0 0 18 26 0 0 0 0 0 0 0 0 0 Nervous system disorders Headache      subjects affected / exposed 267 / 5080 (5.26%) 144 / 4429 (3.25%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 54 / 5041 (1.07%) 0 / 19 (0.00%) 1 / 21 (4.76%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 269 144 0 0 0 54 0 1 0 0 0 0 0 Headache (HEADACHE) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 585 / 1453 (40.26%) 332 / 1463 (22.69%) 6 / 21 (28.57%) 0 / 5041 (0.00%) 5 / 19 (26.32%) 5 / 21 (23.81%) 11 / 20 (55.00%) 7 / 20 (35.00%) 8 / 21 (38.10%) 31 / 75 (41.33%) 34 / 65 (52.31%)      occurrences all number 0 0 585 332 6 0 5 5 11 7 8 31 34 Syncope alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 1 / 19 (5.26%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 0 0 0 0 1 0 0 0 0 0 1 Blood and lymphatic system disorders Lymphadenopathy      subjects affected / exposed 141 / 5080 (2.78%) 59 / 4429 (1.33%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 3 / 5041 (0.06%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 147 59 0 0 0 3 0 0 0 0 0 0 0 General disorders and administration site conditions Chills      subjects affected / exposed 243 / 5080 (4.78%) 107 / 4429 (2.42%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 11 / 5041 (0.22%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 243 107 0 0 0 11 0 0 0 0 0 0 0 Pyrexia      subjects affected / exposed 258 / 5080 (5.08%) 142 / 4429 (3.21%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 8 / 5041 (0.16%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 258 143 0 0 0 8 0 0 0 0 0 0 0 Pain      subjects affected / exposed 139 / 5080 (2.74%) 122 / 4429 (2.75%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 16 / 5041 (0.32%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 140 122 0 0 0 16 0 0 0 0 0 0 0 Injection site pain      subjects affected / exposed 673 / 5080 (13.25%) 412 / 4429 (9.30%) 17 / 1453 (1.17%) 3 / 1463 (0.21%) 0 / 21 (0.00%) 83 / 5041 (1.65%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 675 412 17 3 0 83 0 0 0 0 0 0 0 Fatigue      subjects affected / exposed 383 / 5080 (7.54%) 228 / 4429 (5.15%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 66 / 5041 (1.31%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 383 228 0 0 0 66 0 0 0 0 0 0 0 Chills (CHILLS) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 278 / 1453 (19.13%) 69 / 1463 (4.72%) 3 / 21 (14.29%) 0 / 5041 (0.00%) 3 / 19 (15.79%) 5 / 21 (23.81%) 5 / 20 (25.00%) 1 / 20 (5.00%) 3 / 21 (14.29%) 10 / 75 (13.33%) 15 / 65 (23.08%)      occurrences all number 0 0 278 69 3 0 3 5 5 1 3 10 15 Injection site swelling (SWELLING) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 86 / 1453 (5.92%) 7 / 1463 (0.48%) 3 / 21 (14.29%) 0 / 5041 (0.00%) 3 / 19 (15.79%) 3 / 21 (14.29%) 3 / 20 (15.00%) 3 / 20 (15.00%) 6 / 21 (28.57%) 2 / 75 (2.67%) 6 / 65 (9.23%)      occurrences all number 0 0 86 7 3 0 3 3 3 3 6 2 6 Fatigue (FATIGUE) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 723 / 1453 (49.76%) 356 / 1463 (24.33%) 10 / 21 (47.62%) 0 / 5041 (0.00%) 7 / 19 (36.84%) 9 / 21 (42.86%) 11 / 20 (55.00%) 10 / 20 (50.00%) 12 / 21 (57.14%) 37 / 75 (49.33%) 35 / 65 (53.85%)      occurrences all number 0 0 723 356 10 0 7 9 11 10 12 37 35 Injection site erythema (REDNESS) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 74 / 1453 (5.09%) 9 / 1463 (0.62%) 4 / 21 (19.05%) 0 / 5041 (0.00%) 4 / 19 (21.05%) 5 / 21 (23.81%) 4 / 20 (20.00%) 2 / 20 (10.00%) 6 / 21 (28.57%) 1 / 75 (1.33%) 4 / 65 (6.15%)      occurrences all number 0 0 74 9 4 0 4 5 4 2 6 1 4 Injection site pain (PAIN) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 1038 / 1453 (71.44%) 163 / 1463 (11.14%) 15 / 21 (71.43%) 0 / 5041 (0.00%) 18 / 19 (94.74%) 19 / 21 (90.48%) 16 / 20 (80.00%) 15 / 20 (75.00%) 19 / 21 (90.48%) 42 / 75 (56.00%) 50 / 65 (76.92%)      occurrences all number 0 0 1038 163 15 0 18 19 16 15 19 42 50 Pyrexia (FEVER) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 74 / 1453 (5.09%) 17 / 1463 (1.16%) 2 / 21 (9.52%) 0 / 5041 (0.00%) 2 / 19 (10.53%) 2 / 21 (9.52%) 2 / 20 (10.00%) 1 / 20 (5.00%) 1 / 21 (4.76%) 3 / 75 (4.00%) 4 / 65 (6.15%)      occurrences all number 0 0 74 17 2 0 2 2 2 1 1 3 4 Immune system disorders Seasonal allergy      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 Eye disorders Eye pruritis alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 1 / 20 (5.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 Gastrointestinal disorders Nausea      subjects affected / exposed 54 / 5080 (1.06%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 16 / 5041 (0.32%) 0 / 19 (0.00%) 0 / 21 (0.00%) 1 / 20 (5.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 54 0 0 0 0 16 0 0 1 0 0 0 0 Diarrhoea (DIARRHEA) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 109 / 1453 (7.50%) 77 / 1463 (5.26%) 3 / 21 (14.29%) 0 / 5041 (0.00%) 1 / 19 (5.26%) 2 / 21 (9.52%) 1 / 20 (5.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 3 / 75 (4.00%) 6 / 65 (9.23%)      occurrences all number 0 0 109 77 3 0 1 2 1 0 0 3 6 Vomiting (VOMITING) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 37 / 1453 (2.55%) 13 / 1463 (0.89%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 1 / 75 (1.33%) 2 / 65 (3.08%)      occurrences all number 0 0 37 13 0 0 0 0 0 0 0 1 2 Abdominal pain alternative dictionary used: MedDRA v25.1      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 1 / 20 (5.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 Reproductive system and breast disorders Dysmenorrhoea      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 Respiratory, thoracic and mediastinal disorders Rhinitis allergic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 Epistaxis      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 1 / 75 (1.33%) 0 / 65 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 Psychiatric disorders Attention deficit-hyperactivity disorder      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 2 / 65 (3.08%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 2 Musculoskeletal and connective tissue disorders Myalgia      subjects affected / exposed 248 / 5080 (4.88%) 118 / 4429 (2.66%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 21 / 5041 (0.42%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 248 119 0 0 0 21 0 0 0 0 0 0 0 Pain in extremity      subjects affected / exposed 58 / 5080 (1.14%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 1 / 5041 (0.02%) 0 / 19 (0.00%) 1 / 21 (4.76%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 58 0 0 0 0 1 0 1 0 0 0 0 0 Arthralgia (JOINT PAIN) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 178 / 1453 (12.25%) 55 / 1463 (3.76%) 3 / 21 (14.29%) 0 / 5041 (0.00%) 3 / 19 (15.79%) 3 / 21 (14.29%) 4 / 20 (20.00%) 2 / 20 (10.00%) 2 / 21 (9.52%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 0 0 178 55 3 0 3 3 4 2 2 0 0 Myalgia (MUSCLE PAIN) alternative dictionary used: MedDRA v25.1 alternative assessment type: Systematic      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 402 / 1453 (27.67%) 88 / 1463 (6.02%) 4 / 21 (19.05%) 0 / 5041 (0.00%) 8 / 19 (42.11%) 5 / 21 (23.81%) 6 / 20 (30.00%) 5 / 20 (25.00%) 6 / 21 (28.57%) 0 / 75 (0.00%) 0 / 65 (0.00%)      occurrences all number 0 0 402 88 4 0 8 5 6 5 6 0 0 Arthralgia      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 1 / 75 (1.33%) 0 / 65 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 Infections and infestations Ear infections      subjects affected / exposed 0 / 5080 (0.00%) 0 / 4429 (0.00%) 0 / 1453 (0.00%) 0 / 1463 (0.00%) 0 / 21 (0.00%) 0 / 5041 (0.00%) 0 / 19 (0.00%) 0 / 21 (0.00%) 0 / 20 (0.00%) 0 / 20 (0.00%) 0 / 21 (0.00%) 1 / 75 (1.33%) 0 / 65 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
28 Oct 2021	Addition of Substudy B
28 Oct 2021	Addition of Substudy C.
22 Dec 2021	Addition of Sub study D.
20 Jan 2022	Addition of Substudy F. Confirmation of the safety reporting time periods for Substudy F.
20 Jan 2022	Updated timing for unblinding of the subjects to 3 months after study vaccination administration.
20 Jan 2022	Updated timing of subject unblinding for Cohort 2 from Visit 402 to Visit 404 and added that Cohort 1 (Groups 1 and 2b) may also be unblinded at this time.
08 Feb 2022	Updated text to clarify that subjects may be enrolled if they completed a 2-dose primary series of BNT162b2 (30 mcg doses) at least 5 months prior to randomisation for all subjects.
08 Feb 2022	Updated text to clarify that subjects may be enrolled if they completed a 2-dose primary series of BNT162b2 (30-mcg doses) at least 5 months prior to randomisation instead of 6 months prior for all subjects.
08 Feb 2022	Updated text to clarify that Cohort 1 subjects must have received 2 doses of BNT162b2 before enrollment (3-8 months after last dose). Updated text to clarify that subjects will receive 2 doses (primary series) of BNT162b2 OMI, separated by 21 days, with a third dose approximately 5 months later. Updated text to clarify that Vaccination 3 may be administered as early as 5 months (150 days) after Vaccination 2.
21 Mar 2022	Added text for Cohort 2 to clarify that subjects will be offered a dose of BNT162b2 OMI at Visit 404 (3-month follow-up). Removed text stating that Group 4 may not be enrolled. Added text to clarify the AE collection time period for Group 3 and Group 4 subjects who will receive a dose of BNT162b2 OMI at Visit 404.
03 May 2022	Added text to allow inclusion of subjects who have received a booster (third) dose of BNT162b2 at least 4 months prior to randomisation. Timing of prior BNT162b2 for subjects with 2 prior doses updated to 4 months prior to randomisation.
20 Jun 2022	Addition of sub study E; Confirmation of the safety reporting time periods for sub study E.
20 Sep 2022	Confirmation that progression beyond the 12 - 17 years age group in Substudy C will not occur and no further subjects will be enrolled. Confirmed up to 150 subjects will be enrolled. Removed the 12-month follow-up visit and the 20-mL blood sample for subjects >= 18 years of age, the final visit will be 6 months after the last dose.
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
4 subjects in SSE received different dosing than that specified by the protocol due to medication errors. Hence, they were not included in the safety analysis.

More information Top of page