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Clinical Trial Results:
A Phase 2/3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA - Based Vaccine Candidates for SARS-Cov-2 New Variants in Healthy Individuals

Summary
EudraCT number	2024-000361-24
Trial protocol	Outside EU/EEA
Global end of trial date	11 Mar 2025

Results information
Results version number	v2(current)
This version publication date	23 Oct 2025
First version publication date	20 Dec 2024
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

C4591054

ISRCTN number

US NCT number

NCT05997290

WHO universal trial number (UTN)

Sponsor organisation name

BioNTech SE

Sponsor organisation address

An der Goldgrube 12, Mainz, Germany, 55131

Public contact

BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de

Scientific contact

BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

04 May 2025

Is this the analysis of the primary completion data?

Yes

Primary completion date

11 Mar 2025

Global end of trial reached?

Yes

Global end of trial date

11 Mar 2025

Was the trial ended prematurely?

Main objective of the trial

To evaluate the safety and tolerability and immunogenicity of one or more SARS-CoV-2 variant-adapted BNT162b2 vaccine candidates in the following substudies:SSA - BNT162b2 (Omi XBB.1.5) in COVID-19 vaccine–experienced participants ≥12 years of age.SSB - BNT162b2 (Omi XBB.1.5) as a single dose in participants ≥12 years of age who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine naïve.SSC - BNT162b2 (Omi JN.1) as a single dose in participants ≥18 years of age (Cohort 1) and ≥12 years of age (Cohort 2) and BNT162b2 (Omi KP.2) as a single dose in participants ≥18 years of age (Cohort 3).

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 participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Aug 2023

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 1041

Worldwide total number of subjects

1041

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

723

From 65 to 84 years

259

85 years and over

Subject disposition

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Recruitment details

In this study there were 3 sub-studies: sub-study A (SSA), sub-study B (SSB), and sub-study C (SSC).

Screening details

SSA: A total of 417 participants were screened, out of which, 412 were vaccinated. SSB: A total of 311 participants were screened and vaccinated. SSC: A total of 321 participants were screened, out of which 318 were vaccinated.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Blinding implementation details

Not applicable

Are arms mutually exclusive

Yes

SSA: Group 1: 12-17 years

Arm description

Participants aged 12 to 17 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via intramuscular (IM) route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi XBB.1.5)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

SSA: Group 2: 18-55 years

Arm description

Participants aged 18 to 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi XBB.1.5)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

SSA: Group 3: >55 years

Arm description

Participants aged greater than (>) 55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi XBB.1.5)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

SSB: Group 1: 12-17 years

Arm description

Participants aged 12-17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi XBB.1.5)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

SSB: Group 2: 18-55 years

Arm description

Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi XBB.1.5)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

SSB: Group 3: >55 years

Arm description

Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi XBB.1.5)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (Omi XBB.1.5) administered intramuscularly.

SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years

Arm description

Participants aged 12-17 years received a single dose of BNT162b2 (Omi JN.1)30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi JN.1)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (OmiJN.1) administered intramuscularly.

SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years

Arm description

Participants aged 18-55 years received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi JN.1)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (OmiJN.1) administered intramuscularly.

SSC: Cohort 1 and Cohort 2 Combined: > 55 Years

Arm description

Participants aged >55 years received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi JN.1)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (OmiJN.1) administered intramuscularly.

SSC: Cohort 3: 18-55 Years

Arm description

Participants aged 18-55 years received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi KP.2)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (OmiKP.2) administered intramuscularly.

SSC: Cohort 3: > 55 Years

Arm description

Participants aged >55 years received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 (Omi KP.2)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received a single dose of 30 mcg BNT162b2 (OmiKP.2) administered intramuscularly.

Number of subjects in period 1	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSB: Group 3: >55 years	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years
Started	30	174	208	9	253	49	18	92	106	51	51
Safety Population	30	174	208	9	253	49	18	92	106	51	51
Evaluable Immunogenicity Population	27 ^[1]	167 ^[2]	188 ^[3]	9	243	47	18	91	103	50	50
Completed	29	172	203	9	225	44	18	87	100	48	49
Not completed	1	2	5	0	28	5	0	5	6	3	2
Adverse event, serious fatal	-	-	1	-	-	-	-	-	1	-	-
Consent withdrawn by subject	1	-	2	-	6	1	-	2	1	1	-
Unspecified	-	-	-	-	-	-	-	-	-	1	-
Lost to follow-up	-	2	-	-	22	4	-	3	2	-	1
Protocol deviation	-	-	2	-	-	-	-	-	2	1	1

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

Baseline characteristics

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Reporting group title

SSA: Group 1: 12-17 years

Reporting group description

Reporting group title

SSA: Group 2: 18-55 years

Reporting group description

Reporting group title

SSA: Group 3: >55 years

Reporting group description

Reporting group title

SSB: Group 1: 12-17 years

Reporting group description

Reporting group title

SSB: Group 2: 18-55 years

Reporting group description

Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSB: Group 3: >55 years

Reporting group description

Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years

Reporting group description

Participants aged 12-17 years received a single dose of BNT162b2 (Omi JN.1)30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years

Reporting group description

Participants aged 18-55 years received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: > 55 Years

Reporting group description

Participants aged >55 years received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 3: 18-55 Years

Reporting group description

Participants aged 18-55 years received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 3: > 55 Years

Reporting group description

Participants aged >55 years received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Reporting group values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSB: Group 3: >55 years	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	Total
Number of subjects	30	174	208	9	253	49	18	92	106	51	51	1041
Age categorical
Units: Participants
Adolescents (12-17 years)	30	0	0	9	0	0	18	0	0	0	0	57
Adults (18-64 years)	0	174	63	0	253	27	0	92	45	51	18	723
From 65-84 years	0	0	143	0	0	22	0	0	61	0	33	259
85 years and over	0	0	2	0	0	0	0	0	0	0	0	2
Age Continuous
Units: years
arithmetic mean (standard deviation)	14.0 ( 1.74 )	40.4 ( 9.82 )	68.6 ( 6.74 )	14.6 ( 1.67 )	34.5 ( 10.43 )	64.0 ( 6.35 )	15.1 ( 1.49 )	38.3 ( 10.93 )	66.3 ( 6.57 )	41.2 ( 8.55 )	67.1 ( 6.59 )	-
Gender Categorical
Units: Participants
Female	19	100	123	5	138	23	8	60	58	35	27	596
Male	11	74	85	4	115	26	10	32	48	16	24	445
Race
Units: Subjects
White	26	135	164	2	162	30	15	60	76	39	37	746
Black or African American	3	23	27	7	87	16	2	20	16	6	7	214
American Indian or Alaska Native	0	0	1	0	0	1	0	1	1	0	0	4
Asian	1	11	10	0	4	2	0	6	6	4	6	50
Native Hawaiian or other Pacific Islander	0	0	2	0	0	0	0	0	1	0	0	3
Multiracial	0	5	3	0	0	0	1	4	6	2	1	22
Unknown	0	0	1	0	0	0	0	1	0	0	0	2
Ethnicity
Units: Subjects
Hispanic/Latino	6	35	34	3	136	19	1	20	29	6	9	298
Non-Hispanic/non-Latino	24	138	173	6	117	30	17	72	76	44	42	739
Not reported	0	1	1	0	0	0	0	0	1	1	0	4

Subject analysis set title

SSA Total Study Participants: C4591054

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study. This analysis set is created for safety analysis.

Subject analysis set title

SSA Historical Control: 12-17 years

Subject analysis set type

Per protocol

Subject analysis set description

Participants from sub-study A of the current study C4591054 (NCT05997290) who aged 12 to 17 years who received BNT162b2 (Omi XBB.1.5) 30 mcg as historical control for immunogenicity analysis. This analysis set is created for analysis of this outcome measure.

Subject analysis set title

SSA Historical Control: 18-55 years

Subject analysis set type

Per protocol

Subject analysis set description

Participants from sub-study A of the current study C4591054 (NCT05997290) who aged 18 to 55 years who received BNT162b2 (Omi XBB.1.5) 30 mcg as historical control for immunogenicity analysis. This analysis set is created for analysis of this outcome measure.

Subject analysis set title

SSA Historical Control: >55 years

Subject analysis set type

Per protocol

Subject analysis set description

Participants from sub-study A of the current study C4591054 (NCT05997290) who aged > 55 years who received BNT162b2 (Omi XBB.1.5) 30 mcg as historical control for immunogenicity analysis. This analysis set is created for analysis of this outcome measure.

Subject analysis set title

SSA Historical Control: All Age Groups

Subject analysis set type

Per protocol

Subject analysis set description

Participants from sub-study A of the current study C4591054 (NCT05997290) of any age group who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study. This analysis set is created for analysis of this outcome measure.

Subject analysis set title

SSA Total Historical Control: C4591044 BNT162b2

Subject analysis set type

Per protocol

Subject analysis set description

Participants from study C4591044 (NCT05472038) Cohort 2/Cohort 3 who received bivalent BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as a fourth dose were used as historical control for immunogenicity. This analysis set is created for immunogenicity analysis.

Subject analysis set title

SSB Total Study Participants

Subject analysis set type

Safety analysis

Subject analysis set description

Participants aged >=12 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSB. This analysis set is created for safety analysis.

Subject analysis set title

SSB: Vaccine-Naïve Substudy B

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSB Control: Vaccine-Experienced Substudy A

Subject analysis set type

Per protocol

Subject analysis set description

Participants who received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSA were included. This analysis set is created for immunogenicity analysis.

Subject analysis set title

SSC: Cohort 1 and Cohort 2 Combined: All Age Groups

Subject analysis set type

Per protocol

Subject analysis set description

Participants of any age group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study. This analysis set is created for analysis of this outcome measure.

Subject analysis set title

SSC: Cohort 3 Combined: All Age Groups

Subject analysis set type

Full analysis

Subject analysis set description

Participants of any age group who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study. This analysis set is created for safety analysis.

Subject analysis set title

SSC Cohort 1 and Cohort 2 Combined BNT162b2

Subject analysis set type

Full analysis

Subject analysis set description

Participants received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study. This analysis set is created for evaluable immunogenicity population.

Subject analysis sets values	SSA Total Study Participants: C4591054	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2	SSB Total Study Participants	SSB: Vaccine-Naïve Substudy B	SSB Control: Vaccine-Experienced Substudy A	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups	SSC: Cohort 3 Combined: All Age Groups	SSC Cohort 1 and Cohort 2 Combined BNT162b2
Number of subjects	412	15	85	100	382	200	311	299	296	1	1	1
Age categorical
Units: Participants
Adolescents (12-17 years)											0	0
Adults (18-64 years)											0	0
From 65-84 years											0	0
85 years and over											0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	0 ( )	0 ( )
Gender Categorical
Units: Participants
Female											0	0
Male											0	0
Race
Units: Subjects
White											0	0
Black or African American											0	0
American Indian or Alaska Native											0	0
Asian											0	0
Native Hawaiian or other Pacific Islander											0	0
Multiracial											0	0
Unknown											0	0
Ethnicity
Units: Subjects
Hispanic/Latino											0	0
Non-Hispanic/non-Latino											0	0
Not reported											0	0

End points

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Reporting group title

SSA: Group 1: 12-17 years

Reporting group description

Reporting group title

SSA: Group 2: 18-55 years

Reporting group description

Reporting group title

SSA: Group 3: >55 years

Reporting group description

Reporting group title

SSB: Group 1: 12-17 years

Reporting group description

Reporting group title

SSB: Group 2: 18-55 years

Reporting group description

Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSB: Group 3: >55 years

Reporting group description

Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years

Reporting group description

Participants aged 12-17 years received a single dose of BNT162b2 (Omi JN.1)30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years

Reporting group description

Participants aged 18-55 years received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: > 55 Years

Reporting group description

Participants aged >55 years received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 3: 18-55 Years

Reporting group description

Participants aged 18-55 years received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 3: > 55 Years

Reporting group description

Participants aged >55 years received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Subject analysis set title

SSA Total Study Participants: C4591054

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

SSA Historical Control: 12-17 years

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSA Historical Control: 18-55 years

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSA Historical Control: >55 years

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSA Historical Control: All Age Groups

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSA Total Historical Control: C4591044 BNT162b2

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSB Total Study Participants

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

SSB: Vaccine-Naïve Substudy B

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

SSB Control: Vaccine-Experienced Substudy A

Subject analysis set type

Per protocol

Subject analysis set description

Participants who received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSA were included. This analysis set is created for immunogenicity analysis.

Subject analysis set title

SSC: Cohort 1 and Cohort 2 Combined: All Age Groups

Subject analysis set type

Per protocol

Subject analysis set description

Participants of any age group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study. This analysis set is created for analysis of this outcome measure.

Subject analysis set title

SSC: Cohort 3 Combined: All Age Groups

Subject analysis set type

Full analysis

Subject analysis set description

Participants of any age group who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study. This analysis set is created for safety analysis.

Subject analysis set title

SSC Cohort 1 and Cohort 2 Combined BNT162b2

Subject analysis set type

Full analysis

Subject analysis set description

Participants received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study. This analysis set is created for evaluable immunogenicity population.

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

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End point title

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA ^[1] ^[2]

End point description

Local reactions: pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness & swelling measured & recorded in measuring device units (mdu)(range:1 to 21),1mdu=0.5 cm &were graded as mild (greater than[>] 2.0 to 5.0 cm),moderate(>5.0 to 10.0 cm),severe(>10.0 cm)&Grade 4(necrosis [swelling]&necrosis or exfoliative dermatitis[redness]).Pain at injection site graded as mild(did not interfere with activity),moderate(interfered with activity),severe(prevented daily activity)&Grade(G)4(emergency room [ER]visit or hospitalisation for severe pain at injection site).G4 LR classified by investigator or medically qualified person.Exact 2-sided confidence interval(CI)based on Clopper and Pearson method. Safety population: all participants who received study intervention.Number of Participants Analysed=Participants evaluable.

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

Notes
[1] - 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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Total Study Participants: C4591054
Number of subjects analysed	30	174	206	410
Units: Percentage of Participants
number (confidence interval 95%)
Redness: Any	10.0 (2.1 to 26.5)	4.0 (1.6 to 8.1)	5.8 (3.0 to 10.0)	5.4 (3.4 to 8.0)
Redness: Mild	6.7 (0.8 to 22.1)	3.4 (1.3 to 7.4)	3.9 (1.7 to 7.5)	3.9 (2.2 to 6.3)
Redness: Moderate	3.3 (0.1 to 17.2)	0.6 (0.0 to 3.2)	1.9 (0.5 to 4.9)	1.5 (0.5 to 3.2)
Redness: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Redness: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Swelling: Any	16.7 (5.6 to 34.7)	7.5 (4.0 to 12.4)	5.8 (3.0 to 10.0)	7.3 (5.0 to 10.3)
Swelling: Mild	13.3 (3.8 to 30.7)	5.7 (2.8 to 10.3)	3.9 (1.7 to 7.5)	5.4 (3.4 to 8.0)
Swelling: Moderate	3.3 (0.1 to 17.2)	1.7 (0.4 to 5.0)	1.9 (0.5 to 4.9)	2.0 (0.8 to 3.8)
Swelling: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Swelling: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Pain at the injection site: Any	80.0 (61.4 to 92.3)	75.9 (68.8 to 82.0)	52.4 (45.4 to 59.4)	64.4 (59.5 to 69.0)
Pain at the injection site: Mild	50.0 (31.3 to 68.7)	59.8 (52.1 to 67.1)	46.6 (39.6 to 53.7)	52.4 (47.5 to 57.4)
Pain at the injection site: Moderate	30.0 (14.7 to 49.4)	16.1 (11.0 to 22.4)	5.8 (3.0 to 10.0)	12.0 (9.0 to 15.5)
Pain at the injection site: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Pain at the injection site: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)

No statistical analyses for this end point

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

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End point title

Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA ^[3] ^[4]

End point description

Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 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 joint pain: mild (didn’t interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhoea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: All participants who received the study intervention. Number of Participants Analysed= Participants evaluable.

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Total Study Participants: C4591054
Number of subjects analysed	30	174	206	410
Units: Percentage of participants
number (confidence interval 95%)
Fever: Any	16.7 (5.6 to 34.7)	4.0 (1.6 to 8.1)	3.9 (1.7 to 7.5)	4.9 (3.0 to 7.4)
Fever: >=38.0 degree C to 38.4 degree C	10.0 (2.1 to 26.5)	3.4 (1.3 to 7.4)	2.4 (0.8 to 5.6)	3.4 (1.9 to 5.7)
Fever: >38.4 degree C to 38.9 degree C	3.3 (0.1 to 17.2)	0.6 (0.0 to 3.2)	1.0 (0.1 to 3.5)	1.0 (0.3 to 2.5)
Fever: >38.9 degree C to 40.0 degree C	3.3 (0.1 to 17.2)	0 (0.0 to 2.1)	0.5 (0.0 to 2.7)	0.5 (0.1 to 1.8)
Fever: >40.0 degree C	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Fatigue: Any	56.7 (37.4 to 74.5)	56.9 (49.2 to 64.4)	35.4 (28.9 to 42.4)	46.1 (41.2 to 51.1)
Fatigue: Mild	30.0 (14.7 to 49.4)	31.6 (24.8 to 39.1)	18.4 (13.4 to 24.4)	24.9 (20.8 to 29.4)
Fatigue: Moderate	26.7 (12.3 to 45.9)	24.1 (18.0 to 31.2)	17.0 (12.1 to 22.8)	20.7 (16.9 to 25.0)
Fatigue: Severe	0 (0.0 to 11.6)	1.1 (0.1 to 4.1)	0 (0.0 to 1.8)	0.5 (0.1 to 1.8)
Fatigue: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Headache: Any	36.7 (19.9 to 56.1)	43.7 (36.2 to 51.4)	26.2 (20.3 to 32.8)	34.4 (29.8 to 39.2)
Headache: Mild	30.0 (14.7 to 49.4)	31.0 (24.3 to 38.5)	20.4 (15.1 to 26.5)	25.6 (21.5 to 30.1)
Headache: Moderate	6.7 (0.8 to 22.1)	12.6 (8.1 to 18.5)	5.8 (3.0 to 10.0)	8.8 (6.2 to 11.9)
Headache: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Headache: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Chills: Any	20.0 (7.7 to 38.6)	9.2 (5.3 to 14.5)	9.2 (5.6 to 14.0)	10.0 (7.3 to 13.3)
Chills: Mild	10.0 (2.1 to 26.5)	6.9 (3.6 to 11.7)	6.3 (3.4 to 10.5)	6.8 (4.6 to 9.7)
Chills: Moderate	10.0 (2.1 to 26.5)	2.3 (0.6 to 5.8)	2.9 (1.1 to 6.2)	3.2 (1.7 to 5.4)
Chills: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Chills: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Vomiting: Any	0 (0.0 to 11.6)	2.3 (0.6 to 5.8)	0 (0.0 to 1.8)	1.0 (0.3 to 2.5)
Vomiting: Mild	0 (0.0 to 11.6)	2.3 (0.6 to 5.8)	0 (0.0 to 1.8)	1.0 (0.3 to 2.5)
Vomiting: Moderate	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Vomiting: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Vomiting: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Diarrhoea: Any	0 (0.0 to 11.6)	13.2 (8.6 to 19.2)	8.7 (5.3 to 13.5)	10.0 (7.3 to 13.3)
Diarrhoea: Mild	0 (0.0 to 11.6)	11.5 (7.2 to 17.2)	7.3 (4.1 to 11.7)	8.5 (6.0 to 11.7)
Diarrhoea: Moderate	0 (0.0 to 11.6)	1.1 (0.1 to 4.1)	1.5 (0.3 to 4.2)	1.2 (0.4 to 2.8)
Diarrhoea: Severe	0 (0.0 to 11.6)	0.6 (0.0 to 3.2)	0 (0.0 to 1.8)	0.2 (0.0 to 1.4)
Diarrhoea: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
New or worsened muscle pain: Any	23.3 (9.9 to 42.3)	21.8 (15.9 to 28.7)	12.1 (8.0 to 17.4)	17.1 (13.6 to 21.1)
New or worsened muscle pain: Mild	3.3 (0.1 to 17.2)	12.1 (7.6 to 17.9)	5.3 (2.7 to 9.4)	8.0 (5.6 to 11.1)
New or worsened muscle pain: Moderate	20.0 (7.7 to 38.6)	9.8 (5.8 to 15.2)	6.8 (3.8 to 11.1)	9.0 (6.4 to 12.2)
New or worsened muscle pain: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
New or worsened muscle pain: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
New or worsened joint pain: Any	16.7 (5.6 to 34.7)	14.4 (9.5 to 20.5)	7.8 (4.5 to 12.3)	11.2 (8.3 to 14.7)
New or worsened joint pain: Mild	6.7 (0.8 to 22.1)	8.6 (4.9 to 13.8)	5.3 (2.7 to 9.4)	6.8 (4.6 to 9.7)
New or worsened joint pain: Moderate	10.0 (2.1 to 26.5)	5.7 (2.8 to 10.3)	2.4 (0.8 to 5.6)	4.4 (2.6 to 6.8)
New or worsened joint pain: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
New or worsened joint pain: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)

No statistical analyses for this end point

Primary: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA

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End point title

Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA ^[5] ^[6]

End point description

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from study vaccination on Day 1 up to 1 month after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on 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 participants who received the study intervention.

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 1 month after vaccination

Notes
[5] - 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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Total Study Participants: C4591054
Number of subjects analysed	30	174	208	412
Units: Percentage of participants
number (confidence interval 95%)	16.7 (5.6 to 34.7)	7.5 (4.0 to 12.4)	8.2 (4.8 to 12.8)	8.5 (6.0 to 11.6)

No statistical analyses for this end point

Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Through 6 Months After the Study Vaccination: SSA

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End point title

Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Through 6 Months After the Study Vaccination: SSA ^[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; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; or considered as an important medical event. Percentage of participants reporting SAEs from study vaccination on Day 1 up to 6 months after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on Clopper and Pearson method. Safety population included all participants who received the study intervention.

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 6 months after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Total Study Participants: C4591054
Number of subjects analysed	30	174	208	412
Units: Percentage of Participants
number (confidence interval 95%)	3.3 (0.1 to 17.2)	0 (0.0 to 2.1)	1.9 (0.5 to 4.9)	1.2 (0.4 to 2.8)

No statistical analyses for this end point

Primary: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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End point title

Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 ^[9] ^[10]

End point description

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2
Number of subjects analysed	27	166	185	15	85	100	378	200
Units: Titer
geometric mean (confidence interval 95%)	3632.1 (2043.8 to 6454.7)	2503.6 (2003.0 to 3129.3)	2606.8 (2065.5 to 3289.9)	837.1 (459.5 to 1524.9)	615.5 (459.0 to 825.2)	560.4 (430.0 to 730.2)	2622.3 (2246.6 to 3060.9)	601.0 (499.5 to 723.1)

No statistical analyses for this end point

Primary: GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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End point title

GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 ^[11] ^[12]

End point description

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2
Number of subjects analysed	26	167	187	15	85	100	380	200
Units: Titer
geometric mean (confidence interval 95%)	7903.6 (4961.5 to 12590.4)	4831.8 (4044.5 to 5772.3)	5046.1 (4123.3 to 6175.3)	6376.3 (3568.4 to 11393.8)	3868.2 (2974.8 to 5029.9)	4122.7 (3261.2 to 5211.6)	5105.1 (4483.4 to 5813.0)	4146.0 (3512.6 to 4893.5)

No statistical analyses for this end point

Primary: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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End point title

Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 ^[13] ^[14]

End point description

GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.

End point type

Primary

End point timeframe

From before vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2
Number of subjects analysed	27	165	184	15	82	100	376	197
Units: Fold rise
geometric mean (confidence interval 95%)	11.8 (6.3 to 22.2)	10.7 (8.7 to 13.1)	13.5 (10.7 to 17.1)	7.1 (3.9 to 12.8)	6.1 (4.5 to 8.3)	5.2 (4.1 to 6.5)	12.1 (10.4 to 14.0)	5.7 (4.8 to 6.8)

No statistical analyses for this end point

Primary: GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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End point title

GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 ^[15] ^[16]

End point description

End point type

Primary

End point timeframe

From before vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2
Number of subjects analysed	26	167	186	15	85	100	379	200
Units: Fold rise
geometric mean (confidence interval 95%)	3.5 (2.2 to 5.8)	4.3 (3.7 to 5.0)	5.1 (4.3 to 6.2)	5.7 (3.4 to 9.4)	6.2 (4.6 to 8.4)	7.4 (5.7 to 9.6)	4.6 (4.1 to 5.2)	6.8 (5.6 to 8.1)

No statistical analyses for this end point

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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End point title

Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 ^[17] ^[18]

End point description

Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Exact 2-sided CI was based on the Clopper and Pearson method. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2
Number of subjects analysed	27	165	184	15	82	100	376	197
Units: Percentage of Participants
number (confidence interval 95%)	74.1 (53.7 to 88.9)	76.4 (69.1 to 82.6)	71.7 (64.6 to 78.1)	66.7 (38.4 to 88.2)	52.4 (41.1 to 63.6)	51.0 (40.8 to 61.1)	73.9 (69.2 to 78.3)	52.8 (45.6 to 59.9)

No statistical analyses for this end point

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

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End point title

Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044 ^[19] ^[20]

End point description

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSA Historical Control: All Age Groups	SSA Total Historical Control: C4591044 BNT162b2
Number of subjects analysed	26	167	186	15	85	100	379	200
Units: Percentage of participants
number (confidence interval 95%)	46.2 (26.6 to 66.6)	43.7 (36.1 to 51.6)	52.7 (45.3 to 60.0)	73.3 (44.9 to 92.2)	58.8 (47.6 to 69.4)	65.0 (54.8 to 74.3)	48.3 (43.2 to 53.4)	63.0 (55.9 to 69.7)

No statistical analyses for this end point

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB

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End point title

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB ^[21] ^[22]

End point description

Local reactions: pain at injection site, redness and swelling recorded by participants in an e-diary or as AEs in the CRF. Redness & swelling measured & recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm & were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) & Grade 4 (necrosis [swelling] & necrosis or exfoliative dermatitis [redness]). Pain at injection site graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) & G4 (ER visit or hospitalisation for severe pain at injection site). G4 LR classified by investigator or medically qualified person. Exact 2-sided CI based on Clopper and Pearson method. Safety population: all participants who received study intervention. Number of Participants Analysed= Participants evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSB: Group 3: >55 years	SSB Total Study Participants
Number of subjects analysed	9	250	49	308
Units: Percentage of Participants
number (confidence interval 95%)
Redness: Any	0 (0.0 to 33.6)	8.8 (5.6 to 13.0)	2.0 (0.1 to 10.9)	7.5 (4.8 to 11.0)
Redness: Mild	0 (0.0 to 33.6)	5.6 (3.1 to 9.2)	2.0 (0.1 to 10.9)	4.9 (2.8 to 7.9)
Redness: Moderate	0 (0.0 to 33.6)	2.8 (1.1 to 5.7)	0 (0.0 to 7.3)	2.3 (0.9 to 4.6)
Redness: Severe	0 (0.0 to 33.6)	0.4 (0.0 to 2.2)	0 (0.0 to 7.3)	0.3 (0.0 to 1.8)
Redness: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Swelling: Any	11.1 (0.3 to 48.2)	12.0 (8.2 to 16.7)	10.2 (3.4 to 22.2)	11.7 (8.3 to 15.8)
Swelling: Mild	11.1 (0.3 to 48.2)	6.8 (4.0 to 10.7)	8.2 (2.3 to 19.6)	7.1 (4.5 to 10.6)
Swelling: Moderate	0 (0.0 to 33.6)	5.2 (2.8 to 8.7)	2.0 (0.1 to 10.9)	4.5 (2.5 to 7.5)
Swelling: Severe	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Swelling: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Pain at the injection site: Any	44.4 (13.7 to 78.8)	58.0 (51.6 to 64.2)	36.7 (23.4 to 51.7)	54.2 (48.5 to 59.9)
Pain at the injection site: Mild	44.4 (13.7 to 78.8)	36.4 (30.4 to 42.7)	32.7 (19.9 to 47.5)	36.0 (30.7 to 41.7)
Pain at the injection site: Moderate	0 (0.0 to 33.6)	21.2 (16.3 to 26.8)	4.1 (0.5 to 14.0)	17.9 (13.7 to 22.6)
Pain at the injection site: Severe	0 (0.0 to 33.6)	0.4 (0.0 to 2.2)	0 (0.0 to 7.3)	0.3 (0.0 to 1.8)
Pain at the injection site: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)

No statistical analyses for this end point

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB

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End point title

Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB ^[23] ^[24]

End point description

Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 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 joint pain: mild (didn’t interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhoea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: All participants who received the study intervention. Number of Participants Analysed= Participants evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSB: Group 3: >55 years	SSB Total Study Participants
Number of subjects analysed	9	250	49	308
Units: Percentage of participants
number (confidence interval 95%)
Fever: Any	11.1 (0.3 to 48.2)	2.4 (0.9 to 5.2)	6.1 (1.3 to 16.9)	3.2 (1.6 to 5.9)
Fever: >=38.0 degree C to 38.4 degree C	0 (0.0 to 33.6)	0.8 (0.1 to 2.9)	4.1 (0.5 to 14.0)	1.3 (0.4 to 3.3)
Fever: >38.4 degree C to 38.9 degree C	11.1 (0.3 to 48.2)	1.2 (0.2 to 3.5)	0 (0.0 to 7.3)	1.3 (0.4 to 3.3)
Fever: >38.9 degree C to 40.0 degree C	0 (0.0 to 33.6)	0.4 (0.0 to 2.2)	2.0 (0.1 to 10.9)	0.6 (0.1 to 2.3)
Fever: >40.0 degree C	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Fatigue: Any	11.1 (0.3 to 48.2)	34.8 (28.9 to 41.1)	24.5 (13.3 to 38.9)	32.5 (27.3 to 38.0)
Fatigue: Mild	0 (0.0 to 33.6)	13.6 (9.6 to 18.5)	8.2 (2.3 to 19.6)	12.3 (8.9 to 16.5)
Fatigue: Moderate	11.1 (0.3 to 48.2)	21.2 (16.3 to 26.8)	16.3 (7.3 to 29.7)	20.1 (15.8 to 25.0)
Fatigue: Severe	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Fatigue: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Headache: Any	11.1 (0.3 to 48.2)	30.8 (25.1 to 36.9)	16.3 (7.3 to 29.7)	27.9 (23.0 to 33.3)
Headache: Mild	11.1 (0.3 to 48.2)	12.0 (8.2 to 16.7)	12.2 (4.6 to 24.8)	12.0 (8.6 to 16.2)
Headache: Moderate	0 (0.0 to 33.6)	18.0 (13.4 to 23.3)	4.1 (0.5 to 14.0)	15.3 (11.4 to 19.8)
Headache: Severe	0 (0.0 to 33.6)	0.8 (0.1 to 2.9)	0 (0.0 to 7.3)	0.6 (0.1 to 2.3)
Headache: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Chills: Any	11.1 (0.3 to 48.2)	12.0 (8.2 to 16.7)	10.2 (3.4 to 22.2)	11.7 (8.3 to 15.8)
Chills: Mild	11.1 (0.3 to 48.2)	7.2 (4.3 to 11.1)	4.1 (0.5 to 14.0)	6.8 (4.3 to 10.2)
Chills: Moderate	0 (0.0 to 33.6)	4.8 (2.5 to 8.2)	6.1 (1.3 to 16.9)	4.9 (2.8 to 7.9)
Chills: Severe	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Chills: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Vomiting: Any	0 (0.0 to 33.6)	4.8 (2.5 to 8.2)	2.0 (0.1 to 10.9)	4.2 (2.3 to 7.1)
Vomiting: Mild	0 (0.0 to 33.6)	2.4 (0.9 to 5.2)	2.0 (0.1 to 10.9)	2.3 (0.9 to 4.6)
Vomiting: Moderate	0 (0.0 to 33.6)	2.4 (0.9 to 5.2)	0 (0.0 to 7.3)	1.9 (0.7 to 4.2)
Vomiting: Severe	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Vomiting: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
Diarrhoea: Any	11.1 (0.3 to 48.2)	16.8 (12.4 to 22.0)	8.2 (2.3 to 19.6)	15.3 (11.4 to 19.8)
Diarrhoea: Mild	11.1 (0.3 to 48.2)	10.0 (6.6 to 14.4)	6.1 (1.3 to 16.9)	9.4 (6.4 to 13.2)
Diarrhoea: Moderate	0 (0.0 to 33.6)	6.4 (3.7 to 10.2)	2.0 (0.1 to 10.9)	5.5 (3.2 to 8.7)
Diarrhoea: Severe	0 (0.0 to 33.6)	0.4 (0.0 to 2.2)	0 (0.0 to 7.3)	0.3 (0.0 to 1.8)
Diarrhoea: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
New or worsened muscle pain: Any	11.1 (0.3 to 48.2)	18.0 (13.4 to 23.3)	18.4 (8.8 to 32.0)	17.9 (13.7 to 22.6)
New or worsened muscle pain: Mild	11.1 (0.3 to 48.2)	8.0 (5.0 to 12.1)	10.2 (3.4 to 22.2)	8.4 (5.6 to 12.1)
New or worsened muscle pain: Moderate	0 (0.0 to 33.6)	10.0 (6.6 to 14.4)	8.2 (2.3 to 19.6)	9.4 (6.4 to 13.2)
New or worsened muscle pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
New or worsened muscle pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
New or worsened joint pain: Any	11.1 (0.3 to 48.2)	12.8 (8.9 to 17.6)	12.2 (4.6 to 24.8)	12.7 (9.2 to 16.9)
New or worsened joint pain: Mild	11.1 (0.3 to 48.2)	6.4 (3.7 to 10.2)	6.1 (1.3 to 16.9)	6.5 (4.0 to 9.9)
New or worsened joint pain: Moderate	0 (0.0 to 33.6)	6.4 (3.7 to 10.2)	6.1 (1.3 to 16.9)	6.2 (3.8 to 9.5)
New or worsened joint pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)
New or worsened joint pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 1.5)	0 (0.0 to 7.3)	0 (0.0 to 1.2)

No statistical analyses for this end point

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB

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End point title

Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB ^[25] ^[26]

End point description

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from study vaccination on Day 1 up to 1 month after the study vaccination were reported in this endpoint. Exact 2-sided CI was based on 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 participants who received the study intervention.

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSB: Group 3: >55 years	SSB Total Study Participants
Number of subjects analysed	9	253	49	311
Units: Percentage of Participants
number (confidence interval 95%)	0 (0.0 to 33.6)	2.4 (0.9 to 5.1)	2.0 (0.1 to 10.9)	2.3 (0.9 to 4.6)

No statistical analyses for this end point

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB

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End point title

Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB ^[27] ^[28]

End point description

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 6 months after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSB: Group 3: >55 years	SSB Total Study Participants
Number of subjects analysed	9	253	49	311
Units: Percentage of participants
number (confidence interval 95%)	0 (0.0 to 33.6)	0.8 (0.1 to 2.8)	2.0 (0.1 to 10.9)	1.0 (0.2 to 2.8)

No statistical analyses for this end point

Primary: Difference in Percentages of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

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End point title

Difference in Percentages of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

End point description

Seroresponse was defined as achieving >= 4-fold rise from baseline. If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Percentage of participants with seroresponse is reported in descriptive section and percentage difference in statistical analysis section. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.

End point type

Primary

End point timeframe

At 1 month after vaccination

End point values	SSB: Vaccine-Naïve Substudy B	SSB Control: Vaccine-Experienced Substudy A
Number of subjects analysed	298	295
Units: Percentage of participants
number (confidence interval 95%)	84.9 (80.3 to 88.8)	73.9 (68.5 to 78.8)

Vaccine-Naïve SSB vs Vaccine-Experienced SSA

Statistical analysis description

2-Sided CI, based on the Miettinen and Nurminen method stratified by baseline neutralizing titer category (< median, >= median) and age group (< median, >= median). Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages was greater than -10%.

Comparison groups

SSB: Vaccine-Naïve Substudy B v SSB Control: Vaccine-Experienced Substudy A

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

Percentage Difference

Point estimate

7.31

Confidence interval

level

95%

sides

2-sided

lower limit

1.34

upper limit

13.28

Primary: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

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End point title

Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

End point description

GMTs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5*LLOQ. GMT is reported in descriptive section and GMR in statistical analysis section. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, Number of Participants Analysed signifies number of participants evaluable for this endpoint.

End point type

Primary

End point timeframe

At 1 month after vaccination

End point values	SSB: Vaccine-Naïve Substudy B	SSB Control: Vaccine-Experienced Substudy A
Number of subjects analysed	298	295
Units: Titer
geometric mean (confidence interval 95%)	4951.6 (4222.8 to 5806.2)	2566.5 (2186.8 to 3012.1)

Vaccine-Naïve SSB vs Vaccine-Experienced SSA

Statistical analysis description

GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the difference in LS means (Substudy B - Substudy A) and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Noninferiority of GMR was met if the lower limit of the 95% CI was greater than 0.67.

Comparison groups

SSB: Vaccine-Naïve Substudy B v SSB Control: Vaccine-Experienced Substudy A

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

Geometric mean ratio

Point estimate

1.93

Confidence interval

level

95%

sides

2-sided

lower limit

1.52

upper limit

2.44

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined

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End point title

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined ^[29] ^[30]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	92	106	216
Units: Percentage of participants
number (confidence interval 95%)
Redness: any	11.1 (1.4 to 34.7)	8.7 (3.8 to 16.4)	9.4 (4.6 to 16.7)	9.3 (5.7 to 13.9)
Redness: mild	5.6 (0.1 to 27.3)	1.1 (0.0 to 5.9)	6.6 (2.7 to 13.1)	4.2 (1.9 to 7.8)
Redness: moderate	5.6 (0.1 to 27.3)	6.5 (2.4 to 13.7)	2.8 (0.6 to 8.0)	4.6 (2.2 to 8.3)
Redness: severe	0 (0.0 to 18.5)	1.1 (0.0 to 5.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
Redness: grade 4	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
Swelling: any	0 (0.0 to 18.5)	13.0 (6.9 to 21.7)	11.3 (6.0 to 18.9)	11.1 (7.3 to 16.1)
Swelling: mild	0 (0.0 to 18.5)	8.7 (3.8 to 16.4)	4.7 (1.5 to 10.7)	6.0 (3.2 to 10.1)
Swelling: moderate	0 (0.0 to 18.5)	4.3 (1.2 to 10.8)	6.6 (2.7 to 13.1)	5.1 (2.6 to 8.9)
Swelling: severe	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
Swelling: grade 4	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
Pain at the injection site: any	88.9 (65.3 to 98.6)	72.8 (62.6 to 81.6)	49.1 (39.2 to 59.0)	62.5 (55.7 to 69.0)
Pain at the injection site: mild	55.6 (30.8 to 78.5)	58.7 (47.9 to 68.9)	42.5 (32.9 to 52.4)	50.5 (43.6 to 57.3)
Pain at the injection site: moderate	27.8 (9.7 to 53.5)	12.0 (6.1 to 20.4)	5.7 (2.1 to 11.9)	10.2 (6.5 to 15.0)
Pain at the injection site: severe	5.6 (0.1 to 27.3)	2.2 (0.3 to 7.6)	0.9 (0.0 to 5.1)	1.9 (0.5 to 4.7)
Pain at the injection site: grade 4	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)

No statistical analyses for this end point

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined

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End point title

Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined ^[31] ^[32]

End point description

Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 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 joint pain: mild (didn’t interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhoea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: All participants who received the study intervention. Here "n" signifies participants evaluable at specific event.

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	92	106	216
Units: Percentage of participants
number (confidence interval 95%)
Fever: any(n=18, 92, 104, 214)	11.1 (1.4 to 34.7)	4.3 (1.2 to 10.8)	1.9 (0.2 to 6.8)	3.7 (1.6 to 7.2)
Fever:>=38.0deg C to38.4deg C(n=18, 92, 104, 214)	5.6 (0.1 to 27.3)	2.2 (0.3 to 7.6)	1.0 (0.0 to 5.2)	1.9 (0.5 to 4.7)
Fever:>38.4 degC to 38.9 deg C(n=18, 92, 104,214)	5.6 (0.1 to 27.3)	2.2 (0.3 to 7.6)	0 (0.0 to 3.5)	1.4 (0.3 to 4.0)
Fever: >38.9 degC to40.0 degC(n=18, 92, 104, 214)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	1.0 (0.0 to 5.2)	0.5 (0.0 to 2.6)
Fever: >40.0 degree C(n=18, 92, 104, 214)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.5)	0 (0.0 to 1.7)
Fatigue: any (n=18,92,106,216)	55.6 (30.8 to 78.5)	47.8 (37.3 to 58.5)	29.2 (20.8 to 38.9)	39.4 (32.8 to 46.2)
Fatigue: mild(n=18,92,106,216)	11.1 (1.4 to 34.7)	22.8 (14.7 to 32.8)	17.0 (10.4 to 25.5)	19.0 (14.0 to 24.9)
Fatigue: moderate (n=18,92,106,216)	38.9 (17.3 to 64.3)	25.0 (16.6 to 35.1)	11.3 (6.0 to 18.9)	19.4 (14.4 to 25.4)
Fatigue: severe (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0.9 (0.0 to 5.1)	0.5 (0.0 to 2.6)
Fatigue: grade 4 (n=18,92,106,216)	5.6 (0.1 to 27.3)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
Headache: any (n=18,92,106,216)	61.1 (35.7 to 82.7)	35.9 (26.1 to 46.5)	17.9 (11.2 to 26.6)	29.2 (23.2 to 35.7)
Headache: mild (n=18,92,106,216)	44.4 (21.5 to 69.2)	21.7 (13.8 to 31.6)	13.2 (7.4 to 21.2)	19.4 (14.4 to 25.4)
Headache: moderate (n=18,92,106,216)	11.1 (1.4 to 34.7)	13.0 (6.9 to 21.7)	3.8 (1.0 to 9.4)	8.3 (5.0 to 12.9)
Headache: severe (n=18,92,106,216)	0 (0.0 to 18.5)	1.1 (0.0 to 5.9)	0.9 (0.0 to 5.1)	0.9 (0.1 to 3.3)
Headache: grade 4 (n=18,92,106,216)	5.6 (0.1 to 27.3)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
Chills: any (n=18,92,106,216)	44.4 (21.5 to 69.2)	17.4 (10.3 to 26.7)	8.5 (4.0 to 15.5)	15.3 (10.8 to 20.8)
Chills: mild (n=18,92,106,216)	27.8 (9.7 to 53.5)	10.9 (5.3 to 19.1)	4.7 (1.5 to 10.7)	9.3 (5.7 to 13.9)
Chills: moderate (n=18,92,106,216)	11.1 (1.4 to 34.7)	6.5 (2.4 to 13.7)	2.8 (0.6 to 8.0)	5.1 (2.6 to 8.9)
Chills: severe (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0.9 (0.0 to 5.1)	0.5 (0.0 to 2.6)
Chills: grade 4 (n=18,92,106,216)	5.6 (0.1 to 27.3)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
Vomiting: any (n=18,92,106,216)	11.1 (1.4 to 34.7)	2.2 (0.3 to 7.6)	0.9 (0.0 to 5.1)	2.3 (0.3 to 5.3)
Vomiting: mild (n=18,92,106,216)	5.6 (0.1 to 27.3)	2.2 (0.3 to 7.6)	0 (0.0 to 3.4)	1.4 (0.3 to 4.0)
Vomiting: moderate (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0.9 (0.0 to 5.1)	0.5 (0.0 to 2.6)
Vomiting: severe (n=18,92,106,216)	5.6 (0.1 to 27.3)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
Vomiting: grade 4 (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
Diarrhoea: any (n=18,92,106,216)	0 (0.0 to 18.5)	9.8 (4.6 to 17.8)	7.5 (3.3 to 14.3)	7.9 (4.7 to 12.3)
Diarrhoea: mild (n=18,92,106,216)	0 (0.0 to 18.5)	6.5 (2.4 to 13.7)	6.6 (2.7 to 13.1)	6.0 (3.2 to 10.1)
Diarrhoea: moderate (n=18,92,106,216)	0 (0.0 to 18.5)	3.3 (0.7 to 9.2)	0.9 (0.0 to 5.1)	1.9 (0.5 to 4.7)
Diarrhoea: severe (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
Diarrhoea: grade 4 (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
New/worsened muscle pain: any (n=18,92,106,216)	33.3 (13.3 to 59.0)	17.4 (10.3 to 26.7)	10.4 (5.3 to 17.8)	15.3 (10.8 to 20.8)
New/worsened muscle pain:mild (n=18,92,106,216)	16.7 (3.6 to 41.4)	8.7 (3.8 to 16.4)	5.7 (2.1 to 11.9)	7.9 (4.7 to 12.3)
New/worsened muscle pain:moderate(n=18,92,106,216	11.1 (1.4 to 34.7)	8.7 (3.8 to 16.4)	4.7 (1.5 to 10.7)	6.9 (3.9 to 11.2)
New/worsened muscle pain:severe(n=18,92,106,216	5.6 (0.1 to 27.3)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
New or worsened muscle pain: g4 (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)
New or worsened joint pain: any (n=18,92,106,216)	11.1 (1.4 to 34.7)	8.7 (3.8 to 16.4)	7.5 (3.3 to 14.3)	8.3 (5.0 to 12.9)
New or worsened joint pain:mild (n=18,92,106,216)	5.6 (0.1 to 27.3)	6.5 (2.4 to 13.7)	3.8 (1.0 to 9.4)	5.1 (2.6 to 8.9)
New/worsened joint pain:moderate(n=18,92,106,216)	0 (0.0 to 18.5)	2.2 (0.3 to 7.6)	3.8 (1.0 to 9.4)	2.8 (1.0 to 5.9)
New/worsened joint pain: severe (n=18,92,106,216)	5.6 (0.1 to 27.3)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0.5 (0.0 to 2.6)
New or worsened joint pain: g4 (n=18,92,106,216)	0 (0.0 to 18.5)	0 (0.0 to 3.9)	0 (0.0 to 3.4)	0 (0.0 to 1.7)

No statistical analyses for this end point

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 1 and Cohort 2 Combined

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End point title

Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 1 and Cohort 2 Combined ^[33] ^[34]

End point description

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. Percentage of participants reporting AEs from study vaccination on Day 1 up to 1 month after the study vaccination were reported in this outcome measure. Exact 2-sided CI was based on Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure. Safety population: All participants who received the study intervention.

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	92	106	216
Units: Percentage of participants
number (confidence interval 95%)	5.6 (0.1 to 27.3)	3.3 (0.7 to 9.2)	8.5 (4.0 to 15.5)	6.0 (3.2 to 10.1)

No statistical analyses for this end point

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 1 and Cohort 2 Combined

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End point title

Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 1 and Cohort 2 Combined ^[35] ^[36]

End point description

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; or considered as an important medical event. Percentage of participants reporting SAEs from study vaccination on Day 1 up to 6 months after the study vaccination were reported in this outcome measure. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: all participants who received study intervention.

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 6 months after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	92	106	216
Units: Percentage of participants
number (confidence interval 95%)	0 (0.0 to 18.5)	1.1 (0.0 to 5.9)	2.8 (0.6 to 8.0)	1.9 (0.5 to 4.7)

No statistical analyses for this end point

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3

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End point title

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3 ^[37] ^[38]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups
Number of subjects analysed	51	51	102
Units: Percentage of participants
number (confidence interval 95%)
Redness: any	5.9 (1.2 to 16.2)	2.0 (0.0 to 10.4)	3.9 (1.1 to 9.7)
Redness: mild	2.0 (0.0 to 10.4)	2.0 (0.0 to 10.4)	2.0 (0.2 to 6.9)
Redness: moderate	3.9 (0.5 to 13.5)	0 (0.0 to 7.0)	2.0 (0.2 to 6.9)
Redness: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Redness: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Swelling: any	9.8 (3.3 to 21.4)	3.9 (0.5 to 13.5)	6.9 (2.8 to 13.6)
Swelling: mild	3.9 (0.5 to 13.5)	3.9 (0.5 to 13.5)	3.9 (1.1 to 9.7)
Swelling: moderate	5.9 (1.2 to 16.2)	0 (0.0 to 7.0)	2.9 (0.6 to 8.4)
Swelling: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Swelling: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Pain at the injection site: any	72.5 (58.3 to 84.1)	45.1 (31.1 to 59.7)	58.8 (48.6 to 68.5)
Pain at the injection site: mild	60.8 (46.1 to 74.2)	39.2 (25.8 to 53.9)	50.0 (39.9 to 60.1)
Pain at the injection site: moderate	11.8 (4.4 to 23.9)	5.9 (1.2 to 16.2)	8.8 (4.1 to 16.1)
Pain at the injection site: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Pain at the injection site: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)

No statistical analyses for this end point

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3

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End point title

Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3 ^[39] ^[40]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups
Number of subjects analysed	51	51	102
Units: Percentage of participants
number (confidence interval 95%)
Fever: any	3.9 (0.5 to 13.5)	3.9 (0.5 to 13.5)	3.9 (1.1 to 9.7)
Fever: >=38.0 degree C to 38.4 degree C	3.9 (0.5 to 13.5)	2.0 (0.0 to 10.4)	2.9 (0.6 to 8.4)
Fever: >38.4 degree C to 38.9 degree C	0 (0.0 to 7.0)	2.0 (0.0 to 10.4)	1.0 (0.0 to 5.3)
Fever: >38.9 degree C to 40.0 degree C	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Fever: >40.0 degree C	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Fatigue: any	58.8 (44.2 to 72.4)	33.3 (20.8 to 47.9)	46.1 (36.2 to 56.2)
Fatigue: mild	33.3 (20.8 to 47.9)	19.6 (9.8 to 33.1)	26.5 (18.2 to 36.1)
Fatigue: moderate	25.5 (14.3 to 39.6)	13.7 (5.7 to 26.3)	19.6 (12.4 to 28.6)
Fatigue: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Fatigue: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Headache: any	39.2 (25.8 to 53.9)	17.6 (8.4 to 30.9)	28.4 (19.9 to 38.2)
Headache: mild	27.5 (15.9 to 41.7)	11.8 (4.4 to 23.9)	19.6 (12.4 to 28.6)
Headache: moderate	11.8 (4.4 to 23.9)	5.9 (1.2 to 16.2)	8.8 (4.1 to 16.1)
Headache: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Headache: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Chills: any	7.8 (2.2 to 18.9)	9.8 (3.3 to 21.4)	8.8 (4.1 to 16.1)
Chills: mild	3.9 (0.5 to 13.5)	9.8 (3.3 to 21.4)	6.9 (2.8 to 13.6)
Chills: moderate	3.9 (0.5 to 13.5)	0 (0.0 to 7.0)	2.0 (0.2 to 6.9)
Chills: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Chills: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Vomiting: any	2.0 (0.0 to 10.4)	3.9 (0.5 to 13.5)	2.9 (0.6 to 8.4)
Vomiting: mild	2.0 (0.0 to 10.4)	2.0 (0.0 to 10.4)	2.0 (0.2 to 6.9)
Vomiting: moderate	0 (0.0 to 7.0)	2.0 (0.0 to 10.4)	1.0 (0.0 to 5.3)
Vomiting: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Vomiting: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Diarrhoea: any	11.8 (4.4 to 23.9)	7.8 (2.2 to 18.9)	9.8 (4.8 to 17.3)
Diarrhoea: mild	7.8 (2.2 to 18.9)	7.8 (2.2 to 18.9)	7.8 (3.4 to 14.9)
Diarrhoea: moderate	3.9 (0.5 to 13.5)	0 (0.0 to 7.0)	2.0 (0.2 to 6.9)
Diarrhoea: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
Diarrhoea: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
New or worsened muscle pain: any	33.3 (20.8 to 47.9)	9.8 (3.3 to 21.4)	21.6 (14.0 to 30.8)
New or worsened muscle pain: mild	17.6 (8.4 to 30.9)	7.8 (2.2 to 18.9)	12.7 (7.0 to 20.8)
New or worsened muscle pain: moderate	15.7 (7.0 to 28.6)	2.0 (0.0 to 10.4)	8.8 (4.1 to 16.1)
New or worsened muscle pain: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
New or worsened muscle pain: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
New or worsened joint pain: any	13.7 (5.7 to 26.3)	3.9 (0.5 to 13.5)	8.8 (4.1 to 16.1)
New or worsened joint pain: mild	11.8 (4.4 to 23.9)	2.0 (0.0 to 10.4)	6.9 (2.8 to 13.6)
New or worsened joint pain: moderate	2.0 (0.0 to 10.4)	2.0 (0.0 to 10.4)	2.0 (0.2 to 6.9)
New or worsened joint pain: severe	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)
New or worsened joint pain: grade 4	0 (0.0 to 7.0)	0 (0.0 to 7.0)	0 (0.0 to 3.6)

No statistical analyses for this end point

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3

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End point title

Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3 ^[41] ^[42]

End point description

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups
Number of subjects analysed	51	51	102
Units: Percentage of participants
number (confidence interval 95%)	13.7 (5.7 to 26.3)	5.9 (1.2 to 16.2)	9.8 (4.8 to 17.3)

No statistical analyses for this end point

Primary: GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

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End point title

GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively ^[43] ^[44]

End point description

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "n" signifies participants evaluable at specific variant.

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSA Total Study Participants: C4591054	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	91	103	200	17	85	98	212
Units: Titers
geometric mean (confidence interval 95%)
Omicron JN.1(n=18,91,103,212,17,84,98,199)	3920.4 (2296.3 to 6693.2)	1895.8 (1456.8 to 2467.0)	2275.2 (1771.0 to 2923.1)	1133.8 (950.7 to 1352.2)	1979.1 (928.5 to 4218.1)	1060.1 (841.8 to 1335.1)	1090.4 (829.7 to 1433.1)	2203.3 (1855.7 to 2616.0)
Omicron XBB.1.5(n=18,91,103,212,17,85,98,200)	5893.1 (3472.2 to 10002.0)	1926.7 (1361.8 to 2725.9)	2415.2 (1815.5 to 3213.1)	2848.1 (2341.9 to 3463.8)	5744.9 (3040.8 to 10853.8)	2566.8 (1963.2 to 3355.9)	2759.8 (2028.9 to 3753.9)	2364.4 (1917.4 to 2915.6)

No statistical analyses for this end point

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3

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End point title

Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3 ^[45] ^[46]

End point description

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; or considered as an important medical event. Percentage of participants reporting SAEs from study vaccination on Day 1 up to 6 months after the study vaccination were reported in this outcome measure. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: all participants who received study intervention.

End point type

Primary

End point timeframe

From vaccination on Day 1 up to 6 months after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups
Number of subjects analysed	51	51	102
Units: Percentage of participants
number (confidence interval 95%)	0 (0.0 to 7.0)	2.0 (0.0 to 10.4)	1.0 (0.0 to 5.3)

No statistical analyses for this end point

Primary: GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

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End point title

GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively ^[47] ^[48]

End point description

GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "n" signifies participants evaluable for specific variant.

End point type

Primary

End point timeframe

From before vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSA Total Study Participants: C4591054	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	91	103	200	17	85	98	212
Units: Fold rise
geometric mean (confidence interval 95%)
Omicron JN.1 (n=17,91,103,211,17,83,97,197)	15.5 (5.8 to 41.5)	11.2 (8.3 to 15.0)	11.4 (8.4 to 15.4)	7.2 (6.0 to 8.7)	3.9 (2.5 to 6.1)	5.8 (4.5 to 7.6)	9.6 (7.2 to 12.9)	11.6 (9.4 to 14.2)
Omicron XBB.1.5 (n=18,91,103,212,17,85,98,200)	15.9 (6.3 to 40.1)	7.0 (5.0 to 9.8)	8.3 (6.0 to 11.4)	13.0 (10.9 to 15.5)	10.2 (6.2 to 16.8)	12.3 (9.4 to 16.1)	14.2 (11.0 to 18.4)	8.1 (6.5 to 10.2)

No statistical analyses for this end point

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

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End point title

Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively ^[49] ^[50]

End point description

Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "n" signifies participants evaluable for specific variant.

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSA Total Study Participants: C4591054	SSA Historical Control: 12-17 years	SSA Historical Control: 18-55 years	SSA Historical Control: >55 years	SSC: Cohort 1 and Cohort 2 Combined: All Age Groups
Number of subjects analysed	18	91	103	200	17	85	98	212
Units: Percentage of participants
number (confidence interval 95%)
Omicron JN.1 (n=17,91,103,211,17,83,97,197)	70.6 (44.0 to 89.7)	73.6 (63.3 to 82.3)	68.0 (58.0 to 76.8)	65.5 (58.4 to 72.1)	47.1 (23.0 to 72.2)	63.9 (52.6 to 74.1)	70.1 (60.0 to 79.0)	70.6 (64.0 to 76.7)
Omicron XBB.1.5 (n=18,91,103,212,17,85,98,200)	66.7 (41.0 to 86.7)	58.2 (47.4 to 68.5)	61.2 (51.1 to 70.6)	82.0 (76.0 to 87.1)	82.4 (56.6 to 96.2)	82.4 (72.6 to 89.8)	81.6 (72.5 to 88.7)	60.4 (53.5 to 67.0)

No statistical analyses for this end point

Primary: GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

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End point title

GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined ^[51] ^[52]

End point description

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. SSC combined cohorts 1 and 2 acted as control for this outcome measure.

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups	SSC Cohort 1 and Cohort 2 Combined BNT162b2
Number of subjects analysed	91	103	50	50	100	194
Units: Titer
geometric mean (confidence interval 95%)
Omicron KP.2	890.4 (648.6 to 1222.2)	858.5 (641.5 to 1148.8)	2037.8 (1326.3 to 3130.9)	2498.8 (1590.4 to 3926.0)	2256.5 (1660.2 to 3067.0)	873.3 (706.1 to 1080.2)
Omicron JN.1	1895.8 (1456.8 to 2467.0)	2275.2 (1771.0 to 2923.1)	3738.8 (2566.9 to 5445.6)	4990.5 (3309.3 to 7525.7)	4319.5 (3280.7 to 5687.2)	2088.6 (1743.9 to 2501.5)

No statistical analyses for this end point

Primary: GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

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End point title

GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined ^[53] ^[54]

End point description

GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician . SSC combined cohorts 1 and 2 acted as control for this outcome measure.

End point type

Primary

End point timeframe

From before vaccination on Day 1 up to 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups	SSC Cohort 1 and Cohort 2 Combined BNT162b2
Number of subjects analysed	91	103	50	50	100	194
Units: Fold rise
geometric mean (confidence interval 95%)
Omicron KP.2 (n=49,50,91,103,99,194)	11.4 (8.5 to 15.4)	10.9 (8.1 to 14.7)	8.9 (6.3 to 12.5)	13.4 (8.1 to 22.1)	11.0 (8.1 to 14.8)	11.1 (9.0 to 13.7)
Omicron JN.1 (n=50,50,91,103,100,194)	11.2 (8.3 to 15.0)	11.4 (8.4 to 15.4)	6.6 (4.7 to 9.2)	11.7 (6.7 to 20.3)	8.8 (6.4 to 12.1)	11.3 (9.1 to 13.9)

No statistical analyses for this end point

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

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End point title

Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined ^[55] ^[56]

End point description

End point type

Primary

End point timeframe

At 1 month after vaccination

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: Only descriptive data was planned to be analyzed for this endpoint.
[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 endpoint was planned to be analysed only for the specified reporting arms

End point values	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSC: Cohort 3: > 55 Years	SSC: Cohort 3 Combined: All Age Groups	SSC Cohort 1 and Cohort 2 Combined BNT162b2
Number of subjects analysed	91	103	49	50	99	194
Units: Percentage of participants
number (confidence interval 95%)
Omicron KP.2 (n=49,50,91,103,99,194)	71.4 (61.0 to 80.4)	63.1 (53.0 to 72.4)	77.6 (63.4 to 88.2)	76.0 (61.8 to 86.9)	76.8 (67.2 to 84.7)	67.0 (59.9 to 73.6)
Omicron JN.1 (n=50,50,91,103,100,194)	73.6 (63.3 to 82.3)	68.0 (58.0 to 76.8)	64.0 (49.2 to 77.1)	64.0 (49.2 to 77.1)	64.0 (53.8 to 73.4)	70.6 (63.7 to 76.9)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

SSA,B&C: Systematic assessment (SA): Local reactions, systemic events: Day 1 to 7 after vaccination(vax); Non-SA: SAEs (including all cause mortality): Day 1 of vax up to 6 months after study vax & Non-SAEs: Day 1 of vax up to 1 month after study vax

Adverse event reporting additional description

Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all participants who received the study intervention.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.1

Reporting group title

SSA: Group 1: 12-17 years

Reporting group description

Reporting group title

SSA: Group 2: 18-55 years

Reporting group description

Reporting group title

SSA: Group 3: >55 years

Reporting group description

Reporting group title

SSB: Group 1: 12-17 years

Reporting group description

Reporting group title

SSB: Group 2: 18-55 years

Reporting group description

Participants aged 18-55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 3: > 55 Years

Reporting group description

Participants aged >55 years were randomized to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years

Reporting group description

Participants aged 12-17 years were randomized to receive a single dose of BNT162b2 (Omi JN.1)30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years

Reporting group description

Participants aged 18-55 years were randomized to receive a single dose of BNT162b2 (Omi JN.1)30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 1 and Cohort 2 Combined: > 55 Years

Reporting group description

Participants aged >55 years were randomized to receive a single dose of BNT162b2 (Omi JN.1)30 mcg via IM route on Day 1 of this study.

Reporting group title

SSC: Cohort 3: 18-55 Years

Reporting group description

Participants aged 18-55 years were randomized to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.

Reporting group title

SSB: Group 3: >55 years

Reporting group description

Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine–naïve received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.

Serious adverse events	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSC: Cohort 3: > 55 Years	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSB: Group 3: >55 years
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	4 / 208 (1.92%)	0 / 9 (0.00%)	2 / 253 (0.79%)	1 / 51 (1.96%)	0 / 18 (0.00%)	1 / 92 (1.09%)	3 / 106 (2.83%)	0 / 51 (0.00%)	1 / 49 (2.04%)
number of deaths (all causes)	0	0	1	0	0	0	0	0	1	0	0
number of deaths resulting from adverse events	0	0	1	0	0	0	0	0	1	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Injury, poisoning and procedural complications
Cervical vertebral fracture
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	1 / 106 (0.94%)	0 / 51 (0.00%)	0 / 49 (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 / 1	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
Road traffic accident
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	1 / 106 (0.94%)	0 / 51 (0.00%)	0 / 49 (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 / 1	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
Subdural haematoma
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	1 / 106 (0.94%)	0 / 51 (0.00%)	0 / 49 (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 / 1	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
Cardiac disorders
Cardiac arrest
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
deaths 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
Nervous system disorders
Cerebrovascular accident
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	1 / 51 (1.96%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Gastrointestinal disorders
Small intestinal obstruction
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	1 / 49 (2.04%)
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 / 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
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Dyspnoea
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	1 / 253 (0.40%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	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
Respiratory failure
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	1 / 106 (0.94%)	0 / 51 (0.00%)	0 / 49 (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 / 1	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	1 / 1	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Paroxysmal nocturnal haemoglobinuria
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Infections and infestations
Cellulitis
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Appendicitis
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	1 / 253 (0.40%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	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
Viral infection
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	1 / 106 (0.94%)	0 / 51 (0.00%)	0 / 49 (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 / 1	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
Diverticulitis
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 92 (1.09%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Metabolism and nutrition disorders
Hyponatraemia
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (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
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
Dehydration
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	1 / 106 (0.94%)	0 / 51 (0.00%)	0 / 49 (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 / 1	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

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	SSA: Group 1: 12-17 years	SSA: Group 2: 18-55 years	SSA: Group 3: >55 years	SSB: Group 1: 12-17 years	SSB: Group 2: 18-55 years	SSC: Cohort 3: > 55 Years	SSC: Cohort 1 and Cohort 2 Combined: 12-17 Years	SSC: Cohort 1 and Cohort 2 Combined: 18-55 Years	SSC: Cohort 1 and Cohort 2 Combined: > 55 Years	SSC: Cohort 3: 18-55 Years	SSB: Group 3: >55 years
Total subjects affected by non serious adverse events
subjects affected / exposed	27 / 30 (90.00%)	154 / 174 (88.51%)	134 / 208 (64.42%)	4 / 9 (44.44%)	167 / 253 (66.01%)	35 / 51 (68.63%)	16 / 18 (88.89%)	77 / 92 (83.70%)	66 / 106 (62.26%)	43 / 51 (84.31%)	25 / 49 (51.02%)
Nervous system disorders
Restless arm syndrome
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Headache (HEADACHE)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	11 / 30 (36.67%)	76 / 174 (43.68%)	54 / 208 (25.96%)	1 / 9 (11.11%)	76 / 253 (30.04%)	9 / 51 (17.65%)	11 / 18 (61.11%)	33 / 92 (35.87%)	19 / 106 (17.92%)	20 / 51 (39.22%)	8 / 49 (16.33%)
occurrences all number	11	76	54	1	76	9	11	33	19	20	8
Dizziness
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Headache
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	1 / 51 (1.96%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Somnolence
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Blood and lymphatic system disorders
Lymphadenopathy
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	2 / 174 (1.15%)	0 / 208 (0.00%)	0 / 9 (0.00%)	1 / 253 (0.40%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 92 (1.09%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	2	0	0	1	0	0	1	0	0	0
General disorders and administration site conditions
Axillary pain
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative dictionary used: MedDRA 27.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 92 (1.09%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Injection site erythema (REDNESS)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	3 / 30 (10.00%)	7 / 174 (4.02%)	12 / 208 (5.77%)	0 / 9 (0.00%)	0 / 253 (0.00%)	1 / 51 (1.96%)	2 / 18 (11.11%)	8 / 92 (8.70%)	10 / 106 (9.43%)	3 / 51 (5.88%)	0 / 49 (0.00%)
occurrences all number	3	7	12	0	0	1	2	8	10	3	0
Fatigue (FATIGUE)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	17 / 30 (56.67%)	99 / 174 (56.90%)	73 / 208 (35.10%)	1 / 9 (11.11%)	87 / 253 (34.39%)	17 / 51 (33.33%)	10 / 18 (55.56%)	44 / 92 (47.83%)	31 / 106 (29.25%)	30 / 51 (58.82%)	12 / 49 (24.49%)
occurrences all number	17	99	73	1	87	17	10	44	31	30	12
Fatigue
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	2 / 174 (1.15%)	2 / 208 (0.96%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 92 (1.09%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	2	2	0	0	0	0	1	0	0	0
Chills (CHILLS)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	6 / 30 (20.00%)	16 / 174 (9.20%)	19 / 208 (9.13%)	1 / 9 (11.11%)	30 / 253 (11.86%)	5 / 51 (9.80%)	8 / 18 (44.44%)	16 / 92 (17.39%)	9 / 106 (8.49%)	4 / 51 (7.84%)	5 / 49 (10.20%)
occurrences all number	6	16	19	1	30	5	8	16	9	4	5
Pyrexia
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 92 (1.09%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Injection site pruritus
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 92 (1.09%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	0
Injection site swelling (SWELLING)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	5 / 30 (16.67%)	13 / 174 (7.47%)	12 / 208 (5.77%)	1 / 9 (11.11%)	30 / 253 (11.86%)	2 / 51 (3.92%)	0 / 18 (0.00%)	12 / 92 (13.04%)	12 / 106 (11.32%)	5 / 51 (9.80%)	5 / 49 (10.20%)
occurrences all number	5	13	12	1	30	2	0	12	12	5	5
Pyrexia (FEVER)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	5 / 30 (16.67%)	7 / 174 (4.02%)	8 / 208 (3.85%)	1 / 9 (11.11%)	6 / 253 (2.37%)	2 / 51 (3.92%)	2 / 18 (11.11%)	4 / 92 (4.35%)	2 / 106 (1.89%)	2 / 51 (3.92%)	3 / 49 (6.12%)
occurrences all number	5	7	8	1	6	2	2	4	2	2	3
Injection site pain (PAIN)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	24 / 30 (80.00%)	132 / 174 (75.86%)	107 / 208 (51.44%)	4 / 9 (44.44%)	142 / 253 (56.13%)	23 / 51 (45.10%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	37 / 51 (72.55%)	18 / 49 (36.73%)
occurrences all number	24	132	107	4	142	23	0	0	0	37	18
Injection site pain
alternative dictionary used: MedDRA 27.1
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	4 / 208 (1.92%)	0 / 9 (0.00%)	5 / 253 (1.98%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	4	0	5	0	0	0	0	0	0
Non-cardiac chest pain
alternative dictionary used: MedDRA 27.1
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	2 / 174 (1.15%)	1 / 208 (0.48%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	2	1	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
Vertigo
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	1 / 51 (1.96%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Ear disorder
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Ear pain
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Gastrointestinal disorders
Vomiting (VOMITING)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	4 / 174 (2.30%)	0 / 208 (0.00%)	0 / 9 (0.00%)	12 / 253 (4.74%)	2 / 51 (3.92%)	2 / 18 (11.11%)	2 / 92 (2.17%)	1 / 106 (0.94%)	1 / 51 (1.96%)	1 / 49 (2.04%)
occurrences all number	0	4	0	0	12	2	2	2	1	1	1
Gastrooesophageal reflux disease
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	2 / 174 (1.15%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0
Diarrhoea (DIARRHEA)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	21 / 174 (12.07%)	18 / 208 (8.65%)	1 / 9 (11.11%)	42 / 253 (16.60%)	4 / 51 (7.84%)	0 / 18 (0.00%)	9 / 92 (9.78%)	8 / 106 (7.55%)	6 / 51 (11.76%)	4 / 49 (8.16%)
occurrences all number	0	21	18	1	42	4	0	9	8	6	4
Diarrhoea
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	3 / 174 (1.72%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0
Abdominal pain upper
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Reproductive system and breast disorders
Breast tenderness
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Dysmenorrhoea
alternative dictionary used: MedDRA 27.1
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Heavy menstrual bleeding
alternative dictionary used: MedDRA 27.1
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
Depression
alternative dictionary used: MedDRA 27.1
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	7 / 30 (23.33%)	38 / 174 (21.84%)	25 / 208 (12.02%)	1 / 9 (11.11%)	45 / 253 (17.79%)	5 / 51 (9.80%)	6 / 18 (33.33%)	16 / 92 (17.39%)	11 / 106 (10.38%)	17 / 51 (33.33%)	9 / 49 (18.37%)
occurrences all number	7	38	25	1	45	5	6	16	11	17	9
Back pain
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	1 / 51 (1.96%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Arthralgia (JOINT PAIN)
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	5 / 30 (16.67%)	25 / 174 (14.37%)	16 / 208 (7.69%)	1 / 9 (11.11%)	32 / 253 (12.65%)	2 / 51 (3.92%)	2 / 18 (11.11%)	8 / 92 (8.70%)	8 / 106 (7.55%)	7 / 51 (13.73%)	6 / 49 (12.24%)
occurrences all number	5	25	16	1	32	2	2	8	8	7	6
Pain in extremity
alternative dictionary used: MedDRA 27.1
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	1 / 49 (2.04%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Infections and infestations
Sialoadenitis
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Pneumonia
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Conjunctivitis
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Sinusitis
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	2 / 51 (3.92%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0
Ear infection
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	0 / 30 (0.00%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	2 / 51 (3.92%)	0 / 49 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0
Metabolism and nutrition disorders
Decreased appetite
Additional description: MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
subjects affected / exposed	1 / 30 (3.33%)	0 / 174 (0.00%)	0 / 208 (0.00%)	0 / 9 (0.00%)	0 / 253 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 92 (0.00%)	0 / 106 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

10 Mar 2024

This protocol was amended due to the addition of Substudy C to evaluate the BNT162b2 vaccine targeting the SARS-CoV-2 variant selected for the 2024-2025 respiratory virus season.

06 Aug 2024

This protocol was amended to add Cohort 3 to Substudy C to evaluate the BNT162b2 (Omi KP.2) vaccine. Cohort 1 was also modified to remove the planned second investigational vaccine, since the evaluation is performed in Cohort 3 instead.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 2/3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA - Based Vaccine Candidates for SARS-Cov-2 New Variants in Healthy Individuals

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

Primary: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA

Primary: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA

Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Through 6 Months After the Study Vaccination: SSA

Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Through 6 Months After the Study Vaccination: SSA

Primary: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group from Study C4591044

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB

Primary: Difference in Percentages of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

Primary: Difference in Percentages of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

Primary: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

Primary: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5): COVID-19 Vaccine-Naïve Participants in SSB Versus Vaccine-Experienced Participants in SSA

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 1 and Cohort 2 Combined

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3

Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3

Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3

Primary: Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3

Primary: GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

Primary: GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3

Primary: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3

Primary: GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

Primary: GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA Respectively

Primary: GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

Primary: GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

Primary: GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

Primary: GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

Primary: Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2/3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA - Based Vaccine Candidates for SARS-Cov-2 New Variants in Healthy Individuals