Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And Efficacy Of Sars-Cov-2 RNA Vaccine Candidates Against Covid-19 In Healthy Individuals

    Summary
    EudraCT number
    2020-002641-42
    Trial protocol
    DE  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    v1
    This version publication date
    26 Aug 2023
    First version publication date
    26 Aug 2023
    Other versions
    v2

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    C4591001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04368728
    WHO universal trial number (UTN)
    -
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002861-PIP02-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase 1: To describe safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses. Phase 2/3: To evaluate efficacy of prophylactic BNT162b2 against confirmed COVID-19 occurring from 7 days after second dose in subjects without evidence of infection before vaccination and in subjects with or without evidence of infection before vaccination; To define the safety profile of prophylactic BNT162b2 in the first 360 subjects randomized (Phase 2), all subjects randomized (Phase 2/3); and subjects 12 to 15 years of age (Phase 3); To demonstrate noninferiority of anti–reference strain immune response after a third dose of BNT162b2 at 30 μg compared to after 2 doses of BNT162b2, in the same individuals; To demonstrate noninferiority of anti-SA immune response after 1 dose (BNT162b2-experienced) or 2 doses (BNT162b2-naïve) of BNT162b2SA compared to anti–reference strain immune response after 2 doses of BNT162b2, in the same individuals.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 5775
    Country: Number of subjects enrolled
    Brazil: 2898
    Country: Number of subjects enrolled
    Germany: 500
    Country: Number of subjects enrolled
    South Africa: 800
    Country: Number of subjects enrolled
    Turkey: 500
    Country: Number of subjects enrolled
    United States: 36461
    Worldwide total number of subjects
    46934
    EEA total number of subjects
    500
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    3019
    Adults (18-64 years)
    34709
    From 65 to 84 years
    9164
    85 years and over
    42

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The study consisted of 2 parts. Overall period was created to support display of the demographic characteristics for all study phases and the complete disposition information for each individual phase is presented, in separate tables, below.

    Pre-assignment
    Screening details
    A total of 46934 subjects were randomised and assigned to the treatment. The study consisted of 2 parts. Phase 1: to identify preferred vaccine candidate and dose level of candidate vaccine; Phase 2/3: an expanded cohort and efficacy part.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b1 20 mcg dose:18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b1 30 mcg dose:18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b1 100 mcg dose:18-85 years of age
    Arm description
    Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: Placebo: 18-55 Years of Age
    Arm description
    Subjects were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    Phase 1: BNT162b2 10 mcg dose: 18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b2 20 mcg dose: 18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b2 30 mcg dose: 18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 2/3: BNT162b2 (30mcg): 12-15 years of age
    Arm description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 2/3: Placebo: 12-15 years of age
    Arm description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Arm description
    Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 2/3: Placebo: >=16 years of age
    Arm description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Arm description
    Subjects randomised to receive 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 SA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 milliliter

    Number of subjects in period 1
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age Phase 1: BNT162b1 20 mcg dose:18-85 years of age Phase 1: BNT162b1 30 mcg dose:18-85 years of age Phase 1: BNT162b1 100 mcg dose:18-85 years of age Phase 1: Placebo: 18-55 Years of Age Phase 1: BNT162b2 10 mcg dose: 18-85 years of age Phase 1: BNT162b2 20 mcg dose: 18-85 years of age Phase 1: BNT162b2 30 mcg dose: 18-85 years of age Phase 2/3: BNT162b2 (30mcg): 12-15 years of age Phase 2/3: Placebo: 12-15 years of age Phase 2/3: BNT162b2 (30 mcg): >=16 years of age Phase 2/3: Placebo: >=16 years of age Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Started
    24
    24
    24
    12
    39
    24
    24
    24
    1134
    1130
    22071
    22071
    333
    Completed
    24
    24
    24
    12
    39
    24
    24
    24
    1134
    1130
    22071
    22071
    333
    Period 2
    Period 2 title
    Phase 1
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1:BNT162b1 100 mcg dose:18-85 years of age (2 doses)
    Arm description
    Subjects aged 18-85 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: Placebo: 18-85 Years of Age
    Arm description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Placebo

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age
    Arm description
    Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
    Arm description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Number of subjects in period 2
    Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses) Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses) Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses) Phase 1:BNT162b1 100 mcg dose:18-85 years of age (2 doses) Phase 1: Placebo: 18-85 Years of Age Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
    Started
    24
    24
    24
    12
    39
    24
    24
    24
    Completed
    14
    18
    13
    8
    23
    20
    19
    16
    Not completed
    10
    6
    11
    4
    16
    4
    5
    8
         Consent withdrawn by subject
    -
    1
    2
    -
    1
    -
    -
    -
         No longer meets eligibility criteria
    5
    -
    5
    1
    7
    3
    1
    4
         Unspecified
    -
    -
    -
    -
    2
    1
    1
    1
         Lost to follow-up
    -
    -
    -
    1
    -
    -
    -
    1
         Protocol deviation
    5
    5
    4
    2
    6
    -
    3
    2
    Period 3
    Period 3 title
    Phase 2/3: Blinded Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Arm description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 2/3: Placebo 12-15 Years
    Arm description
    Subjects aged 12-15 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Arm description
    Subjects aged greater than or equal to 16 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    Phase 2/3: Placebo for >=16 years of age
    Arm description
    Subjects aged greater than or equal to 16 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Number of subjects in period 3
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years Phase 2/3: Placebo 12-15 Years Phase 2/3: BNT162b2 (30 mcg): >=16 years of age Phase 2/3: Placebo for >=16 years of age
    Started
    1134
    1130
    22071
    22071
    Completed
    3
    2
    21
    37
    Not completed
    1131
    1128
    22050
    22034
         Physician decision
    -
    -
    5
    7
         Subjects entered open label period
    1119
    1110
    21500
    21351
         Withdrawal by parent/guardian
    1
    5
    1
    -
         Consent withdrawn by subject
    1
    7
    139
    250
         No longer meets eligibility criteria
    -
    2
    16
    21
         Adverse event, non-fatal
    -
    -
    9
    9
         Death
    -
    -
    18
    16
         Refused further study procedures
    -
    -
    2
    -
         Medication error without associated adverse event
    -
    -
    1
    -
         Pregnancy
    -
    -
    -
    1
         Unspecified
    3
    1
    33
    11
         Randomised but not vaccinated
    3
    1
    55
    48
         Lost to follow-up
    4
    2
    256
    281
         Protocol deviation
    -
    -
    15
    39
    Period 4
    Period 4 title
    Phase 2/3: Open label
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Arm description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 microgram/0.5 milliliter

    Arm title
    Phase2/3: Placebo 12-15 Years
    Arm description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    Phase 2/3: BNT162b2 (30 mcg) >=16 years of age
    Arm description
    Subjects aged >=16 years of age were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 microgram/0.5 milliliter

    Arm title
    Phase 2/3: Placebo
    Arm description
    Subjects aged >=16 years of age were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Number of subjects in period 4
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years Phase2/3: Placebo 12-15 Years Phase 2/3: BNT162b2 (30 mcg) >=16 years of age Phase 2/3: Placebo
    Started
    1119
    1110
    21500
    21351
    Completed
    560
    661
    6954
    10428
    Not completed
    559
    449
    14546
    10923
         Consent withdrawn by subject
    49
    52
    1500
    1792
         Physician decision
    -
    -
    35
    31
         No longer meets eligibility criteria
    107
    114
    940
    1580
         Adverse event, non-fatal
    -
    -
    4
    6
         Death
    -
    1
    67
    68
         Pregnancy
    -
    -
    1
    2
         Refused further study procedure
    -
    -
    7
    12
         Unspecified
    293
    173
    9647
    3608
         Lost to follow-up
    59
    55
    1089
    1402
         Withdrawal by parent/guardian
    14
    19
    2
    -
         Protocol deviation
    37
    35
    1254
    2422
    Period 5
    Period 5 title
    Phase 3: BNT162b2-Naïve Subjects
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Phase 3: BNT162b2 SA 30 mcg >=16 years of age
    Arm description
    Subjects aged >=16 years received 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 SA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 microgram/0.5 milliliter

    Number of subjects in period 5
    Phase 3: BNT162b2 SA 30 mcg >=16 years of age
    Started
    333
    Completed
    228
    Not completed
    105
         Consent withdrawn by subject
    19
         No longer meets eligibility criteria
    8
         Adverse event, non-fatal
    1
         Unspecified
    24
         Lost to follow-up
    50
         Protocol deviation
    3

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 20 mcg dose:18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 30 mcg dose:18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 100 mcg dose:18-85 years of age
    Reporting group description
    Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

    Reporting group title
    Phase 1: Placebo: 18-55 Years of Age
    Reporting group description
    Subjects were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 1: BNT162b2 10 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 20 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 30 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: BNT162b2 (30mcg): 12-15 years of age
    Reporting group description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: 12-15 years of age
    Reporting group description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Reporting group description
    Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: >=16 years of age
    Reporting group description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Reporting group description
    Subjects randomised to receive 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly.

    Reporting group values
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age Phase 1: BNT162b1 20 mcg dose:18-85 years of age Phase 1: BNT162b1 30 mcg dose:18-85 years of age Phase 1: BNT162b1 100 mcg dose:18-85 years of age Phase 1: Placebo: 18-55 Years of Age Phase 1: BNT162b2 10 mcg dose: 18-85 years of age Phase 1: BNT162b2 20 mcg dose: 18-85 years of age Phase 1: BNT162b2 30 mcg dose: 18-85 years of age Phase 2/3: BNT162b2 (30mcg): 12-15 years of age Phase 2/3: Placebo: 12-15 years of age Phase 2/3: BNT162b2 (30 mcg): >=16 years of age Phase 2/3: Placebo: >=16 years of age Phase 3: BNT162b2 SA 30 mcg Single Booster Dose Total
    Number of subjects
    24 24 24 12 39 24 24 24 1134 1130 22071 22071 333 46934
    Age Categorical
    Units: Subjects
        <=18 years
    0 0 0 0 0 0 0 0 1134 1130 378 377 0 3019
        Between 18 and 65 years
    12 12 12 12 21 12 12 12 0 0 17130 17141 333 34709
        >=65 years
    12 12 12 0 18 12 12 12 0 0 4563 4553 0 9206
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    49.5 ± 21.36 57.7 ± 14.76 52.9 ± 18.88 38.3 ± 9.34 51.0 ± 19.18 52.4 ± 18.13 54.3 ± 18.87 52.9 ± 17.46 13.6 ± 1.11 13.6 ± 1.11 49.7 ± 15.99 49.6 ± 16.06 35.7 ± 10.72 -
    Sex: Female, Male
    Units: Subjects
        Female
    13 11 14 7 22 17 13 15 564 544 10724 10952 160 23056
        Male
    11 13 10 5 17 7 11 9 570 586 11347 11119 173 23878
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 0 1 0 1 1 1 0 132 130 5716 5710 42 11735
        Not Hispanic or Latino
    23 24 22 12 38 23 23 24 1000 997 16281 16261 288 35016
        Unknown or Not Reported
    0 0 1 0 0 0 0 0 2 3 74 100 3 183
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0 0 4 3 222 217 0 446
        Asian
    3 0 4 1 1 1 0 2 72 71 951 947 26 2079
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0 0 3 0 53 31 0 87
        Black or African American
    1 2 0 0 0 0 2 1 52 57 2098 2121 40 4374
        White
    20 22 20 11 38 23 22 21 973 963 18090 18103 261 38567
        More than one race
    0 0 0 0 0 0 0 0 24 29 580 540 4 1177
        Unknown or Not Reported
    0 0 0 0 0 0 0 0 6 7 77 112 2 204

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 20 mcg dose:18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 30 mcg dose:18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 100 mcg dose:18-85 years of age
    Reporting group description
    Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

    Reporting group title
    Phase 1: Placebo: 18-55 Years of Age
    Reporting group description
    Subjects were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 1: BNT162b2 10 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 20 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 30 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: BNT162b2 (30mcg): 12-15 years of age
    Reporting group description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: 12-15 years of age
    Reporting group description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Reporting group description
    Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: >=16 years of age
    Reporting group description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Reporting group description
    Subjects randomised to receive 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly.
    Reporting group title
    Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1:BNT162b1 100 mcg dose:18-85 years of age (2 doses)
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Reporting group title
    Phase 1: Placebo: 18-85 Years of Age
    Reporting group description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age
    Reporting group description
    Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
    Reporting group description
    Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Reporting group description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo 12-15 Years
    Reporting group description
    Subjects aged 12-15 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Reporting group description
    Subjects aged greater than or equal to 16 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo for >=16 years of age
    Reporting group description
    Subjects aged greater than or equal to 16 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Reporting group description
    Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase2/3: Placebo 12-15 Years
    Reporting group description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg) >=16 years of age
    Reporting group description
    Subjects aged >=16 years of age were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo
    Reporting group description
    Subjects aged >=16 years of age were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Reporting group title
    Phase 3: BNT162b2 SA 30 mcg >=16 years of age
    Reporting group description
    Subjects aged >=16 years received 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly.

    Subject analysis set title
    BNT162b1 10 mcg dose: 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 20 mcg dose: 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 20 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 30 mcg dose: 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 100 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Subject analysis set title
    Placebo 18-55 Years of Age for BNT162b1 100 mcg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly but received two doses of BNT162b2 (30 mcg) in the open-label vaccination period.

    Subject analysis set title
    BNT162b2 10 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 20 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 30 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): >=16 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    10 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    20 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    30 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo: 18-55 years of age for BNT162b1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo 100 µg Dose, 18-55 Years of Age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    10 mcg dose, 18-55 years of age B2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    20 mcg dose, 18-55 years of age B2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    30 mcg dose, 18-55 years of age B2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b1 10 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 20 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 20 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 30 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo, 65-85 years of age for BNT162b1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 10 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 10 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 20 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 20 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 30 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    30 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 10 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 10 mcg dose, 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-85 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 20 mcg dose, 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-85 years were randomised to receive 20 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 30 mcg dose, 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-85 years were randomised to receive 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    100 mcg dose, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): 65-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 (30 mcg): 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 56-85 were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 18-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo, 18-55 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 16-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:16-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 16-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:16-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo: 18-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo: 18-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): >=16 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    10 mcg dose, 18-55 years of age B2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b1 10 mcg dose, 65-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects of 65 to 85 years of age who originally received placebo were eligible to receive 2 booster doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval.

    Subject analysis set title
    30 mcg dose, 65-85 years of age B2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo: 18-55 years of age for BNT162b1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): Reference Strain
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA 30 mcg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg): SA variant
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): Reference Strain
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA 30 mcg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 μg): Reference Strain
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 μg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): Reference Strain
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 65-85 years of age for BNT162b2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 18-55 years of age for BNT162b2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 10 mcg dose, 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 10 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 20 mcg dose, 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 20 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 30 mcg dose, 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 100 mcg: 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Subject analysis set title
    Placebo/BNT162b2 30 mcg: 18-85 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 12-15 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo: 12-15 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: >=16 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo/BNT162b2 30 mcg: 12-15 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 30 mcg: >=16 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo/BNT162b2 30 mcg: >=16 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo: >=16 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 16-25 years of age
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects aged 16-25 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 1 [1]
    End point description
    Local reactions included redness, swelling and, pain at the injection site, recorded by subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 centimeter [cm]), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalisation for severe pain). Safety population included all randomised subjects who received at least 1 dose of the study intervention. 'Number of Subjects Analysed’ signifies the subject was in the safety population and had e-diary data after Dose 1. HIV positive subjects were excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Within 7 days after dose 1
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    9
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Mild
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    0 (0.0 to 70.8)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.8)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Mild
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    41.7 (15.2 to 72.3)
    33.3 (9.9 to 65.1)
    66.7 (9.4 to 99.2)
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    75.0 (42.8 to 94.5)
    0 (0.0 to 33.6)
    58.3 (27.7 to 84.8)
    83.3 (51.6 to 97.9)
    66.7 (34.9 to 90.1)
    11.1 (0.3 to 48.2)
    33.3 (9.9 to 65.1)
    58.3 (27.7 to 84.8)
    75.0 (42.8 to 94.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Moderate
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    58.3 (27.7 to 84.8)
    58.3 (27.7 to 84.8)
    0 (0.0 to 70.8)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 1 [2]
    End point description
    Local reactions included redness, swelling and, pain at the injection site, recorded by subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 centimeter [cm]), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalisation for severe pain). Safety population included all randomised subjects who received at least 1 dose of the study intervention. 'Number of Subjects Analysed’ signifies the subject was in the safety population and had e-diary data after Dose 2 . HIV positive subjects were excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Within 7 days after dose 2
    Notes
    [2] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Mild
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Mild
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    41.7 (15.2 to 72.3)
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    75.0 (42.8 to 94.5)
    0 (0.0 to 33.6)
    58.3 (27.7 to 84.8)
    83.3 (51.6 to 97.9)
    66.7 (34.9 to 90.1)
    11.1 (0.3 to 48.2)
    33.3 (9.9 to 65.1)
    58.3 (27.7 to 84.8)
    75.0 (42.8 to 94.5)
    11.1 (0.3 to 48.2)
    22.2 (2.8 to 60.0)
        Pain at injection site: Moderate
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    58.3 (27.7 to 84.8)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 1 [3]
    End point description
    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by subjects using e-diary. Fever=temperature >=38.0 degrees C categorised as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalisation). Vomiting: mild (1-2 times in 24 hours[h]), moderate (more than 2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2 to 3 loose stools in 24h), moderate (4 to 5 loose stools in 24 h), severe (6 or more loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Safety population assessed.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 2
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0°C to 38.4°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.4°C to 38.9°C
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.9°C to 40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Mild
    25.0 (5.5 to 57.2)
    41.7 (15.2 to 72.3)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    33.3 (0.8 to 90.6)
    25.0 (5.5 to 57.2)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    16.7 (2.1 to 48.4)
    33.3 (7.5 to 70.1)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    22.2 (2.8 to 60.0)
        Fatigue: Moderate
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    50.0 (21.1 to 78.9)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    25.0 (5.5 to 57.2)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    22.2 (2.8 to 60.0)
    11.1 (0.3 to 48.2)
        Fatigue: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.3 to 48.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Headache: Mild
    33.3 (9.9 to 65.1)
    41.7 (15.2 to 72.3)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    66.7 (9.4 to 99.2)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    22.2 (2.8 to 60.0)
        Headache: Moderate
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    11.1 (0.3 to 48.2)
        Headache: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.)
        Headache: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Mild
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    22.2 (2.8 to 60.0)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Moderate
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.6)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Mild
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        Diarrhea: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Mild
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    25.0 (5.5 to 57.2)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 48.2)
    0 (0.0 to 33.6)
        New or worsened joint pain: Mild
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened joint pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 1 [4]
    End point description
    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by subjects using e-diary. Fever=temperature >=38.0 degrees C categorised as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalisation). Vomiting: mild (1-2 times in 24 hours[h]), moderate (more than 2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2 to 3 loose stools in 24h), moderate (4 to 5 loose stools in 24 h), severe (6 or more loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Safety population assessed.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 2
    Notes
    [4] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0°C to 38.4°C
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.4°C to 38.9°C
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    58.3 (27.7 to 84.8)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.9°C to 40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Mild
    25.0 (5.5 to 57.2)
    50.0 (21.1 to 78.9)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    33.3 (0.8 to 90.6)
    25.0 (5.5 to 57.2)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    11.1 (0.3 to 48.2)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    22.2 (0.0 to 33.6)
        Fatigue: Moderate
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    66.7 (34.9 to 90.1)
    50.0 (21.1 to 78.9)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    8.3 (0.2 to 38.5)
    41.7 (15.2 to 72.3)
    33.3 (9.9 to 65.1)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    11.1 (0.3 to 48.2)
        Fatigue: Severe
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Headache: Mild
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    58.3 (27.7 to 84.8)
    41.7 (15.2 to 72.3)
    66.7 (9.4 to 99.2)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    33.3 (9.9 to 65.1)
    33.3 (9.9 to 65.1)
    50.0 (2.1 to 78.9)
    11.1 (0.3 to 48.2)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    22.2 (2.8 to 60.0)
        Headache: Moderate
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    25.0 (5.5 to 57.2)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    11.1 (0.3 to 48.2)
        Headache: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Headache: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Mild
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Moderate
    25.0 (5.5 to 57.2)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Mild
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        Diarrhea: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Mild
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    25.0 (5.5 to 57.2)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Moderate
    8.3 (0.2 to 38.5)
    58.3 (27.7 to 84.8)
    41.7 (15.2 to 72.3)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Mild
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Moderate
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened joint pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1 [5]
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. For BNT162b1 100 mcg, subjects received one dose of 100 mcg, followed by one dose of 10 mcg. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 to 1 Month After Dose 2
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age BNT162b1 10 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    9
    12
    12
    12
    9
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    50.0
    41.7
    50.0
    66.7
    33.3
    33.3
    41.7
    41.7
    22.2
    58.3
    25.0
    44.4
    8.3
    8.3
    25.0
    50.0
    22.2
    22.2
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1 [6]
    End point description
    An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. For BNT162b1 100 mcg, subjects received one dose of 100 mcg, followed by one dose of 10 mcg. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 to 6 Months After Dose 2
    Notes
    [6] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose, 18-85 years of age BNT162b1 20 mcg dose, 18-85 years of age BNT162b1 30 mcg dose, 18-85 years of age BNT162b2 10 mcg dose, 18-85 years of age BNT162b2 20 mcg dose, 18-85 years of age BNT162b2 30 mcg dose, 18-85 years of age BNT162b1 100 mcg: 18-85 years of age Placebo/BNT162b2 30 mcg: 18-85 years of age
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    12
    35
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 14.2)
    0 (0.0 to 14.2)
    0 (0.0 to 14.2)
    0 (0.0 to 14.2)
    4.2 (0.1 to 21.1)
    4.2 (0.1 to 21.1)
    0 (0.0 to 26.5)
    0 (0.0 to 10.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1 [7]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day after Dose 1
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Lymphocytes
    8.3
    33.3
    54.5
    75.0
    75.0
    0
    8.3
    8.3
    0
    8.3
    25.0
    16.7
    0
    8.3
    8.3
    8.3
    0
    0
        Neutrophils
    8.3
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    0
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1 [8]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Dose 1
    Notes
    [8] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Lymphocytes
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    11.1
    0
        Neutrophils
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    8.3
    0
    0
    0
    0
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters Before Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Hematology Parameters Before Dose 2: Phase 1 [9]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophils
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
        Lymphocytes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    8.3
    0
    8.3
    0
    0
        Eosinophils
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1 [10]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 days after Dose 2
    Notes
    [10] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    9
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Neutrophils
    8.3
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    8.3
    0
    0
    0
    0
        Monocytes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    11.1
        Eosinophils
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    0
    0
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1 [11]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day after Dose 1
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1 [12]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 days after dose 1
    Notes
    [12] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1 [13]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1 [14]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days after Dose 2
    Notes
    [14] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1 [15]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day After Dose 1
    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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    75.0
    0
    0
    0
    0
    0
    0
    83.3
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
        Hemoglobin: Normal to Grade 1
    8.3
    0
    0
    0
    0
    0
    0
    16.7
    0
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    0
        Hemoglobin: Grade 1 to Normal
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    66.7
    25.0
    18.2
    0
    0
    75.0
    75.0
    0
    0
    33.3
    16.7
    41.7
    0
    75.0
    33.3
    66.7
    88.9
    0
        Lymphocytes: Normal to Grade1
    16.7
    41.7
    27.3
    16.7
    0
    25.0
    16.7
    0
    0
    50.0
    16.7
    33.3
    0
    16.7
    50.0
    25.0
    11.1
    0
        Lymphocytes: Normal to Grade2
    8.3
    16.7
    45.5
    50.0
    0
    0
    8.3
    0
    0
    8.3
    66.7
    16.7
    0
    0
    16.7
    0
    0
    0
        Lymphocytes: Normal to Grade3
    8.3
    16.7
    9.1
    33.3
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    0
    8.3
    0
    0
    0
    0
        Neutrophil Decrease: Baseline Normal to Normal
    83.3
    0
    0
    0
    0
    91.7
    91.7
    91.7
    0
    91.7
    91.7
    91.7
    88.9
    83.3
    66.7
    0
    88.9
    87.5
        Neutrophil Decrease: Grade1 to Normal
    8.3
    0
    0
    0
    0
    8.3
    8.3
    8.3
    88.9
    8.3
    8.3
    8.3
    11.1
    16.7
    8.3
    0
    11.1
    12.5
        Platelets Decrease: Normal to Grade1
    0
    91.7
    0
    0
    0
    0
    0
    0
    12.5
    0
    8.3
    8.3
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Baseline Normal to Normal
    91.7
    8.3
    0
    0
    0
    0
    0
    0
    88.9
    91.7
    0
    0
    88.9
    91.7
    0
    0
    0
    0
        Urea Nitrogen: Grade1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    0
        WBC Decrease: Baseline Normal to Normal
    91.7
    91.7
    0
    0
    0
    91.7
    0
    0
    0
    83.3
    75.0
    0
    88.9
    0
    75.0
    91.7
    0
    0
        WBC Decrease: Grade1 to Normal
    8.3
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    16.7
    25.0
    0
    11.1
    83.3
    8.3
    0
    0
    0
        WBC Decrease: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    16.7
    8.3
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1 [16]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days After Dose 1
    Notes
    [16] - 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: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    83.3
    75.0
    0
    91.7
    0
    91.7
    0
    0
    0
    91.7
    83.3
    0
    0
    91.7
    91.7
    91.7
    88.9
    88.9
        Hemoglobin: Grade1 to Normal
    16.7
    8.3
    0
    8.3
    0
    8.3
    0
    0
    0
    8.3
    8.3
    0
    0
    0
    0
    0
    11.1
    11.1
        Hemoglobin: Normal to Grade1
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hemoglobin: Grade1 to Grade1
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    8.3
    0
    0
        Hemoglobin: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    91.7
    0
    0
    0
    0
    0
    0
    91.7
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    88.9
    77.8
        Lymphocytes: Normal to Grade1
    8.3
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    8.3
    0
    11.1
    11.1
        Lymphocytes: Grade1 to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
        Neutrophil decrease: Baseline Normal to Normal
    83.3
    91.7
    91.7
    75.0
    0
    83.3
    0
    0
    0
    0
    0
    0
    0
    83.3
    91.7
    0
    88.9
    88.9
        Neutrophil decrease: Normal to Grade1
    8.3
    8.3
    8.3
    25.0
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    0
    11.1
    11.1
        Neutrophil decrease: Grade1 to Grade1
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
        Neutrophil decrease: Normal to Grade2
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Platelets Decrease: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    90.9
    0
    90.9
    0
    0
    77.8
    0
        Platelets Decrease: Normal to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    9.1
    0
    9.1
    0
    0
    11.1
    0
        Platelets Decrease: Grade1 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
        Urea Nitrogen: Baseline Normal to Normal
    0
    91.7
    91.7
    0
    0
    91.7
    0
    0
    88.9
    91.7
    91.7
    91.7
    88.9
    0
    91.7
    83.3
    88.9
    0
        Urea Nitrogen: Grade1 to Normal
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    8.3
    8.3
    0
    8.3
    0
    11.1
    0
        Urea Nitrogen: Normal to Grade1
    0
    0
    8.3
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Normal to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    16.7
    0
    0
        WBC decrease: Baseline Normal to Normal
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    83.3
    0
    0
    83.3
    0
    91.7
    88.9
    0
        WBC decrease: Normal to Grade1
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    8.3
    0
    8.3
    11.1
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters Before Dose 2: Phase 1

    Close Top of page
    End point title
    Percentage of Subjects With Grade Shift in Hematology Parameters Before Dose 2: Phase 1 [17]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    50.0
    75.0
    0
    0
    0
    0
    0
    83.3
    0
    91.7
    83.3
    0
    0
    91.7
    91.7
    83.3
    0
    88.9
        Hemoglobin: Normal to Grade1
    33.3
    8.3
    0
    0
    0
    0
    0
    16.7
    0
    0
    8.3
    0
    0
    0
    0
    8.3
    0
    11.1
        Hemoglobin: Grade1 to Normal
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
        Hemoglobin: Grade1 to Grade1
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    8.3
    8.3
    0
    0
    0
        Hemoglobin: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    91.7
    83.3
    0
    0
    0
    0
    0
    0
    88.9
    0
    83.3
    0
    0
    91.7
    0
    91.7
    88.9
    0
        Lymphocytes: Normal to Grade1
    8.3
    16.7
    0
    0
    0
    0
    0
    0
    11.1
    0
    16.7
    0
    0
    8.3
    0
    0
    0
    0
        Lymphocytes: Grade1 to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    11.1
    11.1
        Neutrophil Decrease: Baseline Normal to Normal
    91.7
    0
    0
    0
    0
    83.3
    0
    0
    77.8
    83.3
    83.3
    91.7
    0
    91.7
    83.3
    0
    0
    77.8
        Neutrophil Decrease: Normal to Grade1
    0
    0
    0
    0
    0
    8.3
    0
    0
    22.2
    8.3
    8.3
    0
    0
    8.3
    8.3
    0
    0
    11.1
        Neutrophil Decrease: Normal to Grade2
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophil Decrease: Grade1 to Grade1
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophil Decrease: Grade1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    8.3