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    Clinical Trial Results:
    A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19 using different dosing regimens in healthy and immunocompromised adults

    Summary
    EudraCT number
    2020-001038-36
    Trial protocol
    DE  
    Global end of trial date
    13 Apr 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Apr 2023
    First version publication date
    27 Apr 2023
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    BNT162-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04380701
    WHO universal trial number (UTN)
    U1111-1249-4220
    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, 0049 613190840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, 0049 613190840, patients@biontech.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after single dose (SD; prime only) or prime/boost (P/B) immunization.
    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 trial participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 512
    Worldwide total number of subjects
    512
    EEA total number of subjects
    512
    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)
    0
    Adults (18-64 years)
    434
    From 65 to 84 years
    78
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Study participants were selected from the volunteer panel at the clinical CRO, volunteers who responded to either generic or study-specific advertisements in social media, or volunteers who contacted the clinical CRO via a web-based study participant recruitment portal.

    Pre-assignment
    Screening details
    Study participants were selected from this pool of volunteers according to inclusion and exclusion criteria. The first participant was enrolled on 23 APR 2020. All enrolled participants were allocated to treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Arm description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162a1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Arm description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162a1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Arm description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162a1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg
    Arm description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), Immunocompromised participants (ICP) expansion cohort (Cohort 13).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), ICP expansion cohort (Cohort 13). PT = post-transplant.
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), adaptive immune response dose group expansion cohort (C12 = Cohort 12).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Arm description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Arm description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162c2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Number of subjects in period 1
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Started
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    15
    15
    30
    90
    20
    12
    12
    12
    12
    12
    12
    12
    12
    Completed end of treatment phase
    12
    12
    6
    12
    12
    11
    10
    11
    11
    12
    12
    12
    12
    11
    12
    11
    12
    12
    12
    12
    12
    15
    15
    30
    89
    19
    12
    12
    12
    11
    12
    12
    11
    12
    Completed
    12
    12
    6
    12
    12
    11
    10
    11
    11
    11
    12
    11
    12
    11
    12
    11
    11
    12
    12
    11
    11
    0
    0
    0
    0
    19
    12
    12
    12
    10
    12
    12
    11
    11
    Not completed
    0
    0
    0
    0
    0
    1
    2
    1
    1
    1
    0
    1
    0
    1
    0
    1
    1
    0
    0
    1
    1
    15
    15
    30
    90
    1
    0
    0
    0
    2
    0
    0
    1
    1
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
    -
    1
    -
    1
    -
    -
    1
    -
    -
    -
    -
    -
    2
    2
    1
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Roll-over into trial BNT162-14
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    11
    11
    10
    31
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Non-trial SARS-COV-2 vaccination due to COVID-19
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    4
    2
    16
    55
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Pregnancy
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
         Private reason(s)
    -
    -
    -
    -
    -
    -
    1
    -
    1
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    1
    -
    -
    -
    -
    -
    1
    -
    -
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), Immunocompromised participants (ICP) expansion cohort (Cohort 13).

    Reporting group title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), ICP expansion cohort (Cohort 13). PT = post-transplant.

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), adaptive immune response dose group expansion cohort (C12 = Cohort 12).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD Total
    Number of subjects
    12 12 6 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 15 15 30 90 20 12 12 12 12 12 12 12 12 512
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.80 ± 2.58 48.31 ± 9.04 38.22 ± 13.87 38.21 ± 10.48 41.44 ± 11.27 43.62 ± 11.03 39.42 ± 11.41 35.74 ± 8.60 33.88 ± 10.72 35.81 ± 12.50 64.31 ± 5.89 65.66 ± 5.95 67.16 ± 6.47 36.65 ± 10.14 39.64 ± 10.14 35.07 ± 10.46 42.75 ± 9.89 47.21 ± 6.43 65.44 ± 7.42 65.88 ± 6.56 63.87 ± 5.42 48.04 ± 10.36 48.93 ± 11.87 51.92 ± 13.57 55.59 ± 16.07 48.45 ± 13.87 36.42 ± 10.33 39.41 ± 12.34 34.47 ± 10.24 35.42 ± 9.68 40.03 ± 14.67 35.23 ± 11.88 42.40 ± 12.04 32.60 ± 10.87 -
    Gender categorical
    Units: Subjects
        Female
    5 6 1 7 6 8 4 4 6 5 5 10 8 5 7 8 10 4 4 6 8 3 9 13 45 10 8 5 3 8 10 8 5 7 261
        Male
    7 6 5 5 6 4 8 8 6 7 7 2 4 7 5 4 2 8 8 6 4 12 6 17 45 10 4 7 9 4 2 4 7 5 251
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 2 0 0 1 0 0 6
        Not Hispanic or Latino
    12 12 6 11 12 12 12 12 12 11 12 12 12 12 12 12 12 12 12 12 12 15 15 30 89 20 12 12 10 12 12 11 12 12 506
    Race
    Units: Subjects
        Asian
    0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 0 0 0 0 1 0 0 6
        Black or African American
    0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 2
        White
    12 12 5 12 12 11 11 12 12 11 12 12 12 12 12 12 12 12 12 12 12 14 15 30 89 19 11 11 12 12 12 11 12 12 502
        More than one race
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1
        Unknown or Not Reported
    0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    77.68 ± 7.59 72.54 ± 10.85 78.58 ± 14.93 72.99 ± 14.79 77.11 ± 14.07 71.57 ± 14.09 73.58 ± 11.88 79.84 ± 13.81 76.73 ± 13.32 78.70 ± 13.85 71.90 ± 10.98 70.38 ± 9.14 69.98 ± 8.06 80.18 ± 14.13 77.08 ± 10.84 76.11 ± 11.67 72.45 ± 10.97 77.78 ± 8.43 77.87 ± 9.78 76.91 ± 12.38 75.80 ± 11.98 73.85 ± 9.67 73.50 ± 10.07 77.79 ± 12.92 75.44 ± 13.02 79.09 ± 14.94 67.45 ± 13.53 76.41 ± 15.66 72.44 ± 6.86 70.94 ± 11.43 63.75 ± 6.14 73.26 ± 15.39 73.48 ± 9.51 68.90 ± 11.56 -
    Body mass index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    24.61 ± 3.14 24.23 ± 2.78 24.73 ± 2.63 25.17 ± 2.89 24.94 ± 2.68 24.20 ± 2.32 24.34 ± 2.33 25.68 ± 3.44 25.52 ± 3.50 25.19 ± 3.09 24.73 ± 2.46 25.59 ± 2.22 25.63 ± 2.22 25.25 ± 3.26 25.50 ± 2.79 25.13 ± 2.07 25.43 ± 2.34 25.01 ± 1.38 25.43 ± 2.15 25.62 ± 2.47 25.85 ± 2.75 23.62 ± 1.90 25.63 ± 2.82 25.53 ± 2.72 25.08 ± 2.73 26.12 ± 2.96 23.31 ± 2.38 25.02 ± 2.85 23.83 ± 2.39 25.06 ± 3.73 22.82 ± 1.54 24.97 ± 3.17 24.19 ± 2.04 24.04 ± 2.59 -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), Immunocompromised participants (ICP) expansion cohort (Cohort 13).

    Reporting group title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), ICP expansion cohort (Cohort 13). PT = post-transplant.

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), adaptive immune response dose group expansion cohort (C12 = Cohort 12).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Primary: Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose

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    End point title
    Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose [1]
    End point description
    Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Safety Set - all participants who received at least one dose of the IMP. 'Prime to D7' below indicates Prime up to Day 7 after Prime, 'Boost to D7' below indicates Boost up to Day 7 after Boost. 999 indicates data not available as the boost immunization was withheld for the BNT162a1 3 μg cohort and the BNT162b1 60 μg younger cohort following Safety Review Committee (SRC) decision. 9999 indicates data not available as the boost immunization was not administered to the BNT162c2 SD regimen cohorts.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
    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 was planned for this endpoint.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    15
    15
    30
    90
    20
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        Prime to D7: any local reaction
    9
    11
    6
    6
    5
    10
    12
    11
    12
    12
    7
    11
    11
    6
    9
    12
    12
    10
    7
    9
    9
    12
    14
    16
    82
    20
    4
    3
    8
    11
    4
    7
    5
    11
        Prime to D7: any severe/grade ≥3 local reaction
    0
    0
    0
    0
    0
    1
    2
    4
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Boost to D7: any local reaction
    3
    10
    999
    7
    5
    10
    11
    11
    11
    999
    8
    9
    9
    4
    8
    10
    10
    11
    7
    8
    10
    12
    11
    27
    79
    19
    3
    5
    7
    8
    9999
    9999
    9999
    9999
        Boost to D7: any severe/grade ≥3 local reaction
    0
    0
    999
    2
    0
    0
    0
    2
    3
    999
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    2
    1
    0
    0
    0
    0
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose

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    End point title
    Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose [2]
    End point description
    Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Safety Set - all participants who received at least one dose of the IMP. Prime to D7 below indicates Prime up to Day 7 after Prime, Boost to D7 below indicates Boost up to Day 7 after Boost. 999 indicates data not available as the boost immunization was withheld for the BNT162a1 3 μg cohort and the BNT162b1 60 μg younger cohort following SRC decision. 9999 indicates data not available as the boost immunization was not administered to the BNT162c2 SD regimen cohorts.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
    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 was planned for this endpoint.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    15
    15
    30
    90
    20
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        Prime to D7: any local reaction
    6
    12
    6
    9
    8
    8
    11
    11
    12
    12
    9
    10
    11
    9
    9
    12
    9
    9
    3
    4
    9
    12
    14
    12
    68
    15
    5
    8
    9
    12
    7
    7
    4
    8
        Prime to D7: any severe/grade ≥3 local reaction
    1
    1
    5
    0
    0
    1
    2
    3
    5
    8
    1
    1
    2
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    5
    0
    0
    0
    1
    1
    0
    2
    0
    2
        Boost to D7: any local reaction
    3
    12
    999
    7
    7
    9
    10
    11
    11
    999
    8
    10
    12
    4
    2
    7
    10
    10
    4
    8
    11
    13
    12
    21
    78
    16
    3
    7
    6
    9
    9999
    9999
    9999
    9999
        Boost to D7: any severe/grade ≥3 local reaction
    0
    4
    999
    3
    1
    5
    5
    6
    5
    999
    2
    2
    4
    0
    0
    1
    1
    3
    1
    0
    2
    4
    1
    4
    14
    3
    1
    1
    0
    2
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Primary: The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1

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    End point title
    The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1 [3]
    End point description
    TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade ≥3 TEAE) using the Safety Set. Safety Set - all participants who received at least one dose of the IMP.
    End point type
    Primary
    End point timeframe
    28 days following Dose 1 or up to Dose 2 (whichever was first)
    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 was planned for this endpoint.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    15
    15
    30
    90
    20
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Percentage of participants
    number (not applicable)
        Any TEAE
    8
    33
    83
    8
    0
    50
    33
    42
    42
    58
    25
    17
    58
    25
    50
    50
    8
    42
    25
    33
    25
    7
    53
    13
    26
    35
    17
    33
    17
    17
    50
    58
    25
    25
        Any grade ≥3 TEAE
    0
    0
    0
    0
    0
    0
    8
    0
    0
    0
    8
    8
    8
    0
    0
    8
    0
    0
    0
    0
    17
    0
    7
    0
    2
    5
    0
    0
    0
    8
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)

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    End point title
    The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) [4] [5]
    End point description
    TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade ≥3 TEAE) using the Safety Set. Safety Set - all participants who received at least one dose of the IMP.
    End point type
    Primary
    End point timeframe
    28 days following Dose 2 or Dose 1 (if no Dose 2 was given)
    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 was planned for this endpoint.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for the BNT162c2 Single Dose Cohorts are not reported for this endpoint as no Boost dose was planned.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    15
    15
    30
    90
    20
    12
    12
    12
    12
    Units: Percentage of participants
    number (not applicable)
        Any TEAE
    17
    33
    83
    58
    8
    75
    50
    58
    67
    58
    25
    33
    75
    58
    58
    67
    25
    50
    33
    58
    33
    13
    73
    40
    49
    45
    33
    42
    33
    17
        Any grade ≥3 TEAE
    0
    0
    0
    0
    0
    0
    25
    0
    0
    0
    8
    8
    17
    0
    0
    8
    0
    8
    8
    8
    17
    0
    7
    3
    4
    10
    0
    8
    0
    8
    No statistical analyses for this end point

    Secondary: Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

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    End point title
    Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) [6]
    End point description
    At Day 1 (Baseline) and at 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 and/or Day 50 were scheduled before approval of protocol version 7 which implemented these visits. 999 indicates confidence interval not calculated as values of at least 3 participants were not available.
    End point type
    Secondary
    End point timeframe
    Up to 183 days following Dose 1
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162a1, BNT162b1, BNT162b2 Dose Ranging, and BNT162c2 Prime/Boost Cohorts.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        Pre-Prime Immunization (Day 1)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.1 (4.8 to 5.5)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    6.9 (3.4 to 13.8)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
        7 days after Prime Immunization (Day 8)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.1 (4.8 to 5.5)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    8.2 (2.8 to 24.1)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
        21 days after Prime Immunization (Day 22)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    10.0 (6.1 to 16.3)
    6.9 (4.4 to 10.7)
    10.0 (5.4 to 18.5)
    11.7 (6.2 to 22.1)
    29.1 (13.5 to 63.0)
    20.6 (11.5 to 37.0)
    13.7 (7.5 to 25.3)
    16.3 (7.7 to 34.5)
    15.4 (7.8 to 30.4)
    16.3 (8.3 to 32.3)
    5.3 (4.7 to 6.0)
    7.5 (5.6 to 10.1)
    16.6 (9.7 to 28.3)
    16.3 (8.0 to 33.5)
    15.9 (9.6 to 26.2)
    8.4 (5.6 to 12.6)
    7.9 (5.2 to 12.1)
    49.0 (18.3 to 131.4)
    5.0 (5.0 to 5.0)
    5.3 (4.7 to 6.0)
    5.3 (4.7 to 6.0)
    7.1 (4.9 to 10.2)
        7 days after Boost Immunization (Day 29)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    55.0 (32.5 to 93.1)
    9999 (9999 to 9999)
    181.5 (107.5 to 306.3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    320.0 (183.6 to 557.7)
    169.5 (70.3 to 408.7)
    207.5 (94.0 to 458.0)
    38.9 (16.1 to 93.5)
    134.5 (82.2 to 220.1)
    40.0 (-999 to 999)
    213.6 (114.7 to 397.7)
    329.4 (203.2 to 533.9)
    127.0 (79.2 to 203.7)
    164.7 (77.0 to 352.0)
    678.1 (395.9 to 1161.2)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.3 (4.7 to 6.0)
    8.0 (4.8 to 13.4)
        21 days after Boost Immunization (Day 43)
    5.0 (5.0 to 5.0)
    8.7 (3.8 to 19.8)
    5.3 (4.6 to 6.1)
    69.2 (33.0 to 145.4)
    95.1 (47.0 to 192.7)
    62.2 (30.4 to 127.0)
    160.0 (90.3 to 283.6)
    184.9 (96.8 to 353.0)
    282.1 (136.8 to 581.6)
    8.9 (6.1 to 13.0)
    293.4 (179.9 to 478.5)
    95.1 (42.3 to 214.0)
    134.5 (66.8 to 270.8)
    49.9 (26.9 to 92.6)
    109.9 (71.1 to 169.8)
    187.3 (119.9 to 292.6)
    164.7 (89.3 to 303.6)
    300.5 (182.7 to 494.1)
    134.5 (85.4 to 214.1)
    169.5 (115.3 to 249.2)
    452.5 (255.6 to 801.1)
    5.1 (4.8 to 5.5)
    5.6 (4.9 to 6.5)
    5.7 (4.8 to 6.6)
    6.0 (4.6 to 8.0)
        28 days after Boost Immunization (Day 50)
    5.0 (-999 to 999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    80.0 (36.1 to 177.5)
    9999 (9999 to 9999)
    82.3 (37.4 to 181.1)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    226.3 (120.5 to 424.8)
    89.8 (37.5 to 214.9)
    95.1 (50.9 to 178.0)
    36.4 (20.8 to 63.8)
    67.3 (35.7 to 126.7)
    190.3 (118.4 to 305.7)
    160.0 (84.6 to 302.5)
    213.6 (148.8 to 306.6)
    127.0 (75.7 to 213.0)
    132.4 (91.8 to 191.0)
    391.7 (229.4 to 668.8)
    5.0 (5.0 to 5.0)
    5.9 (5.0 to 7.1)
    5.0 (5.0 to 5.0)
    5.3 (4.7 to 6.0)
        63 days after Boost Immunization (Day 85)
    5.0 (5.0 to 5.0)
    7.5 (3.9 to 14.5)
    5.0 (5.0 to 5.0)
    25.9 (14.6 to 46.0)
    31.7 (14.5 to 69.4)
    40.0 (21.1 to 76.0)
    134.5 (70.0 to 258.6)
    102.9 (58.1 to 182.2)
    120.5 (56.1 to 258.7)
    7.7 (5.2 to 11.4)
    46.2 (25.4 to 84.0)
    33.6 (16.6 to 68.1)
    69.2 (33.8 to 142.0)
    36.4 (19.3 to 68.6)
    33.6 (19.9 to 57.0)
    145.6 (85.5 to 247.8)
    146.7 (80.9 to 265.9)
    160.0 (97.4 to 263.0)
    21.8 (12.1 to 39.2)
    27.4 (17.5 to 42.9)
    80.0 (39.1 to 163.5)
    5.6 (5.0 to 6.3)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.2 (4.7 to 5.8)
        162 days after Boost Immunization (Day 184)
    5.0 (5.0 to 5.0)
    6.9 (3.4 to 13.8)
    5.0 (5.0 to 5.0)
    10.0 (6.1 to 16.4)
    15.0 (9.0 to 24.8)
    13.7 (8.8 to 21.4)
    27.4 (14.0 to 53.6)
    29.2 (13.9 to 61.2)
    56.6 (22.3 to 143.6)
    5.2 (4.8 to 5.5)
    16.8 (10.0 to 28.2)
    19.4 (10.7 to 35.1)
    65.4 (31.7 to 134.8)
    8.5 (5.6 to 13.0)
    11.2 (7.8 to 16.2)
    21.3 (12.2 to 37.3)
    54.8 (31.5 to 95.5)
    38.9 (20.6 to 73.2)
    26.7 (14.1 to 50.4)
    15.5 (11.8 to 20.5)
    58.4 (30.6 to 111.3)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.8 (4.2 to 7.9)
    10.4 (3.4 to 31.5)
    No statistical analyses for this end point

    Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

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    End point title
    Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) [7]
    End point description
    At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 and/or Day 50 were scheduled before approval of protocol version 7 which implemented these visits. 999 indicates confidence interval not calculated as values of at least 3 participants were not available.
    End point type
    Secondary
    End point timeframe
    Up to 183 days following Dose 1
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162a1, BNT162b1, BNT162b2 Dose Ranging, and BNT162c2 Prime/Boost Cohorts.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        7 days after Prime Immunization (Day 8)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.2 (0.8 to 1.7)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        21 days after Prime Immunization (Day 22)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    2.0 (1.2 to 3.3)
    1.4 (0.9 to 2.1)
    2.0 (1.1 to 3.7)
    2.3 (1.2 to 4.4)
    5.8 (2.7 to 12.6)
    4.0 (2.2 to 7.3)
    2.7 (1.5 to 5.1)
    3.3 (1.5 to 6.9)
    3.1 (1.6 to 6.1)
    3.3 (1.7 to 6.5)
    1.1 (0.9 to 1.2)
    1.5 (1.1 to 2.0)
    3.3 (1.9 to 5.7)
    3.3 (1.6 to 6.7)
    3.2 (1.9 to 5.2)
    1.7 (1.1 to 2.5)
    1.6 (1.0 to 2.4)
    7.1 (4.3 to 11.9)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.2)
    1.1 (0.9 to 1.2)
    1.4 (1.0 to 2.0)
        7 days after Boost Immunization (Day 29)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    11.0 (6.5 to 18.6)
    9999 (9999 to 9999)
    36.3 (21.5 to 61.3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    64.0 (36.7 to 111.5)
    33.9 (14.1 to 81.7)
    41.5 (18.8 to 91.6)
    7.8 (3.2 to 18.7)
    26.9 (16.4 to 44.0)
    8.0 (-999 to 999)
    42.7 (22.9 to 79.5)
    65.9 (40.6 to 106.8)
    25.4 (15.8 to 40.7)
    32.9 (15.4 to 70.4)
    98.7 (62.2 to 156.5)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.2)
    1.6 (1.0 to 2.7)
        21 days after Boost Immunization (Day 43)
    1.0 (1.0 to 1.0)
    1.7 (0.8 to 4.0)
    1.1 (0.9 to 1.2)
    13.8 (6.6 to 29.1)
    19.0 (9.4 to 38.5)
    12.4 (6.1 to 25.4)
    32.0 (18.1 to 56.7)
    37.0 (19.4 to 70.6)
    54.7 (26.5 to 112.8)
    1.8 (1.2 to 2.6)
    58.7 (36.0 to 95.7)
    19.0 (8.5 to 42.8)
    26.9 (13.4 to 54.2)
    10.0 (5.4 to 18.5)
    22.0 (14.2 to 34.0)
    37.5 (24.0 to 58.5)
    32.9 (17.9 to 60.7)
    60.1 (36.5 to 98.8)
    26.9 (16.9 to 42.8)
    33.9 (23.1 to 49.8)
    65.9 (45.5 to 95.3)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.3)
    1.1 (1.0 to 1.3)
    1.2 (0.9 to 1.6)
        28 days after Boost Immunization (Day 50)
    1.0 (-999 to 999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    16.0 (7.2 to 35.5)
    9999 (9999 to 9999)
    16.5 (7.5 to 36.2)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    45.3 (24.1 to 85.0)
    18.0 (7.5 to 43.0)
    19.0 (10.2 to 35.6)
    7.3 (4.2 to 12.8)
    13.5 (7.1 to 25.3)
    38.1 (23.7 to 61.1)
    32.0 (16.9 to 60.5)
    42.7 (29.8 to 61.3)
    25.4 (15.1 to 42.6)
    26.5 (18.4 to 38.2)
    57.0 (38.6 to 84.3)
    1.0 (1.0 to 1.0)
    1.2 (1.0 to 1.4)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.2)
        63 days after Boost Immunization (Day 85)
    1.0 (1.0 to 1.0)
    1.5 (0.8 to 2.9)
    1.0 (1.0 to 1.0)
    5.2 (2.9 to 9.2)
    6.3 (2.9 to 13.9)
    8.0 (4.2 to 15.2)
    26.9 (14.0 to 51.7)
    20.6 (11.6 to 36.4)
    23.4 (10.8 to 50.4)
    1.5 (1.0 to 2.3)
    9.2 (5.1 to 16.8)
    6.7 (3.3 to 13.6)
    13.8 (6.8 to 28.4)
    7.3 (3.9 to 13.7)
    6.7 (4.0 to 11.4)
    29.1 (17.1 to 49.6)
    29.3 (16.2 to 53.2)
    32.0 (19.5 to 52.6)
    4.4 (2.4 to 7.8)
    5.5 (3.5 to 8.6)
    11.6 (7.3 to 18.7)
    1.1 (1.0 to 1.3)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (0.9 to 1.2)
        162 days after Boost Immunization (Day 184)
    1.0 (1.0 to 1.0)
    1.4 (0.7 to 2.8)
    1.0 (1.0 to 1.0)
    2.0 (1.2 to 3.3)
    3.0 (1.8 to 5.0)
    2.7 (1.8 to 4.3)
    5.5 (2.8 to 10.7)
    5.8 (2.8 to 12.2)
    11.0 (4.3 to 28.2)
    1.0 (1.0 to 1.1)
    3.4 (2.0 to 5.6)
    3.9 (2.1 to 7.0)
    13.1 (6.3 to 27.0)
    1.7 (1.1 to 2.6)
    2.2 (1.6 to 3.2)
    4.3 (2.4 to 7.5)
    11.0 (6.3 to 19.1)
    7.8 (4.1 to 14.6)
    5.3 (2.8 to 10.1)
    3.1 (2.4 to 4.1)
    11.7 (6.1 to 22.3)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.2 (0.8 to 1.6)
    2.1 (0.7 to 6.3)
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

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    End point title
    Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) [8]
    End point description
    At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 and/or Day 50 were scheduled before approval of protocol version 7 which implemented these visits. 999 indicates confidence interval not calculated as values of at least 3 participants were not available.
    End point type
    Secondary
    End point timeframe
    Up to 183 days following Dose 1
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162a1, BNT162b1, BNT162b2 Dose Ranging, and BNT162c2 Prime/Boost Cohorts.
    End point values
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Number of subjects analysed
    12
    12
    6
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        7 days after Prime Immunization (Day 8)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        21 days after Prime Immunization (Day 22)
    0
    0
    0
    2
    1
    3
    3
    7
    7
    6
    5
    6
    3
    0
    0
    7
    5
    6
    2
    2
    10
    0
    0
    0
    1
        7 days after Boost Immunization (Day 29)
    9999
    9999
    9999
    9999
    11
    9999
    11
    9999
    9999
    9999
    12
    12
    11
    7
    12
    1
    12
    12
    12
    12
    12
    0
    0
    0
    2
        21 days after Boost Immunization (Day 43)
    0
    2
    0
    10
    11
    9
    10
    12
    11
    3
    12
    11
    12
    9
    12
    11
    12
    11
    12
    12
    12
    0
    0
    0
    0
        28 days after Boost Immunization (Day 50)
    0
    9999
    9999
    9999
    11
    9999
    11
    9999
    9999
    9999
    12
    11
    12
    9
    11
    12
    12
    12
    12
    11
    12
    0
    0
    0
    0
        63 days after Boost Immunization (Day 85)
    0
    2
    0
    9
    8
    9
    10
    11
    11
    1
    10
    8
    10
    8
    9
    11
    12
    12
    8
    7
    12
    0
    0
    0
    0
        162 days after Boost Immunization (Day 184)
    0
    1
    0
    3
    6
    4
    7
    8
    10
    0
    5
    7
    10
    3
    2
    6
    10
    11
    7
    4
    10
    0
    0
    1
    2
    No statistical analyses for this end point

    Secondary: Functional Antibody Responses (Titers) for BNT162c2 (SD)

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    End point title
    Functional Antibody Responses (Titers) for BNT162c2 (SD) [9]
    End point description
    At Day 1 (Baseline) and at 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 of cohort 0.1 μg was scheduled before approval of protocol version 7 which implemented this visit.
    End point type
    Secondary
    End point timeframe
    Up to 183 days following Dose 1
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162c2 single dose cohorts.
    End point values
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Number of subjects analysed
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        Pre-Prime Immunization (Day 1)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
        7 days after Prime Immunization (Day 8)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
        21 days after Prime Immunization (Day 22)
    5.1 (4.8 to 5.5)
    5.1 (4.8 to 5.5)
    5.3 (4.7 to 6.0)
    5.5 (4.8 to 6.3)
        28 days after Prime Immunization (Day 29)
    9999 (9999 to 9999)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.2 (4.8 to 5.6)
        42 days after Prime Immunization (Day 43)
    5.1 (4.8 to 5.5)
    5.1 (4.8 to 5.5)
    5.5 (4.5 to 6.6)
    5.1 (4.8 to 5.5)
        84 days after Prime Immunization (Day 85)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    6.0 (4.0 to 9.2)
    5.0 (5.0 to 5.0)
        183 days after Prime Immunization (Day 184)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.5 (4.5 to 6.8)
    6.4 (3.7 to 11.3)
    No statistical analyses for this end point

    Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

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    End point title
    Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) [10]
    End point description
    At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 of cohort 0.1 μg was scheduled before approval of protocol version 7 which implemented this visit.
    End point type
    Secondary
    End point timeframe
    Up to 183 days following Dose 1
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162c2 single dose cohorts.
    End point values
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Number of subjects analysed
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        7 days after Prime Immunization (Day 8)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        21 days after Prime Immunization (Day 22)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
    1.1 (0.9 to 1.2)
    1.1 (1.0 to 1.3)
        28 days after Prime Immunization (Day 29)
    9999 (9999 to 9999)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
        42 days after Prime Immunization (Day 43)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.1)
    1.1 (0.9 to 1.3)
    1.0 (1.0 to 1.1)
        84 days after Prime Immunization (Day 85)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.2 (0.8 to 1.8)
    1.0 (1.0 to 1.0)
        183 days after Prime Immunization (Day 184)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.4)
    1.3 (0.7 to 2.3)
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

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    End point title
    Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) [11]
    End point description
    At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 of cohort 0.1 μg was scheduled before approval of protocol version 7 which implemented this visit.
    End point type
    Secondary
    End point timeframe
    Up to 183 days following Dose 1
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162c2 single dose cohorts.
    End point values
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Number of subjects analysed
    12
    12
    12
    12
    Units: Participants
        7 days after Prime Immunization (Day 8)
    0
    0
    0
    0
        21 days after Prime Immunization (Day 22)
    0
    0
    0
    0
        28 days after Prime Immunization (Day 29)
    9999
    0
    0
    0
        42 days after Prime Immunization (Day 43)
    0
    0
    0
    0
        84 days after Prime Immunization (Day 85)
    0
    0
    1
    0
        183 days after Prime Immunization (Day 184)
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

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    End point title
    Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B) [12]
    End point description
    At Day 1 (Baseline) and at 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as, according to the protocol, Day 15 assessment was only performed for Cohort 14, and Day 36, Day 43, Day 85, and Day 365 assessments were only performed for Cohorts 11, 12, and 13. 999 indicates confidence interval not calculated as values of at least 3 participants were not available. 99999 indicates data not available as all participants crossed-over to study BNT162-14 before reaching Day 365 or were discontinued due to the reception of a non-trial vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 1 year following Dose 1
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162b2 Expansion Cohorts.
    End point values
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Number of subjects analysed
    15
    15
    30
    90
    20
    Units: Titer
    geometric mean (confidence interval 95%)
        Pre-Prime Immunization (Day 1)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.1 (4.9 to 5.3)
    5.0 (5.0 to 5.0)
        7 days after Prime Immunization (Day 8)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.4 (4.8 to 6.0)
    5.3 (4.7 to 6.1)
    6.6 (4.2 to 10.4)
        14 days after Prime Immunization (Day 15)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9.5 (4.8 to 18.7)
        21 days after Prime Immunization (Day 22)
    17.4 (9.8 to 30.9)
    5.2 (4.7 to 5.8)
    5.7 (4.8 to 6.8)
    21.9 (17.5 to 27.3)
    17.9 (9.5 to 33.7)
        7 days after Boost Immunization (Day 29)
    167.6 (112.0 to 250.7)
    12.0 (5.5 to 26.4)
    30.7 (21.3 to 44.1)
    348.6 (270.8 to 448.8)
    286.8 (183.1 to 449.4)
        14 days after Boost Immunization (Day 36)
    206.3 (116.8 to 364.3)
    11.5 (5.3 to 24.8)
    149.3 (104.0 to 214.4)
    379.1 (306.0 to 469.6)
    9999 (9999 to 9999)
        21 days after Boost Immunization (Day 43)
    167.6 (93.8 to 299.2)
    9.8 (4.8 to 19.7)
    119.9 (81.5 to 176.4)
    307.8 (250.0 to 378.9)
    9999 (9999 to 9999)
        28 days after Boost Immunization (Day 50)
    136.1 (76.2 to 243.0)
    11.0 (5.1 to 23.7)
    87.7 (62.3 to 123.7)
    266.5 (215.9 to 328.8)
    103.3 (70.8 to 150.6)
        63 days after Boost Immunization (Day 85)
    50.4 (30.7 to 82.7)
    8.3 (5.0 to 13.7)
    79.1 (56.7 to 110.2)
    99.9 (81.3 to 122.7)
    9999 (9999 to 9999)
        162 days after Boost Immunization (Day 184)
    27.0 (16.3 to 44.6)
    11.9 (4.0 to 35.3)
    19.2 (11.9 to 30.9)
    29.5 (23.5 to 37.1)
    49.8 (33.3 to 74.4)
        343 days after Boost Immunization (Day 365)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    7.1 (-999 to 999)
    30.2 (11.7 to 78.2)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

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    End point title
    Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B) [13]
    End point description
    At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as, according to the protocol, Day 15 assessment was only performed for Cohort 14, and Day 36, Day 43, Day 85, and Day 365 assessments were only performed for Cohorts 11, 12, and 13. 999 indicates confidence interval not calculated as values of at least 3 participants were not available. 99999 indicates data not available as all participants crossed-over to study BNT162-14 before reaching Day 365 or were discontinued due to the reception of a non-trial vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 1 year following Dose 1
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162b2 Expansion Cohorts.
    End point values
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Number of subjects analysed
    15
    15
    30
    90
    20
    Units: Titer
    geometric mean (confidence interval 95%)
        7 days after Prime Immunization (Day 8)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.1 (1.0 to 1.2)
    1.0 (1.0 to 1.1)
    1.3 (0.8 to 2.1)
        14 days after Prime Immunization (Day 15)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    1.9 (1.0 to 3.7)
        21 days after Prime Immunization (Day 22)
    3.5 (2.0 to 6.2)
    1.0 (0.9 to 1.2)
    1.1 (1.0 to 1.4)
    4.3 (3.5 to 5.3)
    3.6 (1.9 to 6.7)
        7 days after Boost Immunization (Day 29)
    33.5 (22.4 to 50.1)
    2.4 (1.1 to 5.3)
    6.1 (4.3 to 8.8)
    68.4 (53.3 to 87.7)
    57.4 (36.6 to 89.9)
        14 days after Boost Immunization (Day 36)
    41.3 (23.4 to 72.9)
    2.3 (1.1 to 5.0)
    29.9 (20.8 to 42.9)
    74.3 (60.2 to 91.8)
    9999 (9999 to 9999)
        21 days after Boost Immunization (Day 43)
    33.5 (18.8 to 59.8)
    2.0 (1.0 to 3.9)
    24.0 (16.3 to 35.3)
    60.4 (49.2 to 74.1)
    9999 (9999 to 9999)
        28 days after Boost Immunization (Day 50)
    27.2 (15.2 to 48.6)
    2.2 (1.0 to 4.7)
    17.5 (12.5 to 24.7)
    52.3 (42.7 to 64.0)
    20.7 (14.2 to 30.1)
        63 days after Boost Immunization (Day 85)
    10.1 (6.1 to 16.5)
    1.7 (1.0 to 2.7)
    15.8 (11.3 to 22.0)
    19.6 (16.0 to 23.9)
    9999 (9999 to 9999)
        162 days after Boost Immunization (Day 184)
    5.4 (3.3 to 8.9)
    2.4 (0.8 to 7.1)
    3.8 (2.4 to 6.2)
    5.8 (4.6 to 7.2)
    10.0 (6.7 to 14.9)
        343 days after Boost Immunization (Day 365)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1.4 (-999 to 999)
    5.4 (2.1 to 13.8)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

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    End point title
    Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B) [14]
    End point description
    At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as, according to the protocol, Day 15 assessment was only performed for Cohort 14, and Day 36, Day 43, Day 85, and Day 365 assessments were only performed for Cohorts 11, 12, and 13. 999 indicates confidence interval not calculated as values of at least 3 participants were not available. 99999 indicates data not available as all participants crossed-over to study BNT162-14 before reaching Day 365 or were discontinued due to the reception of a non-trial vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 1 year following Dose 1
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only reports data for the BNT162b2 Expansion Cohorts.
    End point values
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Number of subjects analysed
    15
    15
    30
    90
    20
    Units: Participants
        7 days after Prime Immunization (Day 8)
    0
    0
    1
    1
    2
        14 days after Prime Immunization (Day 15)
    9999
    9999
    9999
    9999
    4
        21 days after Prime Immunization (Day 22)
    7
    0
    1
    54
    9
        7 days after Boost Immunization (Day 29)
    15
    4
    22
    88
    19
        14 days after Boost Immunization (Day 36)
    15
    4
    30
    88
    9999
        21 days after Boost Immunization (Day 43)
    15
    3
    29
    89
    9999
        28 days after Boost Immunization (Day 50)
    15
    4
    30
    89
    19
        63 days after Boost Immunization (Day 85)
    13
    2
    28
    84
    9999
        162 days after Boost Immunization (Day 184)
    12
    3
    12
    61
    18
        343 days after Boost Immunization (Day 365)
    99999
    99999
    0
    10
    99999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime]) up to Day 387 (approximately 12 months after Dose 2 [Boost]); other AEs: see below in section 'AE reporting additional description'.
    Adverse event reporting additional description
    Timeframe for AE reporting continued: Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), expansion cohort (Cohort 13). ICP = Immunocompromised participants.

    Reporting group title
    BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), expansion cohort (Cohort 13). ICP = Immunocompromised participants, PT = post-transplant.

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11). .

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), adaptive immune response dose group expansion cohort (C12 = Cohort 12).

    Reporting group title
    BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
    Reporting group description
    BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Reporting group title
    BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Reporting group description
    BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

    Serious adverse events
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
    0 / 30 (0.00%)
    3 / 90 (3.33%)
    1 / 20 (5.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 90 (1.11%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 90 (1.11%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 90 (1.11%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pelvic mass
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    1 / 20 (5.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 90 (1.11%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12 BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14 BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 12 (75.00%)
    9 / 12 (75.00%)
    5 / 6 (83.33%)
    9 / 12 (75.00%)
    2 / 12 (16.67%)
    12 / 12 (100.00%)
    6 / 12 (50.00%)
    12 / 12 (100.00%)
    12 / 12 (100.00%)
    12 / 12 (100.00%)
    3 / 12 (25.00%)
    4 / 12 (33.33%)
    9 / 12 (75.00%)
    8 / 12 (66.67%)
    7 / 12 (58.33%)
    12 / 12 (100.00%)
    10 / 12 (83.33%)
    11 / 12 (91.67%)
    4 / 12 (33.33%)
    7 / 12 (58.33%)
    4 / 12 (33.33%)
    3 / 15 (20.00%)
    11 / 15 (73.33%)
    13 / 30 (43.33%)
    48 / 90 (53.33%)
    9 / 20 (45.00%)
    4 / 12 (33.33%)
    5 / 12 (41.67%)
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    10 / 12 (83.33%)
    9 / 12 (75.00%)
    5 / 12 (41.67%)
    11 / 12 (91.67%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    1 / 90 (1.11%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    5 / 90 (5.56%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Systolic hypertension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diastolic hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Dental care
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 90 (1.11%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mole excision
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Papilloma excision
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    2 / 90 (2.22%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
    7 / 12 (58.33%)
    0 / 12 (0.00%)
    6 / 12 (50.00%)
    0 / 12 (0.00%)
    5 / 12 (41.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    4 / 12 (33.33%)
    5 / 12 (41.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    2 / 90 (2.22%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
         occurrences all number
    1
    3
    1
    7
    0
    7
    0
    7
    1
    0
    0
    0
    0
    2
    1
    5
    6
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    3
    5
    2
    3
    Feeling hot
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    3 / 12 (25.00%)
    8 / 12 (66.67%)
    1 / 6 (16.67%)
    4 / 12 (33.33%)
    0 / 12 (0.00%)
    8 / 12 (66.67%)
    0 / 12 (0.00%)
    10 / 12 (83.33%)
    11 / 12 (91.67%)
    10 / 12 (83.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    7 / 12 (58.33%)
    2 / 12 (16.67%)
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    0 / 30 (0.00%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    5
    14
    1
    7
    0
    8
    0
    16
    21
    10
    0
    0
    0
    3
    0
    7
    2
    4
    2
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    2
    2
    0
    2
    Injection site reaction
         subjects affected / exposed
    9 / 12 (75.00%)
    8 / 12 (66.67%)
    1 / 6 (16.67%)
    4 / 12 (33.33%)
    0 / 12 (0.00%)
    8 / 12 (66.67%)
    0 / 12 (0.00%)
    11 / 12 (91.67%)
    12 / 12 (100.00%)
    6 / 12 (50.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    11 / 12 (91.67%)
    9 / 12 (75.00%)
    10 / 12 (83.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 90 (0.00%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    9 / 12 (75.00%)
         occurrences all number
    10
    15
    1
    7
    0
    11
    0
    19
    20
    6
    0
    0
    0
    2
    0
    21
    9
    10
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    1
    2
    3
    9
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    2 / 90 (2.22%)
    0 / 20 (0.00%)
    0 / 12 (0.00%)