Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Interventional, Randomized, Active-Controlled, Phase 1/2/3 Study to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b RNA-Based Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

    Summary
    EudraCT number
    2022-002008-19
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Mar 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Oct 2024
    First version publication date
    12 Oct 2024
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    C4591044
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05472038
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech SE, BioNTech clinical trials patient information, +49 6131 90840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002861-PIP02-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Apr 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate safety, tolerability, and immunogenicity of BNT162b RNA-based vaccine candidates in COVID-19 vaccine–experienced healthy individuals. These candidates included: 1. Cohort 2 and Cohort 3: Omicron BA.4/BA.5 variant-adapted BNT162b2. - BNT162b2 Bivalent (WT/OMI BA.4/BA.5) in participants 12 years and older. Participants 18 and older received either 30 mcg or 60 mcg dose. Some immunogenicity analyses compared to historic study of BNT162b2 30 mcg, or BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg or 60 mcg. 2. Cohort 1 and Cohort 4: BNT162b5, BNT162b6, BNT162b7, containing modified versions of mRNA segments of the spike protein in adults 18 through 55 years of age. - Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2) with BNT162b2 Bivalent (WT/OMI BA.1) as a comparison. - Cohort 4: BNT162b5 Bivalent (WT/OMI BA.4/BA.5), BNT162b6 Bivalent (WT/OMI BA.4/BA.5), BNT162b7 Bivalent (WT/OMI BA.4/BA.5), BNT162b7 Monovalent (OMI BA.4/BA.5) with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) as a comparison.
    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 Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jul 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1451
    Worldwide total number of subjects
    1451
    EEA total number of subjects
    0
    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)
    107
    Adults (18-64 years)
    1144
    From 65 to 84 years
    197
    85 years and over
    3

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Where appropriate, and as per planned analyses, data is summarised and combined for Cohort 2 (C2) and Cohort 3 (C3) 30 micrograms (mcg) groups (G) per age category to provide sufficient power for the immunogenicity hypotheses for each of the age groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Cohort 3 and Cohort 2 (participants 12 through 17 years of age) were open label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
    Arm description
    Participants aged 18-55 years received BNT162b5 Bivalent (wild type [WT]/omicron [OMI] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b5 Bivalent (WT/OMI BA.2)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b5 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1.

    Arm title
    Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Arm description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 Bivalent (WT/OMI BA.1)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1.

    Arm title
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg)
    Arm description
    Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Arm description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg)
    Arm description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1.

    Arm title
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Arm description
    Participants aged more than (>) 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg)
    Arm description
    Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1.

    Arm title
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Arm description
    Participants aged 18-55 years received BNT162b2 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Active comparator

    Investigational medicinal product name
    BNT162b2 Bivalent (Original/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b2 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b2 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Arm description
    Participants aged 18-55 years received BNT162b5 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b5 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b5 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Arm description
    Participants aged 18-55 years received BNT162b6 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b6 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b6 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Arm description
    Participants aged 18-55 years received BNT162b7 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b7 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b7 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Arm title
    C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Arm description
    Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b7 Monovalent (OMI BA.4/BA.5)
    Investigational medicinal product code
    PF-07302048
    Other name
    BNT162b7 RNA-LNP vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BNT162b7 Monovalent (OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1.

    Number of subjects in period 1
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg) C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Started
    104
    102
    107
    313
    110
    306
    102
    62
    62
    60
    60
    63
    Completed
    102
    96
    102
    298
    106
    300
    101
    59
    57
    58
    55
    59
    Not completed
    2
    6
    5
    15
    4
    6
    1
    3
    5
    2
    5
    4
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    1
    3
    1
    6
    1
    3
    -
    2
    3
    1
    2
    2
         Physician decision
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    1
    3
    3
    9
    2
    2
    1
    -
    1
    -
    2
    1
         Protocol deviation
    -
    -
    -
    -
    -
    -
    -
    1
    1
    1
    1
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b5 Bivalent (wild type [WT]/omicron [OMI] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg)
    Reporting group description
    Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged more than (>) 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg)
    Reporting group description
    Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b5 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b6 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b7 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg) C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg) Total
    Number of subjects
    104 102 107 313 110 306 102 62 62 60 60 63 1451
    Age categorical
    Units: Participants
        Adolescents (12-17 years)
    0 0 107 0 0 0 0 0 0 0 0 0 107
        Adults (18-64 years)
    104 102 0 313 110 147 61 62 62 60 60 63 1144
        From 65-84 years
    0 0 0 0 0 157 40 0 0 0 0 0 197
        85 years and over
    0 0 0 0 0 2 1 0 0 0 0 0 3
    Sex: Female, Male
    Units: Participants
        Female
    52 58 48 201 63 167 55 39 31 40 37 38 829
        Male
    52 44 59 112 47 139 47 23 31 20 23 25 622
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 3 0 0 0 0 0 0 3
        Asian
    11 10 3 32 9 8 2 7 10 11 3 7 113
        Native Hawaiian or Other Pacific Islander
    1 2 0 0 0 1 0 0 0 0 0 0 4
        Black or African American
    10 15 9 26 11 48 8 4 11 6 3 4 155
        White
    81 71 91 251 90 243 92 49 40 43 53 52 1156
        More than one race
    1 4 3 4 0 3 0 2 1 0 0 0 18
        Unknown or Not Reported
    0 0 1 0 0 0 0 0 0 0 1 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    18 23 7 39 15 37 11 7 10 7 12 13 199
        Not Hispanic or Latino
    84 79 99 272 94 267 89 55 52 53 48 50 1242
        Unknown or Not Reported
    2 0 1 2 1 2 2 0 0 0 0 0 10

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b5 Bivalent (wild type [WT]/omicron [OMI] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg)
    Reporting group description
    Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged more than (>) 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg)
    Reporting group description
    Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b5 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b6 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b7 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Subject analysis set title
    C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Subject analysis set title
    C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants aged > 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Subject analysis set title
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants aged 18 to 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Subject analysis set title
    18-55 Years (BNT162b2 Bivalent(WT/OMI BA.1)30mcg):C4591031 SSE
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A subset of 100 participants in each age group (18 through 55 years of age, >55 years of age) and dose group (30 mcg, 60 mcg) from C4591031 Substudy E (SSE) expanded cohort who received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg or 60 mcg as a second booster dose were selected for this objective. The subset selected from C4591031 Substudy E included similar percentage of participants with baseline positive SARS-CoV-2 infection status as the groups in Cohort 2 of this study.

    Subject analysis set title
    18-55 Years(BNT162b2 Bivalent[WT/OMI BA.1] 60mcg):C4591031 SSE
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A subset of 100 participants in each age group (18 through 55 years of age, >55 years of age) and dose group (30 mcg, 60 mcg) from C4591031 Substudy E expanded cohort who received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg or 60 mcg as a second booster dose were selected for this objective. The subset selected from C4591031 Substudy E included similar percentage of participants with baseline positive SARS-CoV-2 infection status as the groups in Cohort 2 of this study.

    Subject analysis set title
    >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30mcg):C4591031 SSE
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A subset of 100 participants in each age group (18 through 55 years of age, >55 years of age) and dose group (30 mcg, 60 mcg) from C4591031 Substudy E expanded cohort who received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg or 60 mcg as a second booster dose were selected for this objective. The subset selected from C4591031 Substudy E included similar percentage of participants with baseline positive SARS-CoV-2 infection status as the groups in Cohort 2 of this study.

    Subject analysis set title
    >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60mcg):C4591031 SSE
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A subset of 100 participants in each age group (18 through 55 years of age, >55 years of age) and dose group (30 mcg, 60 mcg) from C4591031 Substudy E expanded cohort who received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg or 60 mcg as a second booster dose were selected for this objective. The subset selected from C4591031 Substudy E included similar percentage of participants with baseline positive SARS-CoV-2 infection status as the groups in Cohort 2 of this study.

    Subject analysis set title
    BNT162b2 30 mcg: C4591031 Substudy E
    Subject analysis set type
    Per protocol
    Subject analysis set description
    BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.

    Primary: Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination [1] [2]
    End point description
    Local reactions recorded by participants in electronic diary (e-diary). Local reactions: redness, swelling, pain at injection site. Redness, swelling graded mild: > 2.0-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, grade 4: necrosis/exfoliative dermatitis (redness), necrosis (swelling). Pain at injection site graded mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room (ER) visit/hospitalisation. Grade 4 reactions (potentially life threatening) classified by investigator/medically qualified person. Any events recorded on the adverse event (AE) case report form (CRF) that are considered local reactions within 7 days after vaccination were consolidated with e-diary data and included in the reactogenicity report. Safety population: all participants receiving study intervention and obtaining informed consent.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    104
    102
    Units: Percentage of participants
    number (confidence interval 95%)
        Redness: Any
    5.8 (2.1 to 12.1)
    5.9 (2.2 to 12.4)
        Redness: Mild
    3.8 (1.1 to 9.6)
    3.9 (1.1 to 9.7)
        Redness: Moderate
    1.0 (0.0 to 5.2)
    2.0 (0.2 to 6.9)
        Redness: Severe
    1.0 (0.0 to 5.2)
    0 (0.0 to 3.6)
        Redness: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Swelling: Any
    10.6 (5.4 to 18.1)
    10.8 (5.5 to 18.5)
        Swelling: Mild
    6.7 (2.7 to 13.4)
    4.9 (1.6 to 11.1)
        Swelling: Moderate
    2.9 (0.6 to 8.2)
    5.9 (2.2 to 12.4)
        Swelling: Severe
    1.0 (0.0 to 5.2)
    0 (0.0 to 3.6)
        Swelling: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Pain at injection site: Any
    82.7 (74.0 to 89.4)
    81.4 (72.4 to 88.4)
        Pain at injection site: Mild
    67.3 (57.4 to 76.2)
    62.7 (52.6 to 72.1)
        Pain at injection site: Moderate
    15.4 (9.1 to 23.8)
    18.6 (11.6 to 27.6)
        Pain at injection site: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Pain at injection site: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
    No statistical analyses for this end point

    Primary: Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination [3] [4]
    End point description
    Systemic events recorded by participants in e-diary. Fever: oral temperature >= 38 degree Celsius (deg C), categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C, >40.0 deg C. Fatigue, headache, chills, new/worsened muscle pain, new/worsened joint pain= mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity. Vomiting= mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhea= mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6/more loose stools in 24h. Except fever, Grade 4= ER visit/hospitalisation. Grade 4 events classified by investigator/medically qualified person. Systemic events reported as AEs in CRF within 7 days after vaccination included. Safety population= participants receiving study intervention and obtaining informed consent.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    104
    102
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Any
    1.9 (0.2 to 6.8)
    5.9 (2.2 to 12.4)
        Fever: >=38.0 deg C to 38.4 deg C
    1.0 (0.0 to 5.2)
    2.0 (0.2 to 6.9)
        Fever: >38.4 deg C to 38.9 deg C
    0 (0.0 to 3.5)
    1.0 (0.0 to 5.3)
        Fever: >38.9 deg C to 40.0 deg C
    1.0 (0.0 to 5.2)
    2.9 (0.6 to 8.4)
        Fever: >40.0 deg C
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Fatigue: Any
    73.1 (63.5 to 81.3)
    62.7 (52.6 to 72.1)
        Fatigue: Mild
    37.5 (28.2 to 47.5)
    27.5 (19.1 to 37.2)
        Fatigue: Moderate
    34.6 (25.6 to 44.6)
    34.3 (25.2 to 44.4)
        Fatigue: Severe
    1.0 (0.0 to 5.2)
    1.0 (0.0 to 5.3)
        Fatigue: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Headache: Any
    52.9 (42.8 to 62.8)
    46.1 (36.2 to 56.2)
        Headache: Mild
    29.8 (21.2 to 39.6)
    22.5 (14.9 to 31.9)
        Headache: Moderate
    21.2 (13.8 to 30.3)
    22.5 (14.9 to 31.9)
        Headache: Severe
    1.9 (0.2 to 6.8)
    1.0 (0.0 to 5.3)
        Headache: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Chills: Any
    21.2 (13.8 to 30.3)
    19.6 (12.4 to 28.6)
        Chills: Mild
    10.6 (5.4 to 18.1)
    7.8 (3.4 to 14.9)
        Chills: Moderate
    10.6 (5.4 to 18.1)
    11.8 (6.2 to 19.6)
        Chills: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Chills: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Vomiting: Any
    1.0 (0.0 to 5.2)
    2.0 (0.2 to 6.9)
        Vomiting: Mild
    1.0 (0.0 to 5.2)
    2.0 (0.2 to 6.9)
        Vomiting: Moderate
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Vomiting: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Vomiting: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        Diarrhea: Any
    14.4 (8.3 to 22.7)
    19.6 (12.4 to 28.6)
        Diarrhea: Mild
    13.5 (7.6 to 21.6)
    14.7 (8.5 to 23.1)
        Diarrhea: Moderate
    1.0 (0.0 to 5.2)
    3.9 (1.1 to 9.7)
        Diarrhea: Severe0
    0 (0.0 to 3.5)
    1.0 (0.0 to 5.3)
        Diarrhea: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        New or worsened muscle pain: Any
    35.6 (26.4 to 45.6)
    38.2 (28.8 to 48.4)
        New or worsened muscle pain: Mild
    18.3 (11.4 to 27.1)
    23.5 (15.7 to 33.0)
        New or worsened muscle pain: Moderate
    17.3 (10.6 to 26.0)
    14.7 (8.5 to 23.1)
        New or worsened muscle pain: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        New or worsened joint pain: Any
    18.3 (11.4 to 27.1)
    17.6 (10.8 to 26.4)
        New or worsened joint pain: Mild
    7.7 (3.4 to 14.6)
    11.8 (6.2 to 19.6)
        New or worsened joint pain: Moderate
    10.6 (5.4 to 18.1)
    5.9 (2.2 to 12.4)
        New or worsened joint pain: Severe
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
        New or worsened joint pain: Grade 4
    0 (0.0 to 3.5)
    0 (0.0 to 3.6)
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Cohort 1: Percentage of Participants With Adverse Events (AEs) From Study Vaccination Through 1 Month After Study Vaccination [5] [6]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
    End point type
    Primary
    End point timeframe
    From study vaccination on Day 1 through 1 month after study vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    104
    102
    Units: Percentage of participants
        number (confidence interval 95%)
    8.7 (4.0 to 15.8)
    12.7 (7.0 to 20.8)
    No statistical analyses for this end point

    Primary: Cohort 1: Percentage of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination

    Close Top of page
    End point title
    Cohort 1: Percentage of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination [7] [8]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
    End point type
    Primary
    End point timeframe
    From study vaccination on Day 1 through 6 months after study vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    104
    102
    Units: Percentage of participants
        number (confidence interval 95%)
    1.0 (0.0 to 5.2)
    2.0 (0.2 to 6.9)
    No statistical analyses for this end point

    Primary: Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralising Titers (NTs) at Baseline- Participants Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralising Titers (NTs) at Baseline- Participants Without Evidence of Infection [9] [10]
    End point description
    GMTs and the corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Evaluable immunogenicity population (EIP) included all eligible randomised/assigned participants who received the study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Analysis was performed in participants without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    At baseline (before study vaccination)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    30
    29
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.2 (n=29, 29)
    169.3 (96.7 to 296.3)
    377.8 (229.2 to 622.8)
        Omicron BA.1 (n=30, 29)
    103.3 (60.4 to 176.6)
    209.5 (147.2 to 298.2)
        Reference strain (n=30, 29)
    892.0 (526.5 to 1511.3)
    1544.2 (993.8 to 2399.4)
    No statistical analyses for this end point

    Primary: Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month- Participants Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month- Participants Without Evidence of Infection [11] [12]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Evaluable immunogenicity population included all eligible randomised/assigned participants who received the study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Analysis was performed in participants without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    30
    29
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.2 (n=30, 28)
    2414.8 (1508.5 to 3865.4)
    2768.5 (1948.5 to 3933.7)
        Omicron BA.1 (n=30, 29)
    1666.1 (1085.8 to 2556.6)
    1993.8 (1309.1 to 3036.6)
        Reference strain (n=30, 29)
    8268.9 (5901.9 to 11585.1)
    7391.6 (5117.5 to 10676.2)
    No statistical analyses for this end point

    Primary: Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection [13] [14]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Evaluable immunogenicity population included all eligible randomised/assigned participants who received the study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    At baseline (before study vaccination)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    103
    98
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.2 (n=102, 96)
    1269.1 (854.7 to 1884.6)
    1527.5 (1061.3 to 2198.6)
        Omicron BA.1 (n=103, 98)
    652.7 (448.9 to 949.0)
    818.7 (595.9 to 1124.7)
        Reference strain (n=103, 98)
    3469.8 (2536.5 to 4746.7)
    3755.9 (2896.8 to 4869.9)
    No statistical analyses for this end point

    Primary: Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection [15] [16]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Evaluable immunogenicity population included all eligible randomised/assigned participants who received the study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    103
    98
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.2 (n=102, 95)
    6267.9 (4766.0 to 8243.1)
    4984.2 (3976.4 to 6247.4)
        Omicron BA.1 (n=103, 98)
    3582.2 (2813.7 to 4560.7)
    3571.8 (2899.6 to 4399.8)
        Reference strain (n=103, 98)
    14342.3 (11811.9 to 17414.9)
    11246.8 (9395.1 to 13463.6)
    No statistical analyses for this end point

    Primary: Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection [17] [18]
    End point description
    GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralising titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in analysis. EIP included all eligible randomised/assigned participants who received study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, and had no other important protocol deviations as determined by clinician. Analysis was performed in participants without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    From before the study vaccination to 1 month after the study vaccination
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    30
    29
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Omicron BA.2 (n= 29, 28)
    14.6 (8.4 to 25.5)
    6.9 (4.4 to 10.9)
        Omicron BA.1 (n= 30, 29)
    16.1 (10.9 to 23.9)
    9.5 (6.5 to 13.8)
        Reference strain (n= 30, 29)
    9.3 (5.9 to 14.6)
    4.8 (3.1 to 7.3)
    No statistical analyses for this end point

    Primary: Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection [19] [20]
    End point description
    GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralising titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5*LLOQ in analysis. EIP included all eligible randomised/assigned participants who received study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, and had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    From before the study vaccination to 1 month after the study vaccination
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    103
    98
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Omicron BA.2 (n=101, 93)
    5.0 (3.6 to 6.8)
    3.2 (2.3 to 4.3)
        Omicron BA.1 (n=103, 98)
    5.5 (4.3 to 7.1)
    4.4 (3.4 to 5.6)
        Reference strain (n=103, 98)
    4.1 (3.3 to 5.2)
    3.0 (2.4 to 3.7)
    No statistical analyses for this end point

    Primary: Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain– NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain– NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection [21] [22]
    End point description
    Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. EIP included all eligible randomised/assigned participants who received study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, and had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    103
    98
    Units: Percentage of participants
    number (confidence interval 95%)
        Omicron BA.2 (n=101, 93)
    53.5 (43.3 to 63.5)
    40.9 (30.8 to 51.5)
        Omicron BA.1 (n=103, 98)
    58.3 (48.1 to 67.9)
    49.0 (38.7 to 59.3)
        Reference strain (n=103, 98)
    43.7 (33.9 to 53.8)
    30.6 (21.7 to 40.7)
    No statistical analyses for this end point

    Primary: Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain– NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain– NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection [23] [24]
    End point description
    Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. EIP included all eligible randomised/assigned participants who received study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, and had no other important protocol deviations as determined by clinician. Analysis was performed in participants without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 1 reporting groups only.
    End point values
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Number of subjects analysed
    30
    29
    Units: Percentage of participants
    number (confidence interval 95%)
        Omicron BA.2 (n=29, 28)
    82.8 (64.2 to 94.2)
    71.4 (51.3 to 86.8)
        Omicron BA.1 (n=30, 29)
    93.3 (77.9 to 99.2)
    86.2 (68.3 to 96.1)
        Reference (n=30, 29)
    73.3 (54.1 to 87.7)
    51.7 (32.5 to 70.6)
    No statistical analyses for this end point

    Primary: Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination [25] [26]
    End point description
    Local reactions recorded by participants in e-diary. Local reactions: redness, swelling, pain at injection (inj) site. Redness, swelling graded mild: > 2.0-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis/exfoliative dermatitis (redness), necrosis (swelling). Pain at inj site graded mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4 (potentially life threatening): ER visit/hospitalisation. Grade 4 reactions classified by investigator/medically qualified person. Reactions reported as AEs in CRF within 7 days after study vaccination reported. Safety population: all participants receiving study intervention and obtaining informed consent. "Number of Participants Analysed"=participants evaluable for endpoint; “n''=participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    107
    110
    102
    102
    105
    Units: Percentage of participants
    number (confidence interval 95%)
        Redness: Any (n=107,110,101,102,105)
    5.6 (2.1 to 11.8)
    10.9 (5.8 to 18.3)
    6.9 (2.8 to 13.8)
    5.9 (2.2 to 12.4)
    2.9 (0.6 to 8.1)
        Redness: Mild (n=107,110,101,102,105)
    3.7 (1.0 to 9.3)
    5.5 (2.0 to 11.5)
    4.0 (1.1 to 9.8)
    4.9 (1.6 to 11.1)
    1.0 (0.0 to 5.2)
        Redness: Moderate (n=107,110,101,102,105)
    1.9 (0.2 to 6.6)
    4.5 (1.5 to 10.3)
    3.0 (0.6 to 8.4)
    1.0 (0.0 to 5.3)
    1.9 (0.2 to 6.7)
        Redness: Severe (n=107,110,101,102,105)
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Redness: Grade 4 (n=107,110,101,102,105)
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Swelling: Any (n=107,110,101,102,105)
    7.5 (3.3 to 14.2)
    15.5 (9.3 to 23.6)
    8.9 (4.2 to 16.2)
    6.9 (2.8 to 13.6)
    1.9 (0.2 to 6.7)
        Swelling: Mild (n=107,110,101,102,105)
    5.6 (2.1 to 11.8)
    6.4 (2.6 to 12.7)
    5.0 (1.6 to 11.2)
    4.9 (1.6 to 11.1)
    1.0 (0.0 to 5.2)
        Swelling: Moderate (n=107,110,101,102,105)
    1.9 (0.2 to 6.6)
    9.1 (4.4 to 16.1)
    4.0 (1.1 to 9.8)
    2.0 (0.2 to 6.9)
    1.0 (0.0 to 5.2)
        Swelling: Severe (n=107,110,101,102,105)
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Swelling: Grade 4 (n=107,110,101,102,105)
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Pain at inj site: Any (n=107,110,102,102,105)
    70.1 (60.5 to 78.6)
    93.6 (87.3 to 97.4)
    70.6 (60.7 to 79.2)
    79.4 (70.3 to 86.8)
    56.2 (46.2 to 65.9)
        Pain at inj site: Mild (n=107,110,102,102,105)
    42.1 (32.6 to 52.0)
    53.6 (43.9 to 63.2)
    52.9 (42.8 to 62.9)
    63.7 (53.6 to 73.0)
    50.5 (40.5 to 60.4)
        Pain at inj site: Moderate (n=107,110,102,102,105)
    27.1 (19.0 to 36.6)
    40.0 (30.8 to 49.8)
    17.6 (10.8 to 26.4)
    15.7 (9.2 to 24.2)
    5.7 (2.1 to 12.0)
        Pain at inj site: Severe (n=107,110,102,102,105)
    0.9 (0.0 to 5.1)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Pain at inj site: Grade 4 (n=107,110,102,102,105)
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
    No statistical analyses for this end point

    Primary: Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination [27] [28]
    End point description
    Systemic events recorded by participants in e-diary. Fever: oral temperature >= 38 deg C, categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C, >40.0 deg C. Fatigue, headache, chills, new/worsened muscle pain, new/worsened joint pain= mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity. Vomiting= mild: 1-2 times in 24 h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea= mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6/more loose stools in 24h. Except fever, Grade 4= ER visit/hospitalisation. Grade 4 events classified by investigator/medically qualified person. Systemic events reported as AEs in CRF within 7 days after vaccination included. Safety population= participants receiving study intervention and obtaining IC. "Number of Participants Analysed" =participants evaluable for endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    107
    110
    101
    102
    105
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Any
    9.3 (4.6 to 16.5)
    11.8 (6.4 to 19.4)
    13.9 (7.8 to 22.2)
    4.9 (1.6 to 11.1)
    7.6 (3.3 to 14.5)
        Fever: >=38.0 deg C to 38.4 deg C
    6.5 (2.7 to 13.0)
    7.3 (3.2 to 13.8)
    7.9 (3.5 to 15.0)
    2.0 (0.2 to 6.9)
    5.7 (2.1 to 12.0)
        Fever: >38.4 deg C to 38.9 deg C
    1.9 (0.2 to 6.6)
    2.7 (0.6 to 7.8)
    4.0 (1.1 to 9.8)
    2.9 (0.6 to 8.4)
    1.9 (0.2 to 6.7)
        Fever: >38.9 deg C to 40.0 deg C
    0.9 (0.0 to 5.1)
    1.8 (0.2 to 6.4)
    2.0 (0.2 to 7.0)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Fever: >40.0 deg C
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Fatigue: Any
    67.3 (57.5 to 76.0)
    69.1 (59.6 to 77.6)
    53.5 (43.3 to 63.5)
    62.7 (52.6 to 72.1)
    39.0 (29.7 to 49.1)
        Fatigue: Mild
    25.2 (17.3 to 34.6)
    24.5 (16.8 to 33.7)
    23.8 (15.9 to 33.3)
    30.4 (21.7 to 40.3)
    20.0 (12.8 to 28.9)
        Fatigue: Moderate
    42.1 (32.6 to 52.0)
    43.6 (34.2 to 53.4)
    25.7 (17.6 to 35.4)
    30.4 (21.7 to 40.3)
    18.1 (11.3 to 26.8)
        Fatigue: Severe
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    4.0 (1.1 to 9.8)
    2.0 (0.2 to 6.9)
    1.0 (0.0 to 5.2)
        Fatigue: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Headache: Any
    50.5 (40.6 to 60.3)
    45.5 (35.9 to 55.2)
    35.6 (26.4 to 45.8)
    44.1 (34.3 to 54.3)
    29.5 (21.0 to 39.2)
        Headache: Mild
    26.2 (18.1 to 35.6)
    27.3 (19.2 to 36.6)
    20.8 (13.4 to 30.0)
    32.4 (23.4 to 42.3)
    21.9 (14.4 to 31.0)
        Headache: Moderate
    24.3 (16.5 to 33.5)
    17.3 (10.7 to 25.7)
    13.9 (7.8 to 22.2)
    11.8 (6.2 to 19.6)
    7.6 (3.3 to 14.5)
        Headache: Severe
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    1.0 (0.0 to 5.4)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Headache: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Chills: Any
    23.4 (15.7 to 32.5)
    27.3 (19.2 to 36.6)
    22.8 (15.0 to 32.2)
    14.7 (8.5 to 23.1)
    12.4 (6.8 to 20.2)
        Chills: Mild
    17.8 (11.0 to 26.3)
    17.3 (10.7 to 25.7)
    11.9 (6.3 to 19.8)
    8.8 (4.1 to 16.1)
    6.7 (2.7 to 13.3)
        Chills: Moderate
    5.6 (2.1 to 11.8)
    9.1 (4.4 to 16.1)
    10.9 (5.6 to 18.7)
    5.9 (2.2 to 12.4)
    5.7 (2.1 to 12.0)
        Chills: Severe
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Chills: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Vomiting: Any
    2.8 (0.6 to 8.0)
    1.8 (0.2 to 6.4)
    3.0 (0.6 to 8.4)
    2.0 (0.2 to 6.9)
    1.0 (0.0 to 5.2)
        Vomiting: Mild
    2.8 (0.6 to 8.0)
    0.9 (0.0 to 5.0)
    2.0 (0.2 to 7.0)
    1.0 (0.0 to 5.3)
    1.0 (0.0 to 5.2)
        Vomiting: Moderate
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    1.0 (0.0 to 5.4)
    1.0 (0.0 to 5.3)
    0 (0.0 to 3.5)
        Vomiting: Severe
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Vomiting: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        Diarrhea: Any
    6.5 (2.7 to 13.0)
    12.7 (7.1 to 20.4)
    6.9 (2.8 to 13.8)
    13.7 (7.7 to 22.0)
    8.6 (4.0 to 15.6)
        Diarrhea: Mild
    6.5 (2.7 to 13.0)
    11.8 (6.4 to 19.4)
    5.9 (2.2 to 12.5)
    9.8 (4.8 to 17.3)
    8.6 (4.0 to 15.6)
        Diarrhea: Moderate
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    1.0 (0.0 to 5.4)
    2.9 (0.6 to 8.4)
    0 (0.0 to 3.5)
        Diarrhea: Severe
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    1.0 (0.0 to 5.3)
    0 (0.0 to 3.5)
        Diarrhea: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        New or worsened muscle pain: Any
    26.2 (18.1 to 35.6)
    41.8 (32.5 to 51.6)
    22.8 (15.0 to 32.2)
    31.4 (22.5 to 41.3)
    20.0 (12.8 to 28.9)
        New or worsened muscle pain: Mild
    11.2 (5.9 to 18.8)
    21.8 (14.5 to 30.7)
    12.9 (7.0 to 21.0)
    17.6 (10.8 to 26.4)
    12.4 (6.8 to 20.2)
        New or worsened muscle pain: Moderate
    15.0 (8.8 to 23.1)
    19.1 (12.2 to 27.7)
    8.9 (4.2 to 16.2)
    13.7 (7.7 to 22.0)
    7.6 (3.3 to 14.5)
        New or worsened muscle pain: Severe
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    1.0 (0.0 to 5.4)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        New or worsened joint pain: Any
    12.1 (6.6 to 19.9)
    24.5 (16.8 to 33.7)
    14.9 (8.6 to 23.3)
    16.7 (10.0 to 25.3)
    11.4 (6.0 to 19.1)
        New or worsened joint pain: Mild
    8.4 (3.9 to 15.4)
    11.8 (6.4 to 19.4)
    5.9 (2.2 to 12.5)
    9.8 (4.8 to 17.3)
    6.7 (2.7 to 13.3)
        New or worsened joint pain: Moderate
    3.7 (1.0 to 9.3)
    11.8 (6.4 to 19.4)
    7.9 (3.5 to 15.0)
    6.9 (2.8 to 13.6)
    4.8 (1.6 to 10.8)
        New or worsened joint pain: Severe
    0 (0.0 to 3.4)
    0.9 (0.0 to 5.0)
    1.0 (0.0 to 5.4)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
        New or worsened joint pain: Grade 4
    0 (0.0 to 3.4)
    0 (0.0 to 3.3)
    0 (0.0 to 3.6)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
    No statistical analyses for this end point

    Primary: Cohort 2: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination

    Close Top of page
    End point title
    Cohort 2: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination [29] [30]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
    End point type
    Primary
    End point timeframe
    From study vaccination through 6 months after study vaccination
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    107
    110
    102
    103
    106
    Units: Percentage of participants
        number (confidence interval 95%)
    0.9 (0.0 to 5.1)
    0.9 (0.0 to 5.0)
    0 (0.0 to 3.6)
    0 (0.0 to 3.5)
    3.8 (1.0 to 9.4)
    No statistical analyses for this end point

    Primary: Cohort 2: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination

    Close Top of page
    End point title
    Cohort 2: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination [31] [32]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
    End point type
    Primary
    End point timeframe
    From study vaccination through 1 month after study vaccination
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    107
    110
    102
    103
    106
    Units: Percentage of participants
        number (confidence interval 95%)
    7.5 (3.3 to 14.2)
    8.2 (3.8 to 15.0)
    6.9 (2.8 to 13.6)
    2.9 (0.6 to 8.3)
    3.8 (1.0 to 9.4)
    No statistical analyses for this end point

    Primary: Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination [33] [34]
    End point description
    Local reactions recorded by participants in e-diary. Local reactions: redness, swelling, pain at injection site. Redness, swelling graded mild: >2.0-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, grade 4: necrosis/exfoliative dermatitis (redness), necrosis (swelling). Pain at injection site graded mild: did not interfere with activity, moderate: interfered with activity, severe: prevented daily activity, grade 4: ER visit/hospitalisation. Grade 4 reactions (potentially life threatening) classified by investigator/medically qualified person. Reactions reported as AEs in CRF within 7 days after study vaccination included. Safety population: all participants receiving study intervention and obtaining appropriate informed consent. "Number of Participants Analysed"=participants evaluable for the endpoint, ‘’n’’=participants evaluable for specified rows. Endpoint was planned to be analysed in participants combined from C2 G2 + C3 G1 and C2 G4 + C3 G2.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Number of subjects analysed
    310
    301
    Units: Percentage of participants
    number (confidence interval 95%)
        Redness: Any (n=309,300)
    6.5 (4.0 to 9.8)
    4.0 (2.1 to 6.9)
        Redness: Mild (n=309,300)
    4.9 (2.7 to 7.9)
    2.3 (0.9 to 4.7)
        Redness: Moderate (n=309,300)
    1.6 (0.5 to 3.7)
    1.7 (0.5 to 3.8)
        Redness: Severe (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Redness: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Swelling: Any (n=309,300)
    7.1 (4.5 to 10.6)
    2.7 (1.2 to 5.2)
        Swelling: Mild (n=309,300)
    5.8 (3.5 to 9.1)
    1.7 (0.5 to 3.8)
        Swelling: Moderate (n=309,300)
    1.3 (0.4 to 3.3)
    1.0 (0.2 to 2.9)
        Swelling: Severe (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Swelling: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Pain at the injection site: Any (n=310,301)
    76.1 (71.0 to 80.8)
    57.1 (51.3 to 62.8)
        Pain at the injection site: Mild (n=310,301)
    57.4 (51.7 to 63.0)
    48.8 (43.1 to 54.6)
        Pain at the injection site: Moderate (n=310,301)
    18.7 (14.5 to 23.5)
    8.0 (5.2 to 11.6)
        Pain at the injection site: Severe (n=310,301)
    0 (0.0 to 1.2)
    0.3 (0.0 to 1.8)
        Pain at the injection site: Grade 4 (n=310,301)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
    No statistical analyses for this end point

    Primary: Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination [35] [36]
    End point description
    Systemic events recorded in e-diary. Fever: oral temperature>=38 degC, categorised:>=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC, >40.0 degC. Fatigue, headache, chills, new/worsened muscle pain, new/worsened joint pain: mild (didn’t interfere activity), moderate (some interference in activity), severe (prevented daily routine activity). Vomiting: mild (1-2 times in 24h), moderate (>2 times in 24h), severe (required IV hydration). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h), severe (6 or more loose stools in 24h). Except fever, Grade 4= ER visit/hospitalisation. Grade 4 events classified by investigator/medically qualified person. Systemic events reported as AEs in CRF within 7 days post vaccination. Safety population evaluated. "Number of Participants analysed" (N)= participants evaluable for the endpoint, '’n''=participants evaluable for specified rows. Endpoint planned to be analysed in participants combined from C2G2 + C3G1 and C2G4 + C3G2.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2 + 3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Number of subjects analysed
    309
    301
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Any (n=309,300)
    4.9 (2.7 to 7.9)
    4.3 (2.3 to 7.3)
        Fever: >=38.0 deg C to 38.4 deg C (n=309,300)
    2.9 (1.3 to 5.5)
    3.3 (1.6 to 6.0)
        Fever: >38.4 deg C to 38.9 deg C (n=309,300)
    1.9 (0.7 to 4.2)
    1.0 (0.2 to 2.9)
        Fever: >38.9 deg C to 40.0 deg C (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Fever: >40.0 deg C (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Fatigue: Any (n=309,301)
    61.2 (55.5 to 66.6)
    38.5 (33.0 to 44.3)
        Fatigue: Mild (n=309,301)
    26.9 (22.0 to 32.2)
    18.6 (14.4 to 23.5)
        Fatigue: Moderate (n=309,301)
    32.4 (27.2 to 37.9)
    18.6 (14.4 to 23.5)
        Fatigue: Severe (n=309,301)
    1.9 (0.7 to 4.2)
    1.3 (0.4 to 3.4)
        Fatigue: Grade 4 (n=309,301)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Headache: Any (n=309,300)
    46.6 (40.9 to 52.3)
    30.7 (25.5 to 36.2)
        Headache: Mild (n=309,300)
    28.2 (23.2 to 33.5)
    20.7 (16.2 to 25.7)
        Headache: Moderate (n=309,300)
    17.8 (13.7 to 22.5)
    10.0 (6.8 to 14.0)
        Headache: Severe (n=309,300)
    0.6 (0.1 to 2.3)
    0 (0.0 to 1.2)
        Headache: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Chills: Any (n=309,300)
    22.0 (17.5 to 27.0)
    12.0 (8.5 to 16.2)
        Chills: Mild (n=309,300)
    12.3 (8.9 to 16.5)
    7.0 (4.4 to 10.5)
        Chills: Moderate (n=309,300)
    9.1 (6.1 to 12.8)
    4.7 (2.6 to 7.7)
        Chills: Severe (n=309,300)
    0.6 (0.1 to 2.3)
    0.3 (0.0 to 1.8)
        Chills: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Vomiting: Any (n=309,300)
    1.9 (0.7 to 4.2)
    0.7 (0.1 to 2.4)
        Vomiting: Mild (n=309,300)
    1.6 (0.5 to 3.7)
    0.7 (0.1 to 2.4)
        Vomiting: Moderate (n=309,300)
    0.3 (0.0 to 1.8)
    0 (0.0 to 1.2)
        Vomiting: Severe (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Vomiting: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        Diarrhea: Any (n=309,301)
    10.7 (7.5 to 14.7)
    9.6 (6.5 to 13.5)
        Diarrhea: Mild (n=309,301)
    8.7 (5.8 to 12.5)
    7.6 (4.9 to 11.2)
        Diarrhea: Moderate (n=309,301)
    1.6 (0.5 to 3.7)
    2.0 (0.7 to 4.3)
        Diarrhea: Severe (n=309,301)
    0.3 (0.0 to 1.8)
    0 (0.0 to 1.2)
        Diarrhea: Grade 4 (n=309,301)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        New or worsened muscle pain: Any (n=309,300)
    30.4 (25.3 to 35.9)
    18.0 (13.8 to 22.8)
        New or worsened muscle pain: Mild (n=309,300)
    15.2 (11.4 to 19.7)
    10.0 (6.8 to 14.0)
        New or worsened muscle pain: Moderate (n=309,300)
    15.2 (11.4 to 19.7)
    8.0 (5.2 to 11.7)
        New or worsened muscle pain: Severe (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        New or worsened muscle pain: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        New or worsened joint pain: Any (n=309,300)
    14.9 (11.1 to 19.4)
    12.0 (8.5 to 16.2)
        New or worsened joint pain: Mild (n=309,300)
    6.8 (4.3 to 10.2)
    6.7 (4.1 to 10.1)
        New or worsened joint pain: Moderate (n=309,300)
    8.1 (5.3 to 11.7)
    5.3 (3.1 to 8.5)
        New or worsened joint pain: Severe (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
        New or worsened joint pain: Grade 4 (n=309,300)
    0 (0.0 to 1.2)
    0 (0.0 to 1.2)
    No statistical analyses for this end point

    Primary: Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination

    Close Top of page
    End point title
    Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination [37] [38]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. The endpoint was planned per protocol to be analysed in participants combined from Cohort 2 Group 2 + Cohort 3 Group 1 and Cohort 2 Group 4 + Cohort 3 Group 2.
    End point type
    Primary
    End point timeframe
    From study vaccination through 6 months after study vaccination
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2 + 3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Number of subjects analysed
    313
    306
    Units: Percentage of participants
        number (confidence interval 95%)
    0.6 (0.1 to 2.3)
    3.3 (1.6 to 5.9)
    No statistical analyses for this end point

    Primary: Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination

    Close Top of page
    End point title
    Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination [39] [40]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. The endpoint was planned per protocol to be analysed in participants combined from Cohort 2 Group 2 + Cohort 3 Group 1 and Cohort 2 Group 4 + Cohort 3 Group 2.
    End point type
    Primary
    End point timeframe
    From study vaccination through 1 month after study vaccination
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Number of subjects analysed
    313
    306
    Units: Percentage of participants
        number (confidence interval 95%)
    6.1 (3.7 to 9.3)
    6.9 (4.3 to 10.3)
    No statistical analyses for this end point

    Primary: GMR of Omicron (BA.4/BA.5)– NTs of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg C2 G4/C3 G2 Combined in C4591044 Compared to NT of BNT162b2 30 mcg in C4591031– 1 Month After Vaccination Among Participants >55 Years of Age

    Close Top of page
    End point title
    GMR of Omicron (BA.4/BA.5)– NTs of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg C2 G4/C3 G2 Combined in C4591044 Compared to NT of BNT162b2 30 mcg in C4591031– 1 Month After Vaccination Among Participants >55 Years of Age [41]
    End point description
    Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30 mcg groups of C4591044 C2/3 combined and BNT162b2 30 mcg of C4591031 Substudy E in participants >55 years = descriptive data. GMTs and 95% CIs were calculated by exponentiating least square (LS) means and corresponding CI based on analysis of logarithmically transformed NT using linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ=0.5*LLOQ. Model based geometric mean ratio (GMR) = statistical section: OMI BA.4/BA.5 NTs induced 1 month post BNT162b2 Bivalent vaccination in C4591044 to 1 month post BNT162b2 vaccination in C4591031 in participants >55 years. Endpoint was planned to be analysed in participants of C2G4 + C3G2 of C4591044 and BNT162b2 experienced participants of study C4591031 (control arm). Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. "N"=participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 month after study vaccination
    Notes
    [41] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2 + 3 reporting groups only.
    End point values
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects analysed
    282
    273
    Units: Titer
        geometric mean (confidence interval 95%)
    3373.4 (3000.3 to 3793.0)
    1160.7 (1030.3 to 1307.7)
    Statistical analysis title
    C2 (G4)+C3 (G2): >55 Years Vs C4591031 Substudy E
    Statistical analysis description
    Superiority based on model-based GMR was declared if the lower limit of the 2-sided 95% CI for the model-based GMR was greater than 1.
    Comparison groups
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) v BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects included in analysis
    555
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    Model-Based GMR
    Point estimate
    2.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.45
         upper limit
    3.44

    Primary: Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg C2 G4/C3 G2 Combined in C4591044 and for BNT162b2 30 mcg in C4591031– 1 Month After Vaccination Among Participants >55 Years of Age

    Close Top of page
    End point title
    Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg C2 G4/C3 G2 Combined in C4591044 and for BNT162b2 30 mcg in C4591031– 1 Month After Vaccination Among Participants >55 Years of Age [42]
    End point description
    Seroresponse: achieving >= 4-fold rise in NTs from baseline (before study vaccination). If baseline measurement was below LLOQ, postvaccination measure of >= 4*LLOQ was considered seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined and BNT 30 mcg in Study C4591031 [NCT04955626] Substudy E in participants >55 years presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT 30 mcg 1 month after vaccination in study C4591044 and 1 month after BNT vaccination in study C4591031 in participants >55 years reported in statistical section. Endpoint was planned to be analysed in participants from C2 G4 + C3 G2 and BNT experienced participants >55 years from study C4591031 Substudy E (control arm). Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. "N" = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 month after study vaccination
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects analysed
    282
    273
    Units: Percentage of participants
        number (confidence interval 95%)
    66.7 (60.8 to 72.1)
    46.5 (40.5 to 52.6)
    Statistical analysis title
    C2 (G4)+C3 (G2) Vs C4591031 Sub study E
    Statistical analysis description
    Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (< median,>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.
    Comparison groups
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) v BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects included in analysis
    555
    Analysis specification
    Pre-specified
    Analysis type
    [43]
    Method
    Parameter type
    Adjusted Difference in Percentages
    Point estimate
    26.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.59
         upper limit
    33.95
    Notes
    [43] - Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-5%.

    Primary: Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 of BNT162b2 30mcg Cohort 2 (Group 2)/ Cohort 3 (Group 1) 18-55 Years of age and Cohort 2 (Group 4)/ Cohort 3 (Group 2) >55 Years of age– 1 Month After Vaccination in C4591044

    Close Top of page
    End point title
    Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 of BNT162b2 30mcg Cohort 2 (Group 2)/ Cohort 3 (Group 1) 18-55 Years of age and Cohort 2 (Group 4)/ Cohort 3 (Group 2) >55 Years of age– 1 Month After Vaccination in C4591044 [44]
    End point description
    Seroresponse: achieving >= 4-fold rise in NTs from baseline (before study vaccination). If baseline measurement was below LLOQ, postvaccination measure of >= 4*LLOQ was considered seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined in participants 18-55 years of age compared to participants >55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg 1 month after vaccination in study C4591044 in participants 18-55 years of age compared to participants >55 years of age is reported in statistical section. Endpoint was planned to be analysed in participants combined from C2 G2 + C3 G1 and C2 G4 + C3 G2. EIP was analysed with or without evidence of infection up to 1 month post study vaccination. "N"=participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 month after study vaccination
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Number of subjects analysed
    294
    282
    Units: Percentage of participants
        number (confidence interval 95%)
    61.2 (55.4 to 66.8)
    66.7 (60.8 to 72.1)
    Statistical analysis title
    C2(G2)+C3(G1) 18-55 Vs C2(G4)+C3(G2) >55:BNT30mcg
    Statistical analysis description
    Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-10%.
    Comparison groups
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) v C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg)
    Number of subjects included in analysis
    576
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Adjusted Difference in Percentages
    Point estimate
    -3.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.68
         upper limit
    3.63

    Primary: GMR of Omicron (BA.4/BA.5)– NTs of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg C2 G2/C3 G1 Combined for 18-55 Years Compared to BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg C2 G4/C3 G2 Combined for >55 Years– 1 Month After Vaccination in C4591044

    Close Top of page
    End point title
    GMR of Omicron (BA.4/BA.5)– NTs of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg C2 G2/C3 G1 Combined for 18-55 Years Compared to BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg C2 G4/C3 G2 Combined for >55 Years– 1 Month After Vaccination in C4591044 [45]
    End point description
    Model based GMT of OMI BA.4/BA.5 NTs induced by BNT Bivalent 30mcg groups of study C4591044 [NCT05472038] Cohort 2/3 combined in participants 18-55 years of age compared to participants >55 years of age are presented as descriptive data. GMTs and 2-sided 95% CIs were calculated by exponentiating LS means and corresponding CIs based on analysis of logarithmically transformed NT using linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ= 0.5*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT Bivalent vaccination in study C4591044 among participants 18-55 years of age compared to participants >55 years of age is reported in statistical section. Endpoint was planned to be analysed in participants combined from C2 G2 + C3 G1 and C2 G4 + C3 G2. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. "N"= participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 month after study vaccination
    Notes
    [45] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Number of subjects analysed
    282
    294
    Units: Titer
        geometric mean (confidence interval 95%)
    4344.4 (3850.2 to 4902.1)
    4254.2 (3779.6 to 4788.4)
    Statistical analysis title
    C2(G2)+C3(G1) 18-55 Vs C2(G4)+C3(G2) >55:BNT30mcg
    Statistical analysis description
    Noninferiority based on model-based GMR was declared if the lower limit of the 2-sided 95% CI for the model-based GMR is greater than 0.67.
    Comparison groups
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) v C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Number of subjects included in analysis
    576
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Model-Based GMR
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.83
         upper limit
    1.16

    Primary: Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline

    Close Top of page
    End point title
    Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline [46] [47]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This endpoint was planned per protocol to be analysed in participants from Cohort 2 and control arms of BNT162b2 Bivalent (WT/OMI BA.1) experienced participants 12-17 years of age, 18-55 years of age and >55 years of age from study C4591031 Substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Number of Participants Analysed" signifies participants evaluable for this endpoint and ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    At baseline (before study vaccination)
    Notes
    [46] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [47] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg) 18-55 Years (BNT162b2 Bivalent(WT/OMI BA.1)30mcg):C4591031 SSE 18-55 Years(BNT162b2 Bivalent[WT/OMI BA.1] 60mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60mcg):C4591031 SSE
    Number of subjects analysed
    105
    102
    98
    95
    102
    100
    100
    100
    100
    Units: Titer
    geometric mean (confidence interval 95%)
        OMI BA.4/BA.5(n=104,102,98,100,100,99,100,101,95)
    1105.8 (835.1 to 1464.3)
    607.0 (433.2 to 850.6)
    582.4 (397.6 to 853.1)
    338.3 (238.1 to 480.7)
    301.9 (215.6 to 422.8)
    151.5 (113.4 to 202.3)
    420.6 (312.7 to 565.6)
    225.4 (164.1 to 309.6)
    249.6 (180.5 to 345.2)
        OMI BA.1(n=105,102,96,100,98,100,97,102,95)
    1190.5 (921.8 to 1537.5)
    653.1 (466.3 to 914.8)
    581.2 (392.5 to 860.6)
    346.0 (240.0 to 498.9)
    365.1 (260.8 to 511.1)
    194.6 (142.4 to 266.0)
    492.4 (351.5 to 689.9)
    316.3 (215.9 to 463.4)
    285.6 (195.8 to 416.5)
        Reference(n=105,101,98,100,100,100,100,101,95)
    6863.3 (5587.8 to 8430.1)
    4287.4 (3245.6 to 5663.8)
    4324.8 (3099.0 to 6035.4)
    2349.0 (1693.4 to 3258.4)
    2643.1 (1990.8 to 3509.1)
    1338.4 (1056.9 to 1695.1)
    3933.2 (3058.0 to 5058.9)
    1985.7 (1510.1 to 2611.0)
    2509.3 (1906.8 to 3302.3)
    No statistical analyses for this end point

    Primary: Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month

    Close Top of page
    End point title
    Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month [48] [49]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This endpoint was planned to be analysed in participants from Cohort 2 and control arms of BNT162b2 experienced participants 12-17 years of age, 18-55 years of age and >55 years of age from study C4591031 substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Number of Participants Analysed" signifies participants evaluable for this endpoint and ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [48] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [49] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg) 18-55 Years (BNT162b2 Bivalent(WT/OMI BA.1)30mcg):C4591031 SSE 18-55 Years(BNT162b2 Bivalent[WT/OMI BA.1] 60mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60mcg):C4591031 SSE
    Number of subjects analysed
    105
    102
    99
    95
    102
    100
    100
    100
    100
    Units: Titer
    geometric mean (confidence interval 95%)
        OMI BA.4/BA.5(n=105,102,99,100,100,100,100,102,95)
    8212.8 (6807.3 to 9908.7)
    5454.2 (4292.2 to 6930.8)
    5472.8 (3930.9 to 7619.6)
    2839.0 (2150.0 to 3748.8)
    3019.8 (2327.5 to 3918.0)
    1072.0 (816.1 to 1408.1)
    2525.2 (1970.5 to 3236.0)
    943.4 (733.4 to 1213.6)
    1520.9 (1196.0 to 1934.0)
        OMI BA.1(n=105,101,99,100,99,100,100,102,95)
    6687.6 (5617.0 to 7962.3)
    4112.4 (3263.6 to 5181.9)
    4264.0 (3247.9 to 5597.9)
    2407.2 (1884.9 to 3074.2)
    2656.1 (2089.6 to 3376.3)
    1819.0 (1401.6 to 2360.6)
    3143.8 (2486.9 to 3974.1)
    1617.7 (1274.7 to 2053.0)
    1936.9 (1489.4 to 2518.8)
        Reference(n=105,102,99,99,100,100,99,102,95)
    23641.3 (20473.1 to 27299.8)
    18614.7 (15754.1 to 21994.7)
    22982.3 (18524.3 to 28513.3)
    11919.3 (9839.1 to 14439.3)
    12103.8 (9992.0 to 14662.0)
    6913.9 (5690.4 to 8400.5)
    14685.8 (12301.1 to 17532.8)
    7128.6 (5954.4 to 8534.3)
    11106.5 (8956.8 to 13772.2)
    No statistical analyses for this end point

    Primary: Cohort 2: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination

    Close Top of page
    End point title
    Cohort 2: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination [50] [51]
    End point description
    GMFR from before the study vaccination to 1 month after the study vaccination for each strain-specific neutralising titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. This endpoint was planned to be analysed in participants from Cohort 2 and control arms of BNT162b2 experienced participants 12-17 years of age, 18-55 years of age and >55 years of age from study C4591031 substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Number of Participants Analysed" signifies participants evaluable for this endpoint and ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    From before the study vaccination to 1 month after the study vaccination
    Notes
    [50] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [51] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg) 18-55 Years (BNT162b2 Bivalent(WT/OMI BA.1)30mcg):C4591031 SSE 18-55 Years(BNT162b2 Bivalent[WT/OMI BA.1] 60mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60mcg):C4591031 SSE
    Number of subjects analysed
    105
    102
    98
    95
    102
    100
    100
    100
    100
    Units: Fold rise
    geometric mean (confidence interval 95%)
        OMI BA.4/BA.5(n=104,102,98,100,100,99,100,101,95)
    7.6 (6.0 to 9.6)
    9.0 (6.9 to 11.8)
    9.3 (6.8 to 12.8)
    8.4 (6.3 to 11.1)
    10.0 (7.5 to 13.3)
    7.1 (5.7 to 8.9)
    6.0 (4.7 to 7.7)
    4.2 (3.4 to 5.2)
    6.1 (4.7 to 7.9)
        OMI BA.1(n=105,101,96,100,97,100,97,102,95)
    5.6 (4.6 to 6.9)
    6.3 (4.9 to 8.2)
    7.3 (5.4 to 9.7)
    7.0 (5.3 to 9.1)
    7.3 (5.6 to 9.5)
    9.3 (7.3 to 12.0)
    6.4 (4.9 to 8.3)
    5.1 (3.9 to 6.6)
    6.8 (5.1 to 9.1)
        Reference(n=105,101,98,99,100,100,99,101,95)
    3.4 (2.9 to 4.1)
    4.3 (3.4 to 5.5)
    5.4 (4.0 to 7.1)
    5.1 (3.9 to 6.6)
    4.6 (3.7 to 5.8)
    5.2 (4.3 to 6.3)
    3.7 (3.0 to 4.6)
    3.6 (2.9 to 4.4)
    4.4 (3.5 to 5.6)
    No statistical analyses for this end point

    Primary: Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain– NTs at 1 Month After Study Vaccination

    Close Top of page
    End point title
    Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain– NTs at 1 Month After Study Vaccination [52] [53]
    End point description
    Seroresponse: achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 and 60 mcg in Study C4591044 [NCT05472038] Cohort 2 and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E among participants 12-17 years of age, 18-55 and >55 years of age are presented as descriptive data. This endpoint was planned to be analysed in participants from Cohort 2 and control arms of BNT162b2 experienced participants 18-55 years of age and >55 years of age from study C4591031 substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Number of Participants Analysed" signifies participants evaluable for this endpoint and ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [52] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [53] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2 reporting groups only.
    End point values
    C2 G1:12-17 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2G3: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60mcg) C2 G5: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 60 mcg) C2G2: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg) C2 G4: >55 Years (BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg) 18-55 Years (BNT162b2 Bivalent(WT/OMI BA.1)30mcg):C4591031 SSE 18-55 Years(BNT162b2 Bivalent[WT/OMI BA.1] 60mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30mcg):C4591031 SSE >55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60mcg):C4591031 SSE
    Number of subjects analysed
    105
    102
    98
    95
    102
    100
    100
    100
    100
    Units: Percentage of participants
    number (confidence interval 95%)
        OMI BA.4/BA.5(n=104,102,98,100,100,99,100,101,95)
    66.3 (56.4 to 75.3)
    66.7 (56.6 to 75.7)
    63.3 (52.9 to 72.8)
    64.2 (53.7 to 73.8)
    71.3 (61.4 to 79.9)
    62.0 (51.7 to 71.5)
    59.0 (48.7 to 68.7)
    37.4 (27.9 to 47.7)
    53.0 (42.8 to 63.1)
        OMI BA.1(n=105,101,96,100,97,100,97,102,95)
    63.8 (53.9 to 73.0)
    60.4 (50.2 to 70.0)
    65.6 (55.2 to 75.0)
    54.7 (44.2 to 65.0)
    63.7 (53.6 to 73.0)
    75.0 (65.3 to 83.1)
    56.7 (46.3 to 66.7)
    52.0 (41.8 to 62.1)
    58.8 (48.3 to 68.7)
        Reference(n=105,101,98,99,100,100,99,101,95)
    41.0 (31.5 to 51.0)
    51.5 (41.3 to 61.6)
    55.1 (44.7 to 65.2)
    49.5 (39.1 to 59.9)
    50.5 (40.4 to 60.0)
    59.6 (49.3 to 69.3)
    41.0 (31.3 to 51.3)
    41.0 (31.3 to 51.3)
    44.4 (34.5 to 54.8)
    No statistical analyses for this end point

    Primary: Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination [54] [55]
    End point description
    Local reactions were recorded by participants in e-diary. Local reactions: redness, swelling, pain at injection site. Redness and swelling were graded as mild: > 2.0-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, grade 4: necrosis or exfoliative dermatitis (redness), necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: ER visit or hospitalisation. Grade 4 reactions (potentially life threatening) were classified by investigator/medically qualified person. Local reactions reported as AEs in CRF within 7 days after study vaccination were reported. Safety population: all participants receiving study intervention and obtaining informed consent. Here, "Number of Participants Analysed"= participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [54] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [55] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    62
    61
    60
    60
    63
    Units: Percentage of participants
    number (confidence interval 95%)
        Redness: Any
    4.8 (1.0 to 13.5)
    3.3 (0.4 to 11.3)
    5.0 (1.0 to 13.9)
    1.7 (0.0 to 8.9)
    1.6 (0.0 to 8.5)
        Redness: Mild
    3.2 (0.4 to 11.2)
    3.3 (0.4 to 11.3)
    5.0 (1.0 to 13.9)
    1.7 (0.0 to 8.9)
    1.6 (0.0 to 8.5)
        Redness: Moderate
    1.6 (0.0 to 8.7)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Redness: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Redness: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Swelling: Any
    1.6 (0.0 to 8.7)
    3.3 (0.4 to 11.3)
    6.7 (1.8 to 16.2)
    3.3 (0.4 to 11.5)
    3.2 (0.4 to 11.0)
        Swelling: Mild
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    6.7 (1.8 to 16.2)
    3.3 (0.4 to 11.5)
    3.2 (0.4 to 11.0)
        Swelling: Moderate
    1.6 (0.0 to 8.7)
    3.3 (0.4 to 11.3)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Swelling: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Swelling: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Pain at injection site: Any
    85.5 (74.2 to 93.1)
    88.5 (77.8 to 95.3)
    76.7 (64.0 to 86.6)
    76.7 (64.0 to 86.6)
    84.1 (72.7 to 92.1)
        Pain at injection site: Mild
    64.5 (51.3 to 76.3)
    65.6 (52.3 to 77.3)
    68.3 (55.0 to 79.7)
    61.7 (48.2 to 73.9)
    68.3 (55.3 to 79.4)
        Pain at injection site: Moderate
    21.0 (11.7 to 33.2)
    21.3 (11.9 to 33.7)
    8.3 (2.8 to 18.4)
    15.0 (7.1 to 26.6)
    15.9 (7.9 to 27.3)
        Pain at injection site: Severe
    0 (0.0 to 5.8)
    1.6 (0.0 to 8.8)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Pain at injection site: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
    No statistical analyses for this end point

    Primary: Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination

    Close Top of page
    End point title
    Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination [56] [57]
    End point description
    Systemic events were recorded by participants in e-diary. Fever: oral temperature >= 38 deg C and categorised as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C, >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain= mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity. Vomiting= mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea= mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Except fever, Grade 4= ER visit or hospitalisation. Grade 4 events were classified by investigator or medically qualified person. Systemic events reported as AEs in CRF within 7 days after vaccination are included. Safety population= participants receiving study intervention and obtaining informed consent. "Number of Participants Analysed"= participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after study vaccination
    Notes
    [56] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [57] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    62
    61
    60
    60
    63
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Any
    6.5 (1.8 to 15.7)
    6.6 (1.8 to 15.9)
    10.0 (3.8 to 20.5)
    5.0 (1.0 to 13.9)
    9.5 (3.6 to 19.6)
        Fever: >=38.0 deg C to 38.4 deg C
    3.2 (0.4 to 11.2)
    6.6 (1.8 to 15.9)
    5.0 (1.0 to 13.9)
    5.0 (1.0 to 13.9)
    4.8 (1.0 to 13.3)
        Fever: >38.4 deg C to 38.9 deg C
    3.2 (0.4 to 11.2)
    0 (0.0 to 5.9)
    3.3 (0.4 to 11.5)
    0 (0.0 to 6.0)
    1.6 (0.0 to 8.5)
        Fever: >38.9 deg C to 40.0 deg C
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    1.7 (0.0 to 8.9)
    0 (0.0 to 6.0)
    3.2 (0.4 to 11.0)
        Fever: >40.0 deg C
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Fatigue: Any
    61.3 (48.1 to 73.4)
    63.9 (50.6 to 75.8)
    73.3 (60.3 to 83.9)
    66.7 (53.3 to 78.3)
    54.0 (40.9 to 66.6)
        Fatigue: Mild
    25.8 (15.5 to 38.5)
    29.5 (18.5 to 42.6)
    38.3 (26.1 to 51.8)
    35.0 (23.1 to 48.4)
    17.5 (9.1 to 29.1)
        Fatigue: Moderate
    35.5 (23.7 to 48.7)
    34.4 (22.7 to 47.7)
    33.3 (21.7 to 46.7)
    30.0 (18.8 to 43.2)
    34.9 (23.3 to 48.0)
        Fatigue: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    1.7 (0.0 to 8.9)
    1.7 (0.0 to 8.9)
    1.6 (0.0 to 8.5)
        Fatigue: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Headache: Any
    59.7 (46.4 to 71.9)
    36.1 (24.2 to 49.4)
    41.7 (29.1 to 55.1)
    46.7 (33.7 to 60.0)
    39.7 (27.6 to 52.8)
        Headache: Mild
    38.7 (26.6 to 51.9)
    16.4 (8.2 to 28.1)
    23.3 (13.4 to 36.0)
    23.3 (13.4 to 36.0)
    22.2 (12.7 to 34.5)
        Headache: Moderate
    17.7 (9.2 to 29.5)
    19.7 (10.6 to 31.8)
    18.3 (9.5 to 30.4)
    21.7 (12.1 to 34.2)
    17.5 (9.1 to 29.1)
        Headache: Severe
    3.2 (0.4 to 11.2)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    1.7 (0.0 to 8.9)
    0 (0.0 to 5.7)
        Headache: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Chills: Any
    22.6 (12.9 to 35.0)
    18.0 (9.4 to 30.0)
    28.3 (17.5 to 41.4)
    13.3 (5.9 to 24.6)
    19.0 (10.2 to 30.9)
        Chills: Mild
    11.3 (4.7 to 21.9)
    11.5 (4.7 to 22.2)
    18.3 (9.5 to 30.4)
    8.3 (2.8 to 18.4)
    12.7 (5.6 to 23.5)
        Chills: Moderate
    11.3 (4.7 to 21.9)
    6.6 (1.8 to 15.9)
    10.0 (3.8 to 20.5)
    5.0 (1.0 to 13.9)
    6.3 (1.8 to 15.5)
        Chills: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Chills: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Vomiting: Any
    0 (0.0 to 5.8)
    1.6 (0.0 to 8.8)
    3.3 (0.4 to 11.5)
    5.0 (1.0 to 13.9)
    1.6 (0.0 to 8.5)
        Vomiting: Mild
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    3.3 (0.4 to 11.5)
    1.7 (0.0 to 8.9)
    1.6 (0.0 to 8.5)
        Vomiting: Moderate
    0 (0.0 to 5.8)
    1.6 (0.0 to 8.8)
    0 (0.0 to 6.0)
    3.3 (0.4 to 11.5)
    0 (0.0 to 5.7)
        Vomiting: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Vomiting: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Diarrhea: Any
    12.9 (5.7 to 23.9)
    6.6 (1.8 to 15.9)
    16.7 (8.3 to 28.5)
    16.7 (8.3 to 28.5)
    12.7 (5.6 to 23.5)
        Diarrhea: Mild
    9.7 (3.6 to 19.9)
    6.6 (1.8 to 15.9)
    15.0 (7.1 to 26.6)
    13.3 (5.9 to 24.6)
    11.1 (4.6 to 21.6)
        Diarrhea: Moderate
    3.2 (0.4 to 11.2)
    0 (0.0 to 5.9)
    1.7 (0.0 to 8.9)
    3.3 (0.4 to 11.5)
    1.6 (0.0 to 8.5)
        Diarrhea: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        Diarrhea: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        New or worsened muscle pain: Any
    25.8 (15.5 to 38.5)
    21.3 (11.9 to 33.7)
    45.0 (32.1 to 58.4)
    30.0 (18.8 to 43.2)
    27.0 (16.6 to 39.7)
        New or worsened muscle pain: Mild
    19.4 (10.4 to 31.4)
    8.2 (2.7 to 18.1)
    23.3 (13.4 to 36.0)
    11.7 (4.8 to 22.6)
    12.7 (5.6 to 23.5)
        New or worsened muscle pain: Moderate
    6.5 (1.8 to 15.7)
    11.5 (4.7 to 22.2)
    21.7 (12.1 to 34.2)
    18.3 (9.5 to 30.4)
    14.3 (6.7 to 25.4)
        New or worsened muscle pain: Severe
    0 (0.0 to 5.8)
    1.6 (0.0 to 8.8)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        New or worsened joint pain: Any
    14.5 (6.9 to 25.8)
    14.8 (7.0 to 26.2)
    5.0 (1.0 to 13.9)
    13.3 (5.9 to 24.6)
    17.5 (9.1 to 29.1)
        New or worsened joint pain: Mild
    9.7 (3.6 to 19.9)
    6.6 (1.8 to 15.9)
    0 (0.0 to 6.0)
    3.3 (0.4 to 11.5)
    7.9 (2.6 to 17.6)
        New or worsened joint pain: Moderate
    4.8 (1.0 to 13.5)
    8.2 (2.7 to 18.1)
    5.0 (1.0 to 13.9)
    10.0 (3.8 to 20.5)
    9.5 (3.6 to 19.6)
        New or worsened joint pain: Severe
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
        New or worsened joint pain: Grade 4
    0 (0.0 to 5.8)
    0 (0.0 to 5.9)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
    No statistical analyses for this end point

    Primary: Cohort 4: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination

    Close Top of page
    End point title
    Cohort 4: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination [58] [59]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
    End point type
    Primary
    End point timeframe
    From study vaccination through 6 months after study vaccination
    Notes
    [58] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [59] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    62
    62
    60
    60
    63
    Units: Percentage of participants
        number (confidence interval 95%)
    1.6 (0.0 to 8.7)
    0 (0.0 to 5.8)
    0 (0.0 to 6.0)
    0 (0.0 to 6.0)
    0 (0.0 to 5.7)
    No statistical analyses for this end point

    Primary: Cohort 4: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination

    Close Top of page
    End point title
    Cohort 4: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination [60] [61]
    End point description
    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
    End point type
    Primary
    End point timeframe
    From study vaccination through 1 month after study vaccination
    Notes
    [60] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [61] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    62
    62
    60
    60
    63
    Units: Percentage of participants
        number (confidence interval 95%)
    8.1 (2.7 to 17.8)
    9.7 (3.6 to 19.9)
    1.7 (0.0 to 8.9)
    1.7 (0.0 to 8.9)
    1.6 (0.0 to 8.5)
    No statistical analyses for this end point

    Primary: Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection [62] [63]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Evaluable immunogenicity population included all eligible randomised/assigned participants who received the study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [62] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [63] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    61
    61
    57
    56
    61
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.4/BA.5 (n=61,61,57,56,61)
    4850.5 (3677.1 to 6398.3)
    4854.3 (3713.9 to 6344.9)
    4944.6 (3620.3 to 6753.1)
    5180.6 (3724.6 to 7205.8)
    5455.6 (4214.2 to 7062.8)
        Reference strain (n=61,61,57,56,61)
    10455.0 (8150.7 to 13410.8)
    11360.0 (9408.3 to 13716.6)
    10840.2 (8475.3 to 13865.0)
    12303.8 (9728.6 to 15560.5)
    11164.3 (8729.0 to 14279.0)
    No statistical analyses for this end point

    Primary: Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at Baseline

    Close Top of page
    End point title
    Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at Baseline [64] [65]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Evaluable immunogenicity population included all eligible randomised/assigned participants who received the study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    At baseline (before study vaccination)
    Notes
    [64] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [65] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    61
    61
    57
    56
    61
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.4/BA.5 (n= 61,61,57,56,61)
    1332.5 (909.2 to 1953.0)
    1313.6 (922.6 to 1870.2)
    1352.0 (876.0 to 2086.8)
    1320.1 (869.8 to 2003.6)
    1203.9 (796.5 to 1819.6)
        Reference strain (n= 61,61,57,56,61)
    3445.5 (2465.4 to 4815.3)
    4907.1 (3753.0 to 6416.1)
    4613.6 (3474.3 to 6126.4)
    4395.7 (3244.1 to 5956.3)
    4318.6 (3196.1 to 5835.2)
    No statistical analyses for this end point

    Primary: Cohort 4: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 4: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection [66] [67]
    End point description
    GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralising titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5*LLOQ in analysis. EIP included all eligible randomised/assigned participants who received study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, and had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after study vaccination
    Notes
    [66] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [67] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    61
    61
    57
    56
    61
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Omicron BA.4/BA.5 (n=61,61,57,56,61)
    3.6 (2.7 to 4.8)
    3.7 (2.7 to 5.0)
    3.7 (2.8 to 4.7)
    3.9 (2.9 to 5.3)
    4.5 (3.3 to 6.2)
        Reference strain (n=61,61,57,56,61)
    3.0 (2.3 to 4.0)
    2.3 (1.8 to 3.0)
    2.3 (1.9 to 2.8)
    2.8 (2.1 to 3.7)
    2.6 (2.1 to 3.2)
    No statistical analyses for this end point

    Primary: Cohort 4: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection

    Close Top of page
    End point title
    Cohort 4: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection [68] [69]
    End point description
    Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5, XBB.1.5 and reference strain NTs at 1 month after study vaccination are presented as descriptive data. EIP included all eligible randomised/assigned participants who received study intervention to which they were randomised/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, and had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''n’’ signifies participants evaluable for specified rows.
    End point type
    Primary
    End point timeframe
    1 month after the study vaccination
    Notes
    [68] - 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: Per protocol, only descriptive data was planned to be analysed for this endpoint.
    [69] - 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: Per protocol, this analysis was planned to be analysed in Cohort 4 reporting groups only.
    End point values
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Number of subjects analysed
    61
    61
    57
    56
    61
    Units: Percentage of participants
    number (confidence interval 95%)
        Omicron BA.4/BA.5 (n=61,61,57,56,61)
    42.6 (30.0 to 55.9)
    41.0 (28.6 to 54.3)
    42.1 (29.1 to 55.9)
    39.3 (26.5 to 53.2)
    44.3 (31.5 to 57.6)
        Reference strain (n=61,61,57,56,61)
    37.7 (25.6 to 51.0)
    27.9 (17.1 to 40.8)
    22.8 (12.7 to 35.8)
    26.8 (15.8 to 40.3)
    29.5 (18.5 to 42.6)
    No statistical analyses for this end point

    Secondary: GMR of the Reference-Strain– NTs of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30mcg in C4591031 >55 Years of age– 1 Month After Vaccination

    Close Top of page
    End point title
    GMR of the Reference-Strain– NTs of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30mcg in C4591031 >55 Years of age– 1 Month After Vaccination [70]
    End point description
    Model based GMT of reference strain NTs induced by BNT Bivalent 30mcg groups of study C4591044 [NCT05472038] Cohort 2/3 combined; BNT 30mcg of study C4591031 [NCT04955626] Substudy E in participants >55 years presented as descriptive data. GMT and 2-sided 95% CI calculated by exponentiating LS means and corresponding CI based on analysis of logarithmically transformed NT using linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ=0.5*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT Bivalent vaccination in study C4591044 to 1 month after BNT vaccination in study C4591031 in participants >55 years reported in statistical section. Endpoint was planned per protocol to analyse in participants from C2 G4+C3 G2 and BNT experienced participants >55 years from study C4591031 Substudy E (control arm). Analysis= EIP with/without evidence of infection up to 1 month post vaccination. "N"= participants evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    1 month after study vaccination
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects analysed
    284
    287
    Units: Titer
        geometric mean (confidence interval 95%)
    15361.6 (14082.9 to 16756.5)
    11117.2 (10196.4 to 12121.1)
    Statistical analysis title
    C2 (G2)+C3 (G1) Vs C4591031 Sub study E
    Statistical analysis description
    Noninferiority based on model-based GMR was declared if the lower limit of the 2-sided 95% CI for the model-based GMR is greater than 0.67.
    Comparison groups
    C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) v BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Model-Based GMR
    Point estimate
    1.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.22
         upper limit
    1.56

    Secondary: Cohort 2/Group 2 + Cohort 3/Group 1 Combined and Cohort 2/Group 4 + Cohort 3/Group 2 Combined: GMT of SARS-CoV-2 Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination

    Close Top of page
    End point title
    Cohort 2/Group 2 + Cohort 3/Group 1 Combined and Cohort 2/Group 4 + Cohort 3/Group 2 Combined: GMT of SARS-CoV-2 Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination [71]
    End point description
    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This endpoint was planned per protocol to be analysed in participants from Cohort 2 Group 2 + Cohort 3 Group 1, Cohort 2 Group 4 + Cohort 3 Group 2 and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 Substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Number of Participants Analysed": participants evaluable for this endpoint and ''n’’ signifies participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    At baseline and 1 month after study vaccination
    Notes
    [71] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects analysed
    297
    286
    289
    Units: Titer
    geometric mean (confidence interval 95%)
        Omicron BA.4/BA.5 at baseline(n=294,284,278)
    569.6 (471.4 to 688.2)
    458.2 (365.2 to 574.8)
    205.4 (170.3 to 247.7)
        Omicron BA.4/BA.5 at 1 Month(n=297,284,282)
    4455.9 (3851.7 to 5154.8)
    4158.1 (3554.8 to 4863.8)
    938.9 (802.3 to 1098.8)
        Reference strain at baseline(n=296,284,287)
    4017.3 (3430.7 to 4704.1)
    3690.6 (3082.2 to 4419.0)
    2699.9 (2291.7 to 3180.9)
        Reference strain at 1 Month(n=296,286,289)
    16323.3 (14686.5 to 18142.6)
    16250.1 (14499.2 to 18212.4)
    10415.5 (9366.7 to 11581.8)
    No statistical analyses for this end point

    Secondary: Cohort 2/Group 2 + Cohort 3/Group 1 Combined and Cohort 2/Group 4 + Cohort 3/Group 2 Combined: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination

    Close Top of page
    End point title
    Cohort 2/Group 2 + Cohort 3/Group 1 Combined and Cohort 2/Group 4 + Cohort 3/Group 2 Combined: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs From Before the Study Vaccination to 1 Month After the Study Vaccination [72]
    End point description
    GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFR from before the study vaccination to 1 month after study vaccination for Omicron BA.4/BA.5 and reference strain neutralising titer was reported in this endpoint. This endpoint was planned per protocol to be analysed in participants from Cohort 2 Group 2 + Cohort 3 Group 1, Cohort 2 Group 4 + Cohort 3 Group 2 and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 Substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Number of Participants Analysed" signifies participants evaluable for this endpoint and ''n’’ signifies participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    From before the study vaccination to 1 month after study vaccination
    Notes
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects analysed
    295
    284
    287
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Omicron BA.4/BA.5 (n=294,282,273)
    7.8 (6.7 to 9.2)
    8.9 (7.5 to 10.6)
    4.6 (4.0 to 5.2)
        Reference strain (n=295,284,287)
    4.1 (3.6 to 4.6)
    4.4 (3.8 to 5.1)
    3.9 (3.4 to 4.4)
    No statistical analyses for this end point

    Secondary: Cohort 2/Group 2 + Cohort 3/Group 1 Combined and Cohort 2/Group 4 + Cohort 3/Group 2 Combined: Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs at 1 Month After the Study Vaccination

    Close Top of page
    End point title
    Cohort 2/Group 2 + Cohort 3/Group 1 Combined and Cohort 2/Group 4 + Cohort 3/Group 2 Combined: Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain– NTs at 1 Month After the Study Vaccination [73]
    End point description
    Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before study vaccination). If baseline measurement was below LLOQ, postvaccination measure of >= 4*LLOQ was considered seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E among participants >55 years of age are presented as descriptive data. This endpoint was planned per protocol to be analysed in participants from Cohort 2 Group 2 + Cohort 3 Group 1, Cohort 2 Group 4 + Cohort 3 Group 2 and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 Substudy E. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. "Number of Participants Analysed" signifies participants evaluable for this endpoint and ''n'' signifies participants evaluable for the specified rows.
    End point type
    Secondary
    End point timeframe
    1 month after the study vaccination
    Notes
    [73] - 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: Per protocol, this analysis was planned to be analysed in Cohort 2+3 reporting groups only.
    End point values
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C2G4+C3G2:>55 Years(BNT162b2 Bivalent [WT/OMI BA.4/BA.5]30mcg) BNT162b2 30 mcg: C4591031 Substudy E
    Number of subjects analysed
    295
    284
    287
    Units: Percentage of participants
    number (confidence interval 95%)
        Omicron BA.4/BA.5(n=294,282,273)
    61.2 (55.4 to 66.8)
    66.7 (60.8 to 72.1)
    46.5 (40.5 to 52.6)
        Reference strain(n=295,284,287)
    44.1 (38.3 to 49.9)
    45.8 (39.9 to 51.8)
    48.1 (42.2 to 54.0)
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
    Adverse event reporting additional description
    Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorised as serious in 1 and non-serious in other, or participant may experience both SAE and non-SAE. Safety population. Per analysis planned, data is summarised and combined for C2/C3 30mcg groups per age category. MedDRA for C1/C4: v27.0; for C2/C3: v26.0.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    C 2 G 1: 12-17 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg)
    Reporting group description
    Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C 2 G 3: 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C2G4+C3G2:>55 Years (BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged more than (>) 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C 2 G 5: >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg)
    Reporting group description
    Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b6 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b2 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b5 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b7 Bivalent (Original/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Reporting group title
    C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Reporting group description
    Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).

    Serious adverse events
    C 2 G 1: 12-17 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg) C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C 2 G 3: 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg) C2G4+C3G2:>55 Years (BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C 2 G 5: >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg) Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg) C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 313 (0.64%)
    1 / 110 (0.91%)
    10 / 306 (3.27%)
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 60 (0.00%)
    2 / 102 (1.96%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Leukaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Testicular germ cell cancer
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    1 / 110 (0.91%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Prostate cancer
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 313 (0.32%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Left ventricular failure
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Blood and lymphatic system disorders
    Normocytic anaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    1 / 102 (0.98%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Small intestinal obstruction
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    1 / 102 (0.98%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    1 / 102 (0.98%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Acute kidney injury
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 313 (0.32%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Post procedural infection
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Gastroenteritis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Enterocolitis infectious
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Hypokalaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    C 2 G 1: 12-17 Years (BNT162b2 [WT/OMI BA.4/BA.5] 30 mcg) C2G2+C3G1:18-55Years(BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C 2 G 3: 18-55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg) C2G4+C3G2:>55 Years (BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg) C 2 G 5: >55 Years (BNT162b2 [WT/OMI BA.4/BA.5] 60 mcg) Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg) C4:18-55 Years(BNT162b6 Bivalent[Original/OMI BA.4/BA.5]30mcg) Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg) C4:18-55 Years(BNT162b2 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b5 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4:18-55 Years(BNT162b7 Bivalent[Original/OMI BA.4/BA.5]30mcg) C4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/BA.5] 30 mcg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    96 / 107 (89.72%)
    269 / 313 (85.94%)
    106 / 110 (96.36%)
    210 / 306 (68.63%)
    82 / 102 (80.39%)
    97 / 104 (93.27%)
    52 / 60 (86.67%)
    91 / 102 (89.22%)
    55 / 62 (88.71%)
    56 / 62 (90.32%)
    53 / 60 (88.33%)
    56 / 63 (88.89%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 107 (50.47%)
    144 / 313 (46.01%)
    50 / 110 (45.45%)
    92 / 306 (30.07%)
    36 / 102 (35.29%)
    55 / 104 (52.88%)
    25 / 60 (41.67%)
    47 / 102 (46.08%)
    37 / 62 (59.68%)
    22 / 62 (35.48%)
    28 / 60 (46.67%)
    25 / 63 (39.68%)
         occurrences all number
    54
    144
    50
    92
    36
    55
    25
    47
    37
    22
    28
    25
    Bell's palsy
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 107 (0.00%)
    6 / 313 (1.92%)
    1 / 110 (0.91%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    6
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 107 (2.80%)
    2 / 313 (0.64%)
    1 / 110 (0.91%)
    1 / 306 (0.33%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 60 (1.67%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    1 / 62 (1.61%)
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    3
    2
    1
    1
    0
    0
    1
    0
    1
    1
    1
    0
    Chills (CHILLS)
    alternative assessment type: Systematic
         subjects affected / exposed
    25 / 107 (23.36%)
    68 / 313 (21.73%)
    30 / 110 (27.27%)
    36 / 306 (11.76%)
    23 / 102 (22.55%)
    22 / 104 (21.15%)
    17 / 60 (28.33%)
    20 / 102 (19.61%)
    14 / 62 (22.58%)
    11 / 62 (17.74%)
    8 / 60 (13.33%)
    12 / 63 (19.05%)
         occurrences all number
    25
    68
    30
    36
    23
    22
    17
    20
    14
    11
    8
    12
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    72 / 107 (67.29%)
    189 / 313 (60.38%)
    76 / 110 (69.09%)
    115 / 306 (37.58%)
    54 / 102 (52.94%)
    76 / 104 (73.08%)
    44 / 60 (73.33%)
    64 / 102 (62.75%)
    38 / 62 (61.29%)
    39 / 62 (62.90%)
    39 / 60 (65.00%)
    34 / 63 (53.97%)
         occurrences all number
    72
    189
    76
    115
    54
    76
    44
    64
    38
    39
    39
    34
    Injection site erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 107 (5.61%)
    20 / 313 (6.39%)
    12 / 110 (10.91%)
    11 / 306 (3.59%)
    7 / 102 (6.86%)
    6 / 104 (5.77%)
    3 / 60 (5.00%)
    6 / 102 (5.88%)
    3 / 62 (4.84%)
    2 / 62 (3.23%)
    1 / 60 (1.67%)
    1 / 63 (1.59%)
         occurrences all number
    6
    20
    12
    11
    7
    6
    3
    6
    3
    2
    1
    1
    Injection site pain (PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    75 / 107 (70.09%)
    235 / 313 (75.08%)
    103 / 110 (93.64%)
    171 / 306 (55.88%)
    71 / 102 (69.61%)
    86 / 104 (82.69%)
    45 / 60 (75.00%)
    83 / 102 (81.37%)
    52 / 62 (83.87%)
    54 / 62 (87.10%)
    46 / 60 (76.67%)
    52 / 63 (82.54%)
         occurrences all number
    75
    235
    103
    171
    71
    86
    45
    83
    52
    54
    46
    52
    Injection site pain
         subjects affected / exposed
    2 / 107 (1.87%)
    2 / 313 (0.64%)
    0 / 110 (0.00%)
    1 / 306 (0.33%)
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    2 / 60 (3.33%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    3 / 62 (4.84%)
    1 / 60 (1.67%)
    3 / 63 (4.76%)
         occurrences all number
    2
    2
    0
    1
    1
    0
    2
    0
    1
    3
    1
    3
    Injection site swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 107 (7.48%)
    22 / 313 (7.03%)
    17 / 110 (15.45%)
    8 / 306 (2.61%)
    9 / 102 (8.82%)
    11 / 104 (10.58%)
    4 / 60 (6.67%)
    11 / 102 (10.78%)
    1 / 62 (1.61%)
    2 / 62 (3.23%)
    2 / 60 (3.33%)
    2 / 63 (3.17%)
         occurrences all number
    8
    22
    17
    8
    9
    11
    4
    11
    1
    2
    2
    2
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 107 (9.35%)
    15 / 313 (4.79%)
    13 / 110 (11.82%)
    13 / 306 (4.25%)
    14 / 102 (13.73%)
    2 / 104 (1.92%)
    6 / 60 (10.00%)
    6 / 102 (5.88%)
    4 / 62 (6.45%)
    4 / 62 (6.45%)
    3 / 60 (5.00%)
    6 / 63 (9.52%)
         occurrences all number
    10
    15
    13
    13
    14
    2
    6
    6
    4
    4
    3
    6
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea (DIARRHEA)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 107 (6.54%)
    33 / 313 (10.54%)
    14 / 110 (12.73%)
    28 / 306 (9.15%)
    7 / 102 (6.86%)
    15 / 104 (14.42%)
    10 / 60 (16.67%)
    20 / 102 (19.61%)
    8 / 62 (12.90%)
    4 / 62 (6.45%)
    10 / 60 (16.67%)
    8 / 63 (12.70%)
         occurrences all number
    7
    33
    14
    28
    7
    15
    10
    20
    8
    4
    10
    8
    Vomiting (VOMITING)
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 107 (2.80%)
    6 / 313 (1.92%)
    2 / 110 (1.82%)
    2 / 306 (0.65%)
    3 / 102 (2.94%)
    1 / 104 (0.96%)
    2 / 60 (3.33%)
    2 / 102 (1.96%)
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    3 / 60 (5.00%)
    1 / 63 (1.59%)
         occurrences all number
    3
    6
    2
    2
    3
    1
    2
    2
    0
    1
    3
    1
    Vomiting
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia (MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 107 (26.17%)
    94 / 313 (30.03%)
    46 / 110 (41.82%)
    54 / 306 (17.65%)
    23 / 102 (22.55%)
    37 / 104 (35.58%)
    27 / 60 (45.00%)
    39 / 102 (38.24%)
    16 / 62 (25.81%)
    13 / 62 (20.97%)
    17 / 60 (28.33%)
    17 / 63 (26.98%)
         occurrences all number
    28
    94
    46
    54
    23
    37
    27
    39
    16
    13
    17
    17
    Myalgia
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 60 (1.67%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Arthralgia (JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 107 (12.15%)
    46 / 313 (14.70%)
    27 / 110 (24.55%)
    36 / 306 (11.76%)
    15 / 102 (14.71%)
    19 / 104 (18.27%)
    3 / 60 (5.00%)
    18 / 102 (17.65%)
    9 / 62 (14.52%)
    9 / 62 (14.52%)
    8 / 60 (13.33%)
    11 / 63 (17.46%)
         occurrences all number
    13
    46
    27
    36
    15
    19
    3
    18
    9
    9
    8
    11
    Back pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 313 (0.32%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Joint abscess
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    3 / 104 (2.88%)
    0 / 60 (0.00%)
    4 / 102 (3.92%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    4
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 60 (1.67%)
    0 / 102 (0.00%)
    0 / 62 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 313 (0.00%)
    0 / 110 (0.00%)
    0 / 306 (0.00%)
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 60 (0.00%)
    0 / 102 (0.00%)
    1 / 62 (1.61%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2022
    Inclusion of a second cohort to describe the immune response to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at 30 mcg in individuals >=12 years of age and at 60 mcg in adults >=18 years of age. Added corresponding objectives, estimands, and endpoints and details in the statistical methods sections. Study intervention details and background information supporting inclusion of this cohort were added. Inclusion of prospective capture of confirmed COVID-19 cases for both Cohorts 1 and 2 with active COVID-19 surveillance and convalescent visits.
    24 Aug 2022
    Inclusion of a third cohort to allow for a sufficiently powered evaluation of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg as a second booster dose in BNT162b2-experienced participants >=18 years of age. Added corresponding objectives, estimands, and endpoints and details in the statistical methods sections. Study intervention details and background information supporting inclusion of this cohort were added.
    26 May 2023
    Inclusion of a fourth cohort to describe the immune response to authorised and new 30 mcg Bivalent and Monovalent Omicron BA.4/BA.5–modified BNT162b vaccines: 1. BNT162b2 Bivalent (Original/OMI BA.4/BA.5) 2. BNT162b5 Bivalent (Original/OMI BA.4/BA.5) 3. BNT162b7 Bivalent (Original/OMI BA.4/BA.5) 4. BNT162b7 Monovalent (OMI BA.4/BA.5) given to mRNA COVID-19 vaccine–experienced participants 18 through 55 years of age. Added corresponding objectives, estimands, and endpoints and details in the statistical methods sections. Study intervention details and background information supporting the inclusion of this cohort were also added.
    27 Jul 2023
    Addition of BNT162b6 vaccine into Cohort 4 to describe the immune response to this new 30 mcg Bivalent Omicron BA.4/BA.5–modified BNT162b vaccine: BNT162b6 Bivalent (Original/OMI BA.4/BA.5) given to mRNA COVID 19 vaccine–experienced participants 18 through 55 years of age. Updated corresponding objectives and details in the statistical methods sections. Study intervention details and background information supporting the inclusion of this vaccine were also added.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 03 06:34:51 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA