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    Clinical Trial Results:
    A Phase 3, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production LOTS and Dose Levels of The Vaccine Candidate BNT162b2 Against COVID-19 in Healthy Participants 12 Through 50 Years of Age and the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA-Based COVID-19 Vaccine Candidates as a Booster Dose in Healthy Participants 18 Through 50 Years of Age

    Summary
    EudraCT number
    		 2021-005903-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Jul 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Jan 2023
    First version publication date
    06 Feb 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    C4591017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04713553
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To demonstrate that the immune responses induced by BNT162b2 are similar across the 3 US lots (Arms 1, 2, and 3) in subjects without evidence of SARS CoV-2 infection during the study. 2) To demonstrate that the immune response induced by the EU lot (Arm 4) of BNT162b2 is similar to the pooled US lots (Arms 1, 2, and 3) in subjects without evidence of SARS-CoV-2 infection during the study. 3) To demonstrate the non-inferiority of the immune response to BNT162b2 in subjects receiving 20 microgram (mcg) compared to subjects receiving the standard 30 mcg dose (prepared from the same manufacturing lot) without evidence of SARS-CoV-2 infection during the study. 4) To evaluate the safety of BNT162b2 when administered on a 2-dose schedule in healthy subjects 12 through 50 years of age.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1573
    Worldwide total number of subjects
    1573
    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)
    445
    Adults (18-64 years)
    1128
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in two parts: primary study and booster study.

    Pre-assignment
    Screening details
    		 Total number of subjects enrolled in study and assigned to study intervention were 1574, however, only 1573 subjects received study intervention (1 subject was excluded for not meeting inclusion criteria).

    Period 1
    Period 1 title
    Primary Study (2 Months)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BNT162b2 30 mcg: US Lot 1
    Arm description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2 30 mcg single dose vaccine at Visit 1 and 2 separated by 21 days.

    Arm title
    		 BNT162b2 30 mcg: US Lot 2
    Arm description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2 30 mcg single dose vaccine at Visit 1 and 2 separated by 21 days.

    Arm title
    		 BNT162b2 30 mcg: US Lot 3
    Arm description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2 30 mcg single dose vaccine at Visit 1 and 2 separated by 21 days.

    Arm title
    		 BNT162b2 30 mcg: EU Lot
    Arm description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2 30 mcg single dose vaccine at Visit 1 and 2 separated by 21 days.

    Arm title
    		 BNT162b2 20 mcg: US Lot 1
    Arm description
    		 Subjects were randomised in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2 20 mcg single dose vaccine at Visit 1 and 2 separated by 21 days.

    Number of subjects in period 1
    		BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1
    Started
    351
    352
    346
    173
    351
    Completed
    347
    346
    344
    171
    349
    Not completed
    4
    6
    2
    2
    2
         Consent withdrawn by subject
    2
    3
    -
    -
    1
         Not specified
    1
    2
    -
    -
    1
         Lost to follow-up
    1
    1
    2
    1
    -
         Withdrawal by parent/guardian
    -
    -
    -
    1
    -
    Period 2
    Period 2 title
    Booster Study (1 Month)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 BNT162b2 30 mcg: Booster Dose
    Arm description
    		 Subjects who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomised to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Subjects were followed up for safety for up to 28-35 days after vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2 30 mcg single dose vaccine at Visit 4.

    Arm title
    		 BNT162b2.B.1.351 30 mcg: Booster Dose
    Arm description
    		 Subjects who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomised to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Subjects were followed up for safety for up to 28-35 days after vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2.B.1.351
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received BNT162b2.B.1.351 30 mcg single dose vaccine at Visit 4.

    Number of subjects in period 2
    		BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Started
    31
    31
    Completed
    31
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BNT162b2 30 mcg: US Lot 1
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: US Lot 2
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: US Lot 3
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: EU Lot
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 20 mcg: US Lot 1
    Reporting group description
    		 Subjects were randomised in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Total
    Number of subjects
    		 351 352 346 173 351 1573
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 99 96 101 48 101 445
        Adults (18-64 years)
    		 252 256 245 125 250 1128
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 28.0 ( 11.66 ) 27.8 ( 11.76 ) 27.5 ( 11.54 ) 27.7 ( 11.40 ) 27.5 ( 11.71 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 177 176 159 83 163 758
        Male
    		 174 176 187 90 188 815
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1 0 3 5
        Asian
    		 36 48 40 24 44 192
        Native Hawaiian or Other Pacific Islander
    		 1 1 1 0 2 5
        Black or African American
    		 21 16 15 2 14 68
        White
    		 286 280 283 142 283 1274
        More than one race
    		 6 5 5 4 5 25
        Unknown or Not Reported
    		 1 1 1 1 0 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 44 32 55 22 42 195
        Not Hispanic or Latino
    		 306 319 291 151 309 1376
        Unknown or Not Reported
    		 1 1 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    BNT162b2 30 mcg: US Lot 1
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: US Lot 2
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: US Lot 3
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: EU Lot
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 20 mcg: US Lot 1
    Reporting group description
    		 Subjects were randomised in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
    Reporting group title
    BNT162b2 30 mcg: Booster Dose
    Reporting group description
    		 Subjects who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomised to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Subjects were followed up for safety for up to 28-35 days after vaccination.

    Reporting group title
    BNT162b2.B.1.351 30 mcg: Booster Dose
    Reporting group description
    		 Subjects who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomised to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Subjects were followed up for safety for up to 28-35 days after vaccination.

    Subject analysis set title
    Pooled US Lots
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Subject analysis set title
    BNT162b2; Arm 3 (US Lot 3)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Primary: Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study

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    End point title
    		 Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study [1]
    End point description
    Geometric mean concentration (GMC) of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of GMCs of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3. Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3
    Number of subjects analysed
    324
    311
    310
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    6299.5 (5835.4 to 6800.5)
    6231.9 (5763.7 to 6738.2)
    6774.8 (6264.9 to 7326.1)
    Statistical analysis title
    		 US Lot 1 vs US Lot 2
    Statistical analysis description
    GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
    Comparison groups
    BNT162b2 30 mcg: US Lot 2 v BNT162b2 30 mcg: US Lot 1
    Number of subjects included in analysis
    635
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.13
    Notes
    [2] - Equivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).
    Statistical analysis title
    		 US Lot 2 vs US Lot 3
    Statistical analysis description
    GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
    Comparison groups
    BNT162b2 30 mcg: US Lot 2 v BNT162b2 30 mcg: US Lot 3
    Number of subjects included in analysis
    621
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.03
    Notes
    [3] - Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).
    Statistical analysis title
    		 US Lot 1 vs US Lot 3
    Statistical analysis description
    GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
    Comparison groups
    BNT162b2 30 mcg: US Lot 1 v BNT162b2 30 mcg: US Lot 3
    Number of subjects included in analysis
    634
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.04
    Notes
    [4] - Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).

    Primary: Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study

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    End point title
    		 Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study [5]
    End point description
    GMC of full-length S-binding IgG level for EU lot and pooled US lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm) were determined and reported in the descriptive section. Assay results below the LLOQ were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratios of GMCs of BNT162b2 30 mcg: EU Lot and pooled US Lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm). Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: EU Lot Pooled US Lots
    Number of subjects analysed
    160
    945
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    6098.6 (5474.7 to 6793.7)
    6428.8 (6149.5 to 6720.7)
    Statistical analysis title
    		 EU Lot vs Pooled US Lots
    Statistical analysis description
    GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
    Comparison groups
    BNT162b2 30 mcg: EU Lot v Pooled US Lots
    Number of subjects included in analysis
    1105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.07
    Notes
    [6] - Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).

    Primary: Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study

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    End point title
    		 Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study [7]
    End point description
    Geometric mean titer for SARS-CoV-2 neutralizing titers for 20 mcg dose and 30 mcg dose of US Lot 1 was determined and reported in descriptive section. GMTs and 2-sided 95% CIs were calculated by exponentiating LS mean of titers and corresponding CIs based on linear regression model. Assay results below LLOQ were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and were calculated as the ratio of geometric mean titer of the 20-mcg dose (US Lot 1) to the geometric mean titer of the 30 mcg dose (US Lot 1). Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 20 mcg: US Lot 1
    Number of subjects analysed
    318
    324
    Units: Titer
        geometric mean (confidence interval 95%)
    906.3 (847.8 to 968.9)
    976.6 (914.1 to 1043.4)
    Statistical analysis title
    		 30 mcg vs 20 mcg
    Statistical analysis description
    GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
    Comparison groups
    BNT162b2 30 mcg: US Lot 1 v BNT162b2 20 mcg: US Lot 1
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.02
    Notes
    [8] - Noninferiority of the 20-μg dose to the corresponding 30-μg dose was said to be achieved if the lower limit of the 2-sided 95% CI for the GMR is >0.67.

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

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Primary Study [9]
    End point description
    Local reactions were collected by the subject using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 1. Redness, swelling, and pain at injection site after Dose 1 were reported. Safety population included all randomised subjects who received at least 1 dose of the study intervention. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 1
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots
    Number of subjects analysed
    351
    352
    345
    173
    351
    1048
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness
    1.1 (0.3 to 2.9)
    2.0 (0.8 to 4.1)
    2.9 (1.4 to 5.3)
    2.3 (0.6 to 5.8)
    2.0 (0.8 to 4.1)
    2.0 (1.2 to 3.0)
        Swelling
    2.0 (0.8 to 4.1)
    3.7 (2.0 to 6.2)
    3.8 (2.0 to 6.4)
    2.9 (0.9 to 6.6)
    3.4 (1.8 to 5.9)
    3.1 (2.2 to 4.4)
        Pain at injection site
    82.9 (78.6 to 86.7)
    79.3 (74.6 to 83.4)
    84.6 (80.4 to 88.3)
    86.1 (80.1 to 90.9)
    78.1 (73.4 to 82.3)
    82.3 (79.8 to 84.5)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Primary Study [10]
    End point description
    Local reactions were collected by the subject using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 2. Redness, swelling, and pain at injection site after Dose 2 were reported. Safety population included all randomised subjects who received at least 1 dose of the study intervention. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 2
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots
    Number of subjects analysed
    349
    350
    343
    172
    348
    1042
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness
    3.7 (2.0 to 6.3)
    4.0 (2.2 to 6.6)
    4.4 (2.5 to 7.1)
    2.9 (1.0 to 6.7)
    3.2 (1.6 to 5.6)
    4.0 (2.9 to 5.4)
        Swelling
    4.9 (2.9 to 7.7)
    6.0 (3.8 to 9.0)
    4.7 (2.7 to 7.5)
    3.5 (1.3 to 7.4)
    3.7 (2.0 to 6.3)
    5.2 (3.9 to 6.7)
        Pain at injection site
    80.2 (75.7 to 84.3)
    77.7 (73.0 to 82.0)
    83.1 (78.7 to 86.9)
    77.3 (70.3 to 83.4)
    79.6 (75.0 to 83.7)
    80.3 (77.8 to 82.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After any Dose: Primary Study

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After any Dose: Primary Study [11] [12]
    End point description
    Local reactions were collected by the subject using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. Redness, swelling, and pain at injection site after any dose were reported. Safety population included all randomised subjects who received at least 1 dose of the study intervention. 1 subject randomised to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the subject was included in both reporting groups (US Lot 1 and US Lot 3).
    End point type
    Primary
    End point timeframe
    Within 7 days after any dose
    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: Statistical Analysis was not planned 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots BNT162b2; Arm 3 (US Lot 3)
    Number of subjects analysed
    351
    352
    173
    351
    1049
    347
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness
    4.6 (2.6 to 7.3)
    5.4 (3.3 to 8.3)
    4.6 (2.0 to 8.9)
    4.6 (2.6 to 7.3)
    5.5 (4.2 to 7.1)
    6.6 (4.2 to 9.8)
        Swelling
    6.0 (3.7 to 9.0)
    8.8 (6.1 to 12.3)
    4.6 (2.0 to 8.9)
    6.3 (4.0 to 9.3)
    7.3 (5.8 to 9.1)
    7.2 (4.7 to 10.5)
        Pain at injection site
    90.9 (87.4 to 93.7)
    85.8 (81.7 to 89.3)
    91.3 (86.1 to 95.1)
    89.5 (85.8 to 92.5)
    89.2 (87.2 to 91.0)
    91.1 (87.6 to 93.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 3: Booster Study [13]
    End point description
    Local reactions were collected by the subject using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. Redness, swelling, and pain at injection site after Dose 3 were reported. Safety population included all randomised subjects who received dose 3 of the study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    31
    31
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness
    9.7 (2.0 to 25.8)
    3.2 (0.1 to 16.7)
        Swelling
    6.5 (0.8 to 21.4)
    6.5 (0.8 to 21.4)
        Pain at injection site
    90.3 (74.2 to 98.0)
    93.5 (78.6 to 99.2)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Primary Study [14]
    End point description
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorised as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 1 were reported. Safety population included all randomised subjects who received at least 1 dose of the study intervention. Here, “Overall Number of Subjects Analysed” = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 1
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots
    Number of subjects analysed
    351
    352
    345
    173
    351
    1048
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever >=38.0 C
    0.3 (0.0 to 1.6)
    0 (0.0 to 1.0)
    2.0 (0.8 to 4.1)
    1.2 (0.1 to 4.1)
    0 (0.0 to 1.0)
    0.8 (0.3 to 1.5)
        Fever >=38.0 C to 38.4 C
    0.3 (0.0 to 1.6)
    0 (0.0 to 1.0)
    1.2 (0.3 to 2.9)
    0.6 (0.0 to 3.2)
    0 (0.0 to 1.0)
    0.5 (0.2 to 1.1)
        Fever >38.4 C to 38.9 C
    0 (0.0 to 1.0)
    0 (0.0 to 1.0)
    0.6 (0.1 to 2.1)
    0.6 (0.0 to 3.2)
    0 (0.0 to 1.0)
    0.2 (0.0 to 0.7)
        Fever >38.9 C to 40.0 C
    0 (0.0 to 1.0)
    0 (0.0 to 1.0)
    0.3 (0.0 to 1.6)
    0 (0.0 to 2.1)
    0 (0.0 to 1.0)
    0.1 (0.0 to 0.5)
        Fever >40.0 C
    0 (0.0 to 1.0)
    0 (0.0 to 1.0)
    1 (0.0 to 1.1)
    0 (0.0 to 2.1)
    0 (0.0 to 1.0)
    0 (0.0 to 0.4)
        Fatigue
    53.3 (47.9 to 58.6)
    45.5 (40.2 to 50.8)
    50.7 (45.3 to 56.1)
    49.1 (41.5 to 56.8)
    49.0 (43.7 to 54.4)
    49.8 (46.7 to 52.9)
        Headache
    36.2 (31.1 to 41.5)
    32.7 (27.8 to 37.8)
    33.3 (28.4 to 38.6)
    38.7 (31.4 to 46.4)
    35.6 (30.6 to 40.9)
    34.1 (31.2 to 37.0)
        Chills
    8.5 (5.8 to 12.0)
    7.7 (5.1 to 11.0)
    10.1 (7.2 to 13.8)
    8.1 (4.5 to 13.2)
    6.8 (4.4 to 10.0)
    8.8 (7.1 to 10.7)
        Vomiting
    0.6 (0.1 to 2.0)
    0.6 (0.1 to 2.0)
    1.2 (0.3 to 2.9)
    0.6 (0.0 to 3.2)
    0.9 (0.2 to 2.5)
    0.8 (0.3 to 1.5)
        Diarrhea
    9.7 (6.8 to 13.3)
    8.0 (5.4 to 11.3)
    7.8 (5.2 to 11.2)
    9.2 (5.4 to 14.6)
    10.0 (7.0 to 13.6)
    8.5 (6.9 to 10.3)
        New/worsened muscle pain
    14.5 (11.0 to 18.7)
    13.1 (9.7 to 17.0)
    16.5 (12.8 to 20.9)
    17.3 (12.0 to 23.8)
    16.2 (12.5 to 20.5)
    14.7 (12.6 to 17.0)
        New/worsened joint pain
    6.8 (4.4 to 10.0)
    6.5 (4.2 to 9.6)
    7.0 (4.5 to 10.2)
    7.5 (4.1 to 12.5)
    6.6 (4.2 to 9.7)
    6.8 (5.3 to 8.5)
        Use of antipyretic/analgesic medication
    16.8 (13.0 to 21.1)
    14.5 (11.0 to 18.6)
    18.8 (14.9 to 23.4)
    22.0 (16.0 to 28.9)
    18.2 (14.3 to 22.7)
    16.7 (14.5 to 19.1)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Primary Study [15]
    End point description
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorised as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 2 were reported. Safety population included all randomised subjects who received at least 1 dose of the study intervention. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 2
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots
    Number of subjects analysed
    349
    350
    343
    172
    348
    1042
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever >=38.0 C
    7.2 (4.7 to 10.4)
    6.3 (4.0 to 9.4)
    6.7 (4.3 to 9.9)
    8.7 (5.0 to 14.0)
    5.7 (3.5 to 8.7)
    6.7 (5.3 to 8.4)
        Fever >=38.0 C to 38.4 C
    4.6 (2.6 to 7.3)
    3.4 (1.8 to 5.9)
    3.2 (1.6 to 5.7)
    6.4 (3.2 to 11.2)
    4.3 (2.4 to 7.0)
    3.7 (2.7 to 5.1)
        Fever >38.4 C to 38.9 C
    2.0 (0.8 to 4.1)
    2.0 (0.8 to 4.1)
    2.3 (1.0 to 4.5)
    1.2 (0.1 to 4.1)
    1.4 (0.5 to 3.3)
    2.1 (1.3 to 3.2)
        Fever >38.9 C to 40.0 C
    0.6 (0.1 to 2.1)
    0.9 (0.2 to 2.5)
    0.9 (0.2 to 2.5)
    1.2 (0.1 to 4.1)
    0 (0.0 to 1.1)
    0.8 (0.3 to 1.5)
        Fever >40.0 C
    0 (0.0 to 1.1)
    0 (0.0 to 1.0)
    0.3 (0.0 to 1.6)
    0 (0.0 to 2.1)
    0 (0.0 to 2.1)
    0.1 (0.0 to 0.5)
        Fatigue
    69.9 (64.8 to 74.7)
    66.6 (61.4 to 71.5)
    71.4 (66.3 to 76.2)
    69.8 (62.3 to 76.5)
    66.7 (61.4 to 71.6)
    69.3 (66.4 to 72.1)
        Headache
    57.0 (51.6 to 62.3)
    56.6 (51.2 to 61.8)
    56.9 (51.4 to 62.2)
    56.4 (48.6 to 63.9)
    50.6 (45.2 to 55.9)
    56.8 (53.7 to 59.8)
        Chills
    28.1 (23.4 to 33.1)
    31.1 (26.3 to 36.3)
    33.8 (28.8 to 39.1)
    28.5 (21.9 to 35.9)
    23.6 (19.2 to 28.4)
    31.0 (28.2 to 33.9)
        Vomiting
    2.3 (1.0 to 4.5)
    1.4 (0.5 to 3.3)
    2.3 (1.0 to 4.5)
    1.7 (0.4 to 5.0)
    1.4 (0.5 to 3.3)
    2.0 (1.3 to 3.1)
        Diarrhea
    8.3 (5.6 to 11.7)
    9.1 (6.3 to 12.7)
    7.9 (5.3 to 11.2)
    9.3 (5.4 to 14.7)
    6.9 (4.5 to 10.1)
    8.4 (6.8 to 10.3)
        New/worsened muscle pain
    32.7 (27.8 to 37.9)
    38.6 (33.4 to 43.9)
    35.6 (30.5 to 40.9)
    36.0 (28.9 to 43.7)
    35.6 (30.6 to 40.9)
    35.6 (32.7 to 38.6)
        New/worsened joint pain
    19.2 (15.2 to 23.7)
    24.6 (20.2 to 29.4)
    19.2 (15.2 to 23.8)
    19.2 (13.6 to 25.9)
    19.5 (15.5 to 24.1)
    21.0 (18.6 to 23.6)
        Use of antipyretic/analgesic medication
    35.2 (30.2 to 40.5)
    41.1 (35.9 to 46.5)
    40.8 (35.6 to 46.2)
    41.9 (34.4 to 49.6)
    37.9 (32.8 to 43.3)
    39.1 (36.1 to 42.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After any Dose: Primary Study

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After any Dose: Primary Study [16] [17]
    End point description
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorised as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after any dose were reported. Safety population included all randomised subjects who received at least 1 dose of the study intervention. 1 subject randomised to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the subject was included in both reporting groups (US Lot 1 and US Lot 3).
    End point type
    Primary
    End point timeframe
    Within 7 days after any dose
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    [17] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots BNT162b2; Arm 3 (US Lot 3)
    Number of subjects analysed
    351
    352
    173
    351
    1049
    347
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever >=38.0 C
    7.4 (4.9 to 10.7)
    6.3 (4.0 to 9.3)
    9.2 (5.4 to 14.6)
    5.7 (3.5 to 8.7)
    7.3 (5.8 to 9.1)
    8.4 (5.7 to 11.8)
        Fever >=38.0 C to 38.4 C
    4.8 (2.8 to 7.6)
    3.4 (1.8 to 5.9)
    6.4 (3.2 to 11.1)
    4.3 (2.4 to 7.0)
    4.1 (3.0 to 5.5)
    4.0 (2.2 to 6.7)
        Fever >38.4 C to 38.9 C
    2.0 (0.8 to 4.1)
    2.0 (0.8 to 4.1)
    1.7 (0.4 to 5.0)
    1.4 (0.5 to 3.3)
    2.3 (1.5 to 3.4)
    2.9 (1.4 to 5.2)
        Fever >38.9 C to 40.0 C
    0.6 (0.1 to 2.0)
    0.9 (0.2 to 2.5)
    1.2 (0.1 to 4.1)
    0 (0.0 to 1.0)
    0.9 (0.4 to 1.6)
    1.2 (0.3 to 2.9)
        Fever >40.0 C
    0 (0.0 to 1.0)
    0 (0.0 to 1.0)
    0 (0.0 to 2.1)
    0 (0.0 to 1.0)
    0.1 (0.0 to 0.5)
    0.3 (0.0 to 1.6)
        Fatigue
    78.6 (74.0 to 82.8)
    73.6 (68.6 to 78.1)
    76.9 (69.9 to 82.9)
    75.5 (70.7 to 79.9)
    77.8 (75.1 to 80.3)
    81.0 (76.4 to 85.0)
        Headache
    66.7 (61.5 to 71.6)
    65.1 (59.8 to 70.0)
    68.8 (61.3 to 75.6)
    63.8 (58.5 to 68.9)
    65.4 (62.4 to 68.3)
    64.3 (59.0 to 69.3)
        Chills
    32.8 (27.9 to 37.9)
    34.1 (29.1 to 39.3)
    32.4 (25.5 to 39.9)
    26.2 (21.7 to 31.1)
    34.7 (31.8 to 37.7)
    37.2 (32.1 to 42.5)
        Vomiting
    2.8 (1.4 to 5.2)
    2.0 (0.8 to 4.1)
    2.3 (0.6 to 5.8)
    2.3 (1.0 to 4.4)
    2.8 (1.9 to 3.9)
    3.5 (1.8 to 6.0)
        Diarrhea
    16.2 (12.5 to 20.5)
    14.2 (10.7 to 18.3)
    15.0 (10.1 to 21.2)
    15.4 (11.8 to 19.6)
    14.8 (12.7 to 17.1)
    13.8 (10.4 to 17.9)
        New/worsened muscle pain
    38.7 (33.6 to 44.1)
    43.5 (38.2 to 48.8)
    43.9 (36.4 to 51.7)
    40.5 (35.3 to 45.8)
    41.8 (38.8 to 44.9)
    43.2 (37.9 to 48.6)
        New/worsened joint pain
    23.4 (19.0 to 28.1)
    27.3 (22.7 to 32.2)
    24.3 (18.1 to 31.4)
    22.2 (18.0 to 26.9)
    24.9 (22.3 to 27.6)
    23.9 (19.5 to 28.8)
        Use of antipyretic/analgesic medication medication
    41.9 (36.7 to 47.2)
    43.8 (38.5 to 49.1)
    51.4 (43.7 to 59.1)
    43.6 (38.3 to 49.0)
    44.0 (41.0 to 47.1)
    46.4 (41.1 to 51.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 3: Booster Study [18]
    End point description
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorised as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 3 were reported. Safety population included all randomised subjects who received dose 3 of the study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 3
    Notes
    [18] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    31
    31
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever >=38.0 C
    3.2 (0.1 to 16.7)
    6.5 (0.8 to 21.4)
        Fever >=38.0 C to 38.4 C
    0 (0.0 to 11.2)
    6.5 (0.8 to 21.4)
        Fever >38.4 C to 38.9 C
    3.2 (0.1 to 16.7)
    0 (0.0 to 11.2)
        Fever >38.9 C to 40.0 C
    0 (0.0 to 11.2)
    0 (0.0 to 11.2)
        Fever >40.0 C
    0 (0.0 to 11.2)
    0 (0.0 to 11.2)
        Fatigue
    67.7 (48.6 to 83.3)
    83.9 (66.3 to 94.5)
        Headache
    41.9 (24.5 to 60.9)
    58.1 (39.1 to 75.5)
        Chills
    25.8 (11.9 to 44.6)
    19.4 (7.5 to 37.5)
        Vomiting
    3.2 (0.1 to 16.7)
    0 (0.0 to 11.2)
        Diarrhea
    16.1 (5.5 to 33.7)
    6.5 (0.8 to 21.4)
        New/worsened muscle pain
    41.9 (24.5 to 60.9)
    19.4 (7.5 to 37.5)
        New/worsened joint pain
    12.9 (3.6 to 29.8)
    12.9 (3.6 to 29.8)
        Use of antipyretic/analgesic medication
    32.3 (16.7 to 51.4)
    35.5 (19.2 to 54.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study [19]
    End point description
    An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. Safety population included all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months)
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 Pooled US Lots
    Number of subjects analysed
    351
    352
    346
    173
    351
    1049
    Units: Percentage of subjects
    number (not applicable)
        AEs, n=351,352,346,173,351,1049
    5.4
    6.0
    5.2
    10.4
    6.8
    5.5
        SAEs, n=351,352,346,173,351,1049
    0
    0
    0.3
    0.6
    0
    0.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study [20]
    End point description
    An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. Safety population included all randomised subjects who received dose 3 of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days)
    Notes
    [20] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    31
    31
    Units: Percentage of subjects
    number (not applicable)
        AEs, n=31, 31
    6.5
    3.2
        SAEs, n=31, 31
    0
    0
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study [21]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (prior to Dose 1 of Primary study)
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    25
    Units: Titer
        geometric mean (confidence interval 95%)
    20.5 (20.5 to 20.5)
    20.5 (20.5 to 20.5)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study [22]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2 of primary study
    Notes
    [22] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    25
    Units: Titer
        geometric mean (confidence interval 95%)
    971.4 (750.5 to 1257.4)
    749.0 (575.2 to 975.3)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study [23]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Titer
        geometric mean (confidence interval 95%)
    263.5 (186.9 to 371.3)
    224.2 (176.4 to 285.1)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study [24]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Week after Dose 3
    Notes
    [24] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Titer
        geometric mean (confidence interval 95%)
    2159.3 (1568.4 to 2972.8)
    1283.4 (939.4 to 1753.5)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study [25]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Titer
        geometric mean (confidence interval 95%)
    2035.5 (1502.2 to 2758.1)
    943.3 (699.1 to 1272.7)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster Study [26]
    End point description
    GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    Baseline (prior to Dose 1 of Primary study)
    Notes
    [26] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [27]
    0 [28]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [27] - Data was not analysed per Sponsor discretion.
    [28] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster Study [29]
    End point description
    GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2 of primary study
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [30]
    0 [31]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [30] - Data was not analysed per Sponsor discretion.
    [31] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study [32]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3
    Notes
    [32] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Titer
        geometric mean (confidence interval 95%)
    103.0 (75.4 to 140.8)
    94.0 (67.5 to 130.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study [33]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Week after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Titer
        geometric mean (confidence interval 95%)
    1614.1 (1172.8 to 2221.6)
    1729.8 (1160.0 to 2579.4)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study [34]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 3
    Notes
    [34] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Titer
        geometric mean (confidence interval 95%)
    1358.4 (968.5 to 1905.1)
    1411.1 (950.1 to 2095.9)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study [35]
    End point description
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (prior to Dose 1 of Primary study)
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    3.4 (2.0 to 5.7)
    3.4 (2.3 to 5.1)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study [36]
    End point description
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2 of primary study
    Notes
    [36] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    6529.1 (5212.9 to 8177.6)
    3796.9 (1899.8 to 7588.4)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study [37]
    End point description
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    1834.5 (1458.5 to 2307.5)
    1851.6 (1441.9 to 2377.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study [38]
    End point description
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Week after Dose 3
    Notes
    [38] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    10756.9 (8478.9 to 13647.0)
    10412.3 (7733.0 to 14020.0)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study [39]
    End point description
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    7983.0 (6266.0 to 10170.6)
    6676.9 (5242.6 to 8503.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study [40]
    End point description
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Week after Dose 3
    Notes
    [40] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    1.6 (1.3 to 2.0)
    2.7 (1.3 to 5.9)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study [41]
    End point description
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Month after Dose 3
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    1.2 (1.0 to 1.5)
    1.8 (0.9 to 3.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study [42]
    End point description
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3 to 1 Week after Dose 3
    Notes
    [42] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    5.9 (4.9 to 7.0)
    5.6 (4.4 to 7.2)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study [43]
    End point description
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3 to 1 Month after Dose 3
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    4.4 (3.7 to 5.2)
    3.6 (2.9 to 4.5)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study [44]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Week after Dose 3
    Notes
    [44] - 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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    2.2 (1.6 to 3.0)
    1.7 (1.3 to 2.2)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study [45]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Month after Dose 3
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    2.1 (1.6 to 2.7)
    1.2 (0.9 to 1.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study [46]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3 to 1 Week after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    8.2 (5.3 to 12.7)
    5.7 (4.5 to 7.3)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study [47]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3 to 1 Month after Dose 3
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    7.7 (5.6 to 10.7)
    4.2 (3.2 to 5.5)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study [48]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Week after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [49]
    0 [50]
    Units: Fold rise
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [49] - Data was not analysed per Sponsor discretion.
    [50] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study [51]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Month after Dose 3
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [52]
    0 [53]
    Units: Fold rise
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [52] - Data was not analysed per Sponsor discretion.
    [53] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study [54]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analyzed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3 to 1 Week after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    15.7 (11.2 to 22.0)
    18.4 (13.8 to 24.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study [55]
    End point description
    Seroresponse was defined as greater than equal to (>=) 4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    25
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (87.2 to 100.0)
    100 (86.3 to 100.0)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study

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    End point title
    		 Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study [56]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs 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. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analyzed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3 to 1 Month after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    26
    Units: Fold rise
        geometric mean (confidence interval 95%)
    13.2 (9.6 to 18.1)
    15.0 (11.3 to 19.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to Reference Strain Before Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to Reference Strain Before Dose 3: Booster Study [57]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Before Dose 3
    Notes
    [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    25
    Units: Percentage of subjects
        number (confidence interval 95%)
    92.6 (75.7 to 99.1)
    92.0 (74.0 to 99.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study [58]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Week after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    25
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (87.2 to 100.0)
    100 (86.3 to 100.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study [59]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Booster evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, Dose 2 – primary study, Dose 3 – booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, “Overall Number of Subjects Analysed”= subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 3
    Notes
    [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    27
    25
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (87.2 to 100.0)
    100 (86.3 to 100.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study [60]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline and 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [61]
    0 [62]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [61] - Data was not analysed per Sponsor discretion.
    [62] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study [63]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    Before Dose 3
    Notes
    [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [64]
    0 [65]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [64] - Data was not analysed per Sponsor discretion.
    [65] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study [66]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    1 Week after Dose 3
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [67]
    0 [68]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [67] - Data was not analysed per Sponsor discretion.
    [68] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study [69]
    End point description
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. Data for this endpoint was not analysed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 3
    Notes
    [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
    Number of subjects analysed
    0 [70]
    0 [71]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [70] - Data was not analysed per Sponsor discretion.
    [71] - Data was not analysed per Sponsor discretion.
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study [72]
    End point description
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ. Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint and n=subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 1 Month after Dose 2
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot Pooled US Lots
    Number of subjects analysed
    324
    311
    310
    160
    945
    Units: Units per milliliter
    geometric mean (confidence interval 95%)
        Baseline, n=323,311,310,160,944
    3.1 (2.7 to 3.5)
    2.6 (2.3 to 3.0)
    2.6 (2.2 to 3.0)
    2.6 (2.1 to 3.2)
    2.8 (2.5 to 3.0)
        1 Month After Dose 2,n=324,311,310,160,945
    6269.8 (5717.7 to 6875.2)
    6222.3 (5721.5 to 6766.9)
    6818.9 (6280.9 to 7403.1)
    6098.9 (5446.0 to 6830.1)
    6428.7 (6116.6 to 6756.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study

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    End point title
    		 Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study [73]
    End point description
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline (before Dose 1) up to 1 Month after Dose 2
    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: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot Pooled US Lots
    Number of subjects analysed
    323
    311
    310
    160
    944
    Units: Fold rise
        geometric mean (confidence interval 95%)
    2036.6 (1744.5 to 2377.7)
    2367.1 (2028.6 to 2762.2)
    2645.2 (2271.2 to 3080.8)
    2373.8 (1901.2 to 2963.9)
    2331.9 (2133.7 to 2548.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMT) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg dose of BNT162b2 from US Lot 1: Primary Study

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    End point title
    		 Geometric Mean Titers (GMT) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg dose of BNT162b2 from US Lot 1: Primary Study [74]
    End point description
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ. Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 1 Month after Dose 2
    Notes
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 20 mcg: US Lot 1
    Number of subjects analysed
    324
    318
    Units: Titer
    geometric mean (confidence interval 95%)
        Baseline
    20.5 (20.5 to 20.5)
    20.5 (20.5 to 20.5)
        1 Month after Dose 2
    969.6 (905.7 to 1038.0)
    913.0 (843.4 to 988.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg dose of BNT162b2 from US Lot 1: Primary Study

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    End point title
    		 Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg dose of BNT162b2 from US Lot 1: Primary Study [75]
    End point description
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 at 1 month after Dose 2 to the geometric mean titers of SARS-CoV-2 at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ. Evaluable immunogenicity population: Subjects who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, “N”= subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline (before Dose 1) up to 1 Month after Dose 2
    Notes
    [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 20 mcg: US Lot 1
    Number of subjects analysed
    324
    318
    Units: Fold rise
        geometric mean (confidence interval 95%)
    47.3 (44.2 to 50.6)
    44.5 (41.1 to 48.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose
    Adverse event reporting additional description
    Safety population set. AEs included events collected in e-diary (systematic assessment) and events collected on CRF at each visit (non-systematic assessment).1 subject randomised to US Lot 1 was administered US Lot 1 for Dose 1 & US Lot 3 for Dose 2, therefore, subject was included in both reporting groups (US Lot 1&US Lot 3) for non-SAEs.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    BNT162b2 30 mcg: US Lot 1
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: US Lot 2
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: EU Lot
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 20 mcg: US Lot 1
    Reporting group description
    		 Subjects were randomised in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Reporting group title
    BNT162b2 30 mcg: Booster Dose
    Reporting group description
    		 Subjects who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomised to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Subjects were followed up for safety for up to 28-35 days after vaccination.

    Reporting group title
    BNT162b2.B.1.351 30 mcg: Booster Dose
    Reporting group description
    		 Subjects who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomised to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Subjects were followed up for safety for up to 28-35 days after vaccination.

    Reporting group title
    BNT162b2; Arm 3 (US Lot 3)
    Reporting group description
    		 Subjects were randomised in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Subjects were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.

    Serious adverse events
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose BNT162b2; Arm 3 (US Lot 3)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    1 / 173 (0.58%)
    0 / 351 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 347 (0.29%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Migrainosus
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    1 / 173 (0.58%)
    0 / 351 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    0 / 173 (0.00%)
    0 / 351 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose BNT162b2; Arm 3 (US Lot 3)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    341 / 351 (97.15%)
    336 / 352 (95.45%)
    165 / 173 (95.38%)
    342 / 351 (97.44%)
    30 / 31 (96.77%)
    31 / 31 (100.00%)
    335 / 347 (96.54%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign abdominal neoplasm
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    0 / 173 (0.00%)
    0 / 351 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 347 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    234 / 351 (66.67%)
    229 / 352 (65.06%)
    119 / 173 (68.79%)
    224 / 351 (63.82%)
    13 / 31 (41.94%)
    18 / 31 (58.06%)
    223 / 347 (64.27%)
         occurrences all number
    234
    229
    119
    224
    13
    18
    223
    Syncope
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    2 / 173 (1.16%)
    0 / 351 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 347 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
    alternative assessment type: Systematic
         subjects affected / exposed
    115 / 351 (32.76%)
    120 / 352 (34.09%)
    56 / 173 (32.37%)
    92 / 351 (26.21%)
    8 / 31 (25.81%)
    6 / 31 (19.35%)
    129 / 347 (37.18%)
         occurrences all number
    115
    120
    56
    92
    8
    6
    129
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    276 / 351 (78.63%)
    259 / 352 (73.58%)
    133 / 173 (76.88%)
    265 / 351 (75.50%)
    21 / 31 (67.74%)
    26 / 31 (83.87%)
    281 / 347 (80.98%)
         occurrences all number
    276
    259
    133
    265
    21
    26
    281
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 351 (4.56%)
    19 / 352 (5.40%)
    8 / 173 (4.62%)
    16 / 351 (4.56%)
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    23 / 347 (6.63%)
         occurrences all number
    16
    19
    8
    16
    3
    1
    23
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    319 / 351 (90.88%)
    302 / 352 (85.80%)
    158 / 173 (91.33%)
    314 / 351 (89.46%)
    28 / 31 (90.32%)
    29 / 31 (93.55%)
    316 / 347 (91.07%)
         occurrences all number
    319
    302
    158
    314
    28
    29
    316
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 351 (5.98%)
    31 / 352 (8.81%)
    8 / 173 (4.62%)
    22 / 351 (6.27%)
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    25 / 347 (7.20%)
         occurrences all number
    21
    31
    8
    22
    2
    2
    25
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 351 (7.41%)
    22 / 352 (6.25%)
    16 / 173 (9.25%)
    20 / 351 (5.70%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    29 / 347 (8.36%)
         occurrences all number
    26
    22
    16
    20
    1
    2
    29
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    0 / 173 (0.00%)
    0 / 351 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 347 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    57 / 351 (16.24%)
    50 / 352 (14.20%)
    26 / 173 (15.03%)
    54 / 351 (15.38%)
    5 / 31 (16.13%)
    2 / 31 (6.45%)
    48 / 347 (13.83%)
         occurrences all number
    57
    50
    26
    54
    5
    2
    48
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 351 (2.85%)
    7 / 352 (1.99%)
    4 / 173 (2.31%)
    8 / 351 (2.28%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    12 / 347 (3.46%)
         occurrences all number
    10
    7
    4
    8
    1
    0
    12
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 352 (0.28%)
    3 / 173 (1.73%)
    2 / 351 (0.57%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 347 (0.29%)
         occurrences all number
    0
    1
    3
    2
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 351 (23.36%)
    96 / 352 (27.27%)
    42 / 173 (24.28%)
    78 / 351 (22.22%)
    4 / 31 (12.90%)
    4 / 31 (12.90%)
    83 / 347 (23.92%)
         occurrences all number
    82
    96
    42
    78
    4
    4
    83
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    136 / 351 (38.75%)
    153 / 352 (43.47%)
    76 / 173 (43.93%)
    142 / 351 (40.46%)
    13 / 31 (41.94%)
    6 / 31 (19.35%)
    150 / 347 (43.23%)
         occurrences all number
    136
    153
    76
    142
    13
    6
    150
    Neck pain
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 352 (0.00%)
    0 / 173 (0.00%)
    0 / 351 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 347 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2021
    A booster study was added in which an additional dose of either BNT162b2 or BNT162b2.B.1.351 (beta variant of concern) was given to a subset of 60 subjects 18 through 50 yrs of age, 3 months after Dose 2, for assessment of safety and immunogenicity.

    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
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    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.

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