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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 Subjects 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 Subjects 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
    		 v1
    This version publication date
    06 Feb 2022
    First version publication date
    06 Feb 2022
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    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 613190841919, patients@biontech.de
    Scientific contact
    BioNTech clinical trial information desk, BioNTech SE, +49 613190840, info@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
    06 Jan 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 noninferiority of the immune response to BNT162b2 in subjects receiving 20 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 were 1574, however 1573 subjects received investigational product (1 subject was excluded for not meeting inclusion criteria). 1 subject randomised to US Lot 1(Arm 1) was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, safety data was collected in both reporting group(Arm 1 and Arm 3).

    Period 1
    Period 1 title
    Primary Study
    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; Arm 1 (US Lot 1)
    Arm description
    		 Subjects were randomised to receive a single dose of 30 microgram (mcg) BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.
    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; Arm 2 (US Lot 2)
    Arm description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.
    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; Arm 3 (US Lot 3)
    Arm description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.
    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; Arm 4 (EU Lot)
    Arm description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.
    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; Arm 5 (20 mcg)
    Arm description
    		 Subjects were randomised to receive a single dose of 20 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.
    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; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    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
    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)
    Arm description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine by intramuscular injection at Visit 4 (3 months after Dose 2 in the primary study). Subjects participated in the study for 1 month with final visit at 1 month after Visit 4.
    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)
    Arm description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2.B.1.351 vaccine by intramuscular injection at Visit 4 (3 months after Dose 2 in the primary study). Subjects participated in the study for 1 month with final visit at 1 month after Visit 4.
    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) BNT162b2.B.1.351 (30 mcg)
    Started
    31
    31
    Completed
    31
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BNT162b2; Arm 1 (US Lot 1)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 microgram (mcg) BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 2 (US Lot 2)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 3 (US Lot 3)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 4 (EU Lot)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 5 (20 mcg)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 20 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg) 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 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 177 176 159 83 163 758
        Male
    		 174 176 187 90 188 815
    Race
    Units: Subjects
        White
    		 286 280 283 142 283 1274
        Asian
    		 36 48 40 24 44 192
        Black or African American
    		 21 16 15 2 14 68
        Multiracial
    		 6 5 5 4 5 25
        American Indian or Alaska Native
    		 0 1 1 0 3 5
        Native Hawaiian or other Pacific Islander
    		 1 1 1 0 2 5
        Not reported
    		 1 1 1 1 0 4
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 44 32 55 22 42 195
        Non-Hispanic/non-Latino
    		 306 319 291 151 309 1376
        Not reported
    		 1 1 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    BNT162b2; Arm 1 (US Lot 1)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 microgram (mcg) BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 2 (US Lot 2)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 3 (US Lot 3)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 4 (EU Lot)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 5 (20 mcg)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 20 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.
    Reporting group title
    BNT162b2 (30 mcg)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine by intramuscular injection at Visit 4 (3 months after Dose 2 in the primary study). Subjects participated in the study for 1 month with final visit at 1 month after Visit 4.

    Reporting group title
    BNT162b2.B.1.351 (30 mcg)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2.B.1.351 vaccine by intramuscular injection at Visit 4 (3 months after Dose 2 in the primary study). Subjects participated in the study for 1 month with final visit at 1 month after Visit 4.

    Subject analysis set title
    Pooled US Lots
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine (in Arm 1, 2, and 3) intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Subject analysis set title
    BNT162b2; Arm 3 (US Lot 3)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2. 1 subject randomised to US Lot 1 (Arm 1) was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, safety data was collected in both reporting groups (Arm 1 and Arm 3).

    Primary: Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between Individual US Lots 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 Individual US Lots 1 Month After Dose 2: Primary Study [1]
    End point description
    GMRs were calculated as ratios of Geometric Mean Concentrations (GMCs) of individual US Lots. Evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2 (maximum up to 35 days 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: The endpoint was planned to be analysed in specified arms only.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (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
    		 Geometric Mean Ratio (Arm 1/Arm 2)
    Comparison groups
    BNT162b2; Arm 1 (US Lot 1) v BNT162b2; Arm 2 (US Lot 2)
    Number of subjects included in analysis
    635
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    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
    Statistical analysis title
    		 Geometric Mean Ratio (Arm 1/Arm 3)
    Comparison groups
    BNT162b2; Arm 1 (US Lot 1) v BNT162b2; Arm 3 (US Lot 3)
    Number of subjects included in analysis
    634
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    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
    Statistical analysis title
    		 Geometric Mean Ratio (Arm 2/Arm 3)
    Comparison groups
    BNT162b2; Arm 2 (US Lot 2) v BNT162b2; Arm 3 (US Lot 3)
    Number of subjects included in analysis
    621
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    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

    Primary: Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots 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 1 Month After Dose 2: Primary Study [2]
    End point description
    GMRs were calculated as ratios of GMCs of EU Lot (Arm 4) and pooled US Lots (Arm 1, 2, and 3). Evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed in specified arms only.
    End point values
    		 BNT162b2; Arm 4 (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
    		 Geometric Mean Ratio (Arm 4/Pooled US Lots)
    Comparison groups
    BNT162b2; Arm 4 (EU Lot) v Pooled US Lots
    Number of subjects included in analysis
    1105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    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

    Primary: Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose 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 1 Month After Dose 2: Primary Study [3]
    End point description
    GMRs were calculated by exponentiating the mean difference of logarithmically transformed assay results between 2 vaccine groups. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 × LLOQ. Evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    Number of subjects analysed
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [4] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [5] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [6] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [7] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [8] - Data will be posted by 3rd Quarter of 2022 or sooner.
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 1 and 2: 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 (PAIS) for Dose 1 and 2. Redness, and swelling at any severity (>2.0 centimeters [cm]) were reported. Safety population included all randomised subjects who received at least 1 dose of study intervention. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint and ‘Number Analysed (n)’ signifies number of subjects evaluable for each specified row.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 1 and Dose 2
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    Number of subjects analysed
    351
    352
    345
    173
    351
    Units: Percentage of subjects
    number (confidence interval 95%)
        Dose 1: Redness (n=351,352,345,173,351)
    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)
        Dose1: Swelling (n=351,352,345,173,351)
    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)
        Dose 1: PAIS(n=351,352,345,173,351)
    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)
        Dose 2: Redness (n=349,350,343,172,348)
    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)
        Dose 2: Swelling (n=349,350,343,172,348)
    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)
        Dose 2: PAIS(n=349,350,343,172,348)
    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)
    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 [10] [11]
    End point description
    Local reactions were collected by the subject using an electronic diary. Local reactions included Redness, Swelling, and Pain at Injection site for “any dose”. Redness, and swelling scaled at any severity (>2.0 cm) were reported. Safety population included all randomised subjects who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 days after any dose
    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: Only descriptive data was planned to be reported for this endpoint
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed in specified arms only.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg) BNT162b2; Arm 3 (US Lot 3)
    Number of subjects analysed
    351
    352
    173
    351
    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)
    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)
    7.2 (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)
    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 [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 for Dose 3. Redness, and swelling scaled at any severity (>2.0 cm) were reported. Safety population included all randomised subjects who received dose 3. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 3
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    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 and 2: Primary Study

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 1 and 2: Primary Study [13]
    End point description
    Systemic events were reported using an electronic diary for any dose. Fever scales (fever>=38.0-38.4 degree Celsius [C]; >38.4-38.9 C; >38.9-40.0 C; >40.0 C). Fatigue, headache, chills, new or worsened muscle pain, joint pain, vomiting (>2 times in 24 hours), diarrhea (6 or more loose stools in 24 hours) at any severity were included. Safety population included all randomised subjects who received at least 1 dose of study intervention. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint and ‘Number Analysed (n)’ signifies number of subjects evaluable for each specified row.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 1 and Dose 2
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    Number of subjects analysed
    351
    352
    345
    173
    351
    Units: Percentage of subjects
    number (confidence interval 95%)
        Dose1:Fever>=38.0 C(n=351,352,345,173,351)
    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)
        Dose1:Fever>=38.0C to 38.4C(n=351,352,345,173,351)
    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)
        Dose1:Fever>38.4C to 38.9C(n=351,352,345,173,351)
    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)
        Dose1:Fever>38.9C to 40.0C(n=351,352,345,173,351)
    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)
        Dose1:Fever>40.0 C (n=351,352,345,173,351)
    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)
        Dose 1:Fatigue(n=351,352,345,173,351)
    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)
        Dose1:Headache(n=351,352,345,173,351)
    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)
        Dose1:Chills (n=351,352,345,173,351)
    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)
        Dose1:Vomiting (n=351,352,345,173,351)
    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)
        Dose 1:Diarrhea (n=351,352,345,173,351)
    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)
        Dose1:New/worsen musclepain(n=351,352,345,173,351)
    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)
        Dose1:New/worsen joint pain(n=351,352,345,173,351)
    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)
        Dose2:Fever>=38.0 C(n=349,350,343,172,348)
    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)
        Dose2:Fever>=38.0C to 38.4C(n=349,350,343,172,348)
    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)
        Dose2:Fever>38.4C to 38.9C(n=349,350,343,172,348)
    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)
        Dose2:Fever>38.9C to 40.0C(n=349,350,343,172,348)
    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)
        Dose 2:Fever >40.0 C (n=349,350,343,172,348)
    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)
        Dose 2: Fatigue(n=349,350,343,172,348)
    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)
        Dose 2: Headache(n=349,350,343,172,348)
    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)
        Dose 2: Chills (n=349,350,343,172,348)
    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)
        Dose 2:Vomiting (n=349,350,343,172,348)
    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)
        Dose 2:Diarrhea (n=349,350,343,172,348)
    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)
        Dose2:New/worsen musclepain(n=349,350,343,172,348)
    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)
        Dose2:New/worsen joint pain(n=349,350,343,172,348)
    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)
    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 [14] [15]
    End point description
    Systemic events were reported using an electronic diary for any dose. Fever scales (fever>=38.0-38.4 C; >38.4-38.9 C; >38.9-40.0 C; >40.0 C). Fatigue, headache, chills, new or worsened muscle pain, joint pain, vomiting (>2 times in 24 hours), diarrhea (6 or more loose stools in 24 hours) at any severity were included. Safety population included all randomised subjects who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 days after any dose
    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: Only descriptive data was planned to be reported for this endpoint.
    [15] - 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: The endpoint was planned to be analysed in specified arms only.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg) BNT162b2; Arm 3 (US Lot 3)
    Number of subjects analysed
    351
    352
    173
    351
    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)
    8.4 (5.7 to 11.8)
        Fever>=38.0C to 38.4C
    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)
    4.0 (2.2 to 6.7)
        Fever>38.4C to 38.9C
    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)
    2.9 (1.4 to 5.2)
        Fever>38.9C to 40.0C
    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)
    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)
    0.3 (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)
    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)
    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)
    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)
    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)
    13.8 (10.4 to 17.9)
        New/worsen 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)
    43.2 (37.9 to 48.6)
        New/worsen 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)
    23.9 (19.5 to 28.8)
    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 [16]
    End point description
    Systemic events were reported using an electronic diary for any dose. Fever scales (fever>=38.0-38.4 C; >38.4-38.9 C; >38.9-40.0 C; >40.0 C). Fatigue, headache, chills, new or worsened muscle pain, joint pain, vomiting (>2 times in 24 hours), diarrhea (6 or more loose stools in 24 hours) at any severity were included. Safety population included all randomised subjects who received dose 3. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 3
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    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>38.9C 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)
    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 [17]
    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 study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 (Day 1 of vaccination) up to 1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    Number of subjects analysed
    351
    352
    346
    173
    351
    Units: Percentage of subjects
    number (not applicable)
        AEs
    5.4
    6.0
    5.2
    10.4
    6.8
        SAEs
    0
    0
    0.3
    0.6
    0
    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 [18]
    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 (maximum up to 35 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    31
    31
    Units: Percentage of subjects
    number (not applicable)
        AEs
    6.5
    3.2
        SAEs
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline, 1 Month After Dose 2 and 1 Week After and 1 Month After Dose 3: Booster Study [19]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 1 Month after Dose 2 and 1 Week after and 1 Month after Dose 3
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint Validation report (Report created at 13:52:49 on 21-January-2022) Download validation report Expand all "More" links / Collapse all "Less" links Trial information No errors or warnings found. Subject disposition No errors or warnings found. Baseline characteristics No errors or warnings found. End points WARNING - End Point: Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgra
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [20] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [21] - Data will be posted by 3rd Quarter of 2022 or sooner.
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline, 1 Month After Dose 2 and 1 Week After and 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 at Baseline, 1 Month After Dose 2 and 1 Week After and 1 Month After Dose 3: Booster Study [22]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 1 Month after Dose 2 and 1 Week after and 1 Month after Dose 3
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [23]
    0 [24]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [23] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [24] - Data will be posted by 3rd Quarter of 2022 or sooner.
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline, 1 Month After Dose 2, and 1 Week After and 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 at Baseline, 1 Month After Dose 2, and 1 Week After and 1 Month After Dose 3: Booster Study [25]
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomized in the primary study with Dose 2 received within the predefined window, received Dose 3 to which they were randomized in the booster study with Dose 3 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 3, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during the primary and booster studies, and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    Baseline, 1 Month after Dose 2, and 1 Week after and 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: Only descriptive data was planned to be reported for this endpoint
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [26] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [27] - Data will be posted by 3rd Quarter of 2022 or sooner.
    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 and 1 Month After Dose 3 and From Before Dose 3 to 1 Week After and 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 Week After and 1 Month After Dose 3 and From Before Dose 3 to 1 Week After and 1 Month After Dose 3: Booster Study [28]
    End point description
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomized in the primary study with Dose 2 received within the predefined window, received Dose 3 to which they were randomized in the booster study with Dose 3 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 3, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during the primary and booster studies, and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Week after and 1 Month after Dose 3 and from before Dose 3 to 1 Week after and 1 Month after Dose 3
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [29]
    0 [30]
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [29] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [30] - Data will be posted by 3rd Quarter of 2022 or sooner.
    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 and 1 Month After Dose 3 and From Before Dose 3 to 1 Week After and 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 Week After and 1 Month After Dose 3 and From Before Dose 3 to 1 Week After and 1 Month After Dose 3: Booster Study [31]
    End point description
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomized in the primary study with Dose 2 received within the predefined window, received Dose 3 to which they were randomized in the booster study with Dose 3 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 3, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during the primary and booster studies, and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Week after and 1 Month after Dose 3 and from before Dose 3 to 1 Week after and 1 Month after Dose 3
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [32]
    0 [33]
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [32] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [33] - Data will be posted by 3rd Quarter of 2022 or sooner.
    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 and 1 Month After Dose 3 and From Before Dose 3 to 1 Week After and 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 Week After and 1 Month After Dose 3 and From Before Dose 3 to 1 Week After and 1 Month After Dose 3: Booster Study [34]
    End point description
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomized in the primary study with Dose 2 received within the predefined window, received Dose 3 to which they were randomized in the booster study with Dose 3 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 3, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during the primary and booster studies, and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    From 1 Month after Dose 2 to 1 Week after and 1 Month after Dose 3 and from before Dose 3 to 1 Week after and 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [35]
    0 [36]
    Units: Unit per milliliter
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [35] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [36] - Data will be posted by 3rd Quarter of 2022 or sooner.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroresponse to Reference Strain at 1 Month After Dose 2, Before Dose 3, and 1 Week After and 1 Month After Dose 3: Booster Study

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    End point title
    		 Percentage of Subjects With Seroresponse to Reference Strain at 1 Month After Dose 2, Before Dose 3, and 1 Week After and 1 Month After Dose 3: Booster Study [37]
    End point description
    Seroresponse was defined as greater than equal to (≥) 4-fold increase from baseline (before Dose 1) to the specified time point. If the baseline measurement was below LLOQ, a postvaccination measurement of ≥4 × LLOQ was considered a seroresponse. Evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomized in the primary study with Dose 2 received within the predefined window, received Dose 3 to which they were randomized in the booster study with Dose 3 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 3 visit, were negative for SARS-CoV-2 infection during the primary and booster studies, and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2, before Dose 3, and 1 Week after and 1 Month after 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [38]
    0 [39]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [38] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [39] - Data will be posted by 3rd Quarter of 2022 or sooner.
    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, Before Dose 3, and 1 Week After and 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 at 1 Month After Dose 2, Before Dose 3, and 1 Week After and 1 Month After Dose 3: Booster Study [40]
    End point description
    Seroresponse was defined as ≥4-fold increase from baseline (before Dose 1) to the specified time point. If the baseline measurement was below LLOQ, a postvaccination measurement of ≥4 × LLOQ was considered a seroresponse. Evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomized in the primary study with Dose 2 received within the predefined window, received Dose 3 to which they were randomized in the booster study with Dose 3 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 3 visit, were negative for SARS-CoV-2 infection during the primary and booster studies, and had no other important protocol deviations as determined by the clinician.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2, before Dose 3, and 1 Week after and 1 Month 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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 BNT162b2 (30 mcg) BNT162b2.B.1.351 (30 mcg)
    Number of subjects analysed
    0 [41]
    0 [42]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [41] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [42] - Data will be posted by 3rd Quarter of 2022 or sooner.
    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: 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: Primary Study [43]
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint and ‘Number Analysed (n)’ signifies number of subjects evaluable for each specified row.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    Notes
    [43] - 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: The endpoint was planned to be analysed in specified arms only.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot)
    Number of subjects analysed
    324
    311
    310
    160
    Units: Unit per milliliter
    geometric mean (confidence interval 95%)
        Baseline (n=323, 311, 310, 160)
    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)
        1 Month After Dose 2 (n=324, 311, 310, 160)
    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)
    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: 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: Primary Study [44]
    End point description
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline (before Dose 1) up to 1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be analysed in specified arms only.
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot)
    Number of subjects analysed
    323
    311
    310
    160
    Units: Unit per milliliter
        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)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2: Primary Study

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    End point title
    		 Geometric Mean Concentrations (GMCs) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2: Primary Study
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    Number of subjects analysed
    0 [45]
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [45] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [46] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [47] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [48] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [49] - Data will be posted by 3rd Quarter of 2022 or sooner.
    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: 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: Primary Study
    End point description
    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 included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomised with Dose 2 received within the predefined window, had at least 1 valid immunogenicity result from the blood sample collected within an appropriate window at 1 month after the Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody)during the study and had no other important protocol deviations as determined by the clinician.
    End point type
    Secondary
    End point timeframe
    From Baseline (before Dose 1) up to 1 Month after Dose 2 (maximum up to 35 days after Dose 2)
    End point values
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 3 (US Lot 3) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg)
    Number of subjects analysed
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    0 [54]
    Units: Units per milliliter
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [50] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [51] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [52] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [53] - Data will be posted by 3rd Quarter of 2022 or sooner.
    [54] - Data will be posted by 3rd Quarter of 2022 or sooner.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs (primary study): From Dose 1 to 1 Month after Dose 2 (up to 35 days after Dose 2); AEs and SAEs (booster study): From Dose 3 to 1 Month after Dose 3 (up to 35 days after Dose 3); Local reactions/systemic events: Within 7 days after each dose
    Adverse event reporting additional description
    Safety populations: subjects who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    BNT162b2; Arm 1 (US Lot 1)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 2 (US Lot 2)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 4 (EU Lot)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2; Arm 5 (20 mcg)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 20 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2.

    Reporting group title
    BNT162b2
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine by intramuscular injection at Visit 4 (3 months after Dose 2 in the primary study). Subjects participated in the study for 1 month with final visit at 1 month after Visit 4.

    Reporting group title
    BNT162b2.B.1.351
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2.B.1.351 vaccine by intramuscular injection at Visit 4 (3 months after Dose 2 in the primary study). Subjects participated in the study for 1 month with final visit at 1 month after Visit 4.

    Reporting group title
    BNT162b2; Arm 3 (US Lot)
    Reporting group description
    		 Subjects were randomised to receive a single dose of 30 mcg BNT162b2 vaccine intramuscular injection at each vaccination visit (Visits 1 and 2) separated by 21 days. Subjects participated in the study for 2 months with final visit at 1 month after Visit 2. 1 subject randomised to US Lot 1 (Arm 1) was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, safety data was collected in both reporting groups (Arm 1 and Arm 3).

    Serious adverse events
    		 BNT162b2; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg) BNT162b2 BNT162b2.B.1.351 BNT162b2; Arm 3 (US Lot)
    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
    0
    0
    0
    0
    0
    0
    0
    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; Arm 1 (US Lot 1) BNT162b2; Arm 2 (US Lot 2) BNT162b2; Arm 4 (EU Lot) BNT162b2; Arm 5 (20 mcg) BNT162b2 BNT162b2.B.1.351 BNT162b2; Arm 3 (US Lot)
    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

    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.
    Data for neutralizing titers in the primary study and all immunogenicity data in the booster study will be posted in 3rd Quarter of 2022 or sooner when the data becomes available
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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