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    Clinical Trial Results:
    A Phase 3 Master Protocol to Evaluate Additional Dose(s) Of BNT162b2 In Healthy Individuals Previously Vaccinated With BNT162b2

    Summary
    EudraCT number
    		 2021-005197-25
    Trial protocol
    		 DE  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    18 May 2023
    First version publication date
    18 May 2023
    Other versions
    		 v2 , v3 , v4

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C4591031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04955626
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech SE, BioNTech clinical trials patient information, +49 6131 90840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    Interim
    Date of interim/final analysis
    01 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    Sub Study A (SSA): To describe the efficacy of a booster dose of BNT162b2 against confirmed COVID-19 occurring from 7 days after the booster dose through the blinded follow-up period in participants without evidence of past SARS-CoV-2 infection. To describe the efficacy of a booster dose of BNT162b2 against confirmed COVID-19 occurring from 7 days after the booster dose through the blinded follow-up period in participants with and without evidence of past SARS-CoV-2 infection. To define the safety profile of a booster dose of BNT162b2.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 1164
    Country: Number of subjects enrolled
    South Africa: 268
    Country: Number of subjects enrolled
    United States: 8689
    Worldwide total number of subjects
    10121
    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)
    90
    Adults (18-64 years)
    7670
    From 65 to 84 years
    2340
    85 years and over
    21

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 10137 subjects were enrolled. Out of which 10125 subjects were evaluated, of which 4 subjects were multiple enrolled. 10121 subjects were randomized to receive the study drug and were treated.

    Period 1
    Period 1 title
    SSA: Blinded Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BNT162b2 30 microgram (mcg)
    Arm description
    		 Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 microgram administered intramuscularly

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline solution of 0.9 percent [%] sodium chloride

    Number of subjects in period 1
    		BNT162b2 30 microgram (mcg) Placebo
    Started
    5080
    5041
    Completed
    421
    22
    Not completed
    4659
    5019
         Adverse event, serious fatal
    -
    2
         Physician decision
    1
    1
         Consent withdrawn by subject
    26
    62
         No longer meets eligibility criteria
    1
    2
         Adverse event, non-fatal
    -
    1
         Subjects entered open label period
    4544
    4906
         Unspecified
    54
    3
         Lost to follow-up
    28
    28
         Protocol deviation
    5
    14
    Period 2
    Period 2 title
    SSA: Open label (OL) period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 BNT162b2 30 microgram
    Arm description
    		 Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 microgram administered intramuscularly

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline solution of 0.9 percent [%] sodium chloride

    Number of subjects in period 2
    		BNT162b2 30 microgram Placebo
    Started
    4544
    4906
    Completed
    3272
    73
    Not completed
    1272
    4833
         Adverse event, serious fatal
    5
    -
         Withdrawn by parent/guardian
    1
    -
         Physician decision
    2
    3
         Consent withdrawn by subject
    135
    109
         Adverse event, non-fatal
    1
    -
         No longer meets eligibility criteria
    20
    11
         Refused further study procedures
    1
    1
         Pregnancy
    -
    1
         Subjects received BNT162b2 30 microgram
    -
    4430
         Unspecified
    621
    13
         Lost to follow-up
    109
    34
         Protocol deviation
    377
    231
    Period 3
    Period 3 title
    SSA: OL: Placebo then BNT162b2 30 mcg
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Placebo then BNT162b2 (30 microgram)
    Arm description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline solution of 0.9 percent [%] sodium chloride

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 microgram administered intramuscularly

    Number of subjects in period 3
    		Placebo then BNT162b2 (30 microgram)
    Started
    4430
    Completed
    3878
    Not completed
    552
         Adverse event, serious fatal
    5
         Consent withdrawn by subject
    25
         No longer meets eligibility criteria
    4
         Unspecified
    429
         Lost to follow-up
    41
         Protocol deviation
    48

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BNT162b2 30 microgram (mcg)
    Reporting group description
    		 Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.

    Reporting group values
    		 BNT162b2 30 microgram (mcg) Placebo Total
    Number of subjects
    		 5080 5041 10121
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 46 44 90
        Adults (18-64 years)
    		 3859 3811 7670
        From 65-84 years
    		 1166 1174 2340
        85 years and over
    		 9 12 21
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.8 ( 15.24 ) 51.7 ( 15.33 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 2624 2526 5150
        Male
    		 2456 2515 4971
    Race
    Units: Subjects
        White
    		 3998 4002 8000
        Black or African American
    		 470 457 927
        American Indian or Alaska Native
    		 86 92 178
        Asian
    		 288 269 557
        Native Hawaiian or other Pacific Islander
    		 7 11 18
        Multiracial
    		 209 197 406
        Not reported
    		 22 13 35
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 759 750 1509
        Non-Hispanic/non-Latino
    		 4309 4283 8592
        Not reported
    		 12 8 20

    End points

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    End points reporting groups
    Reporting group title
    BNT162b2 30 microgram (mcg)
    Reporting group description
    		 Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
    Reporting group title
    BNT162b2 30 microgram
    Reporting group description
    		 Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.
    Reporting group title
    Placebo then BNT162b2 (30 microgram)
    Reporting group description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

    Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population

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    End point title
    		 SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population
    End point description
    Occurrences of first COVID-19 infection in subjects after booster dose with and without past SARS-CoV-2 infection at interim analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 7 Days after booster vaccination (median 2.5 Months after booster dose)
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4993
    4952
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    0.871
    0.835
    Statistical analysis title
    		 BNT162b2 30 μg versus Placebo
    Statistical analysis description
    2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.
    Comparison groups
    BNT162b2 30 microgram (mcg) v Placebo
    Number of subjects included in analysis
    9945
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Surveillance Time
    Point estimate
    94.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 88.5
         upper limit
    		 97.9

    Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population

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    End point title
    		 SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population
    End point description
    Occurrences of first COVID-19 infection in subjects after booster dose without past SARS-CoV-2 infection at interim analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 7 Days after booster vaccination (median 2.5 Months after booster dose)
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4695
    4671
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    0.823
    0.792
    Statistical analysis title
    		 BNT162b2 30 μg versus Placebo
    Statistical analysis description
    2-Sided CI for Relative vaccine efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.
    Comparison groups
    BNT162b2 30 microgram (mcg) v Placebo
    Number of subjects included in analysis
    9366
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Surveillance Time
    Point estimate
    95.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 89.5
         upper limit
    		 98.3

    Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population

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    End point title
    		 SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population
    End point description
    Occurrences of first COVID-19 infection in subjects after booster dose with and without past SARS-CoV-2 infection at final analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 7 Days after booster vaccination (median 2.8 Months after booster dose)
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4977
    4942
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    1.173
    0.989
    Statistical analysis title
    		 BNT162b2 30 μg versus Placebo
    Statistical analysis description
    2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.
    Comparison groups
    BNT162b2 30 microgram (mcg) v Placebo
    Number of subjects included in analysis
    9919
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Surveillance Time
    Point estimate
    62.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.5
         upper limit
    		 72.2

    Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population

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    End point title
    		 SSA: Occurrence of First COVID-19 Infection After Booster Dose per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population
    End point description
    Occurrences of first COVID-19 infection in subjects after booster dose without past SARS-CoV-2 infection at final analysis were reported in this end point. Evaluable efficacy population included all eligible randomised subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 7 Days after booster vaccination (median 2.8 Months after booster dose)
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4689
    4664
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    1.098
    0.932
    Statistical analysis title
    		 BNT162b2 30 μg versus Placebo
    Statistical analysis description
    2-Sided CI for Relative Vaccine Efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.
    Comparison groups
    BNT162b2 30 microgram (mcg) v Placebo
    Number of subjects included in analysis
    9353
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Surveillance Time
    Point estimate
    63.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.1
         upper limit
    		 73.5

    Primary: SSA: Number of Subjects Reporting Adverse Events

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    End point title
    		 SSA: Number of Subjects Reporting Adverse Events [1]
    End point description
    An AE was any untoward medical occurrence in a subject temporally associated with the use of study intervention, whether or not considered related to the study intervention. Safety population included all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From booster dose to 1 month after booster dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo Placebo
    Number of subjects analysed
    5080
    5041
    0 [2]
    Units: Subjects
    1328
    355
    Notes
    [2] - Per the protocol, no AE data were collected for this group during this time frame.
    No statistical analyses for this end point

    Primary: SSA: Number of Subjects Reporting Serious Adverse Events

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    End point title
    		 SSA: Number of Subjects Reporting Serious Adverse Events [3]
    End point description
    An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalisation or prolongation of existing hospitalisation; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as 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
    From booster dose to 6 months after booster dose and from 6 months after BNT162 vaccine for subjects who originally received placebo
    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 analysis was planned for this endpoint.
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo Placebo
    Number of subjects analysed
    5080
    5041
    4429
    Units: Subjects
    73
    42
    45
    No statistical analyses for this end point

    Secondary: SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population

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    End point title
    		 SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population
    End point description
    Occurrence of first severe COVID-19 infection based on FDA definition after booster dose without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate greater than or equal to [≥]30 breaths per minute, heart rate ≥125 beats per minute, oxygen saturation less than or equal to [≤]93% on room air at sea level, or Horovitz quotient <300 mm Hg); 2) respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic blood pressure [BP] <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death. Evaluable efficacy population assessed. Here, 'N'=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 7 Days after booster vaccination
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4689
    4664
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    1.105
    0.951
    Statistical analysis title
    		 BNT162b2 30 μg versus Placebo
    Comparison groups
    BNT162b2 30 microgram (mcg) v Placebo
    Number of subjects included in analysis
    9353
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Surveillance Time
    Point estimate
    100
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -358.6
         upper limit
    		 100

    Secondary: SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population

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    End point title
    		 SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population
    End point description
    Occurrence of first severe COVID-19 infection based on FDA definition after booster dose with and without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, oxygen saturation ≤93% on room air at sea level, or Horovitz quotient <300 mm Hg); 2) respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic BP <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death. Evaluable efficacy population assessed. Here, 'N'=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 7 Days after booster vaccination
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4977
    4942
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    1.182
    1.011
    Statistical analysis title
    		 BNT162b2 30 μg versus Placebo
    Statistical analysis description
    2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.
    Comparison groups
    BNT162b2 30 microgram (mcg) v Placebo
    Number of subjects included in analysis
    9919
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted Surveillance Time
    Point estimate
    100
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -355.5
         upper limit
    		 100

    Secondary: SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection

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    End point title
    		 SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection
    End point description
    Occurrence of first severe COVID-19 infection based on CDC definition after booster dose without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 and presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death. Evaluable efficacy population included eligible randomized subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 7 Days after booster vaccination
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4689
    4664
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection

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    End point title
    		 SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection
    End point description
    Occurrence of first severe COVID-19 infection based on CDC definition after booster dose with and without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 AND presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death. Evaluable efficacy population included eligible randomized subjects who received the booster vaccination as randomised and had no other important protocol deviations as determined by the clinician. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 7 Days after booster vaccination
    End point values
    		 BNT162b2 30 microgram (mcg) Placebo
    Number of subjects analysed
    4977
    4942
    Units: Surveillance time per 1000 person-years
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Death and SAEs: up to 6 months after booster dose (or 6 months after BNT162 vaccine for subjects originally receiving placebo); Non-serious AEs: up to 1 month after booster dose (or 1 month after BNT162 vaccine for subjects originally receiving placebo)
    Adverse event reporting additional description
    Same event may appear as both AE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both AE and non-SAE.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v25.0
    Reporting groups
    Reporting group title
    BNT162b2 30 microgram
    Reporting group description
    		 Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

    Reporting group title
    Original Placebo/BNT162b2 (30 microgram)
    Reporting group description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (normal saline solution of 0.9 percent [%] sodium chloride) intramuscularly.

    Serious adverse events
    		 BNT162b2 30 microgram Original Placebo/BNT162b2 (30 microgram) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    73 / 5080 (1.44%)
    45 / 4429 (1.02%)
    42 / 5041 (0.83%)
         number of deaths (all causes)
    5
    5
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenocortical carcinoma
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system neoplasm
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage II
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    2 / 5080 (0.04%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer metastatic
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic adenoma
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary neoplasm
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the vagina
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    3 / 5080 (0.06%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenoma
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penetrating aortic ulcer
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion incomplete
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    2 / 5080 (0.04%)
    1 / 4429 (0.02%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion complete
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Death
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    3 / 5041 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 5080 (0.02%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 5080 (0.02%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 5080 (0.04%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stoma complication
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    3 / 5080 (0.06%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 5080 (0.04%)
    1 / 4429 (0.02%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 5080 (0.06%)
    2 / 4429 (0.05%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myopericarditis
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial aneurysm
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 5080 (0.04%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    3 / 5080 (0.06%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic leukoencephalopathy
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric fistula
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 5080 (0.02%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 5080 (0.02%)
    2 / 4429 (0.05%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Vitiligo
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    3 / 5080 (0.06%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 5080 (0.00%)
    2 / 4429 (0.05%)
    2 / 5041 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 5080 (0.02%)
    4 / 4429 (0.09%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc space narrowing
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired immunodeficiency syndrome
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 5080 (0.06%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 5080 (0.02%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 5080 (0.02%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 5080 (0.02%)
    2 / 4429 (0.05%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Peritonitis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 5080 (0.00%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypervolaemia
         subjects affected / exposed
    1 / 5080 (0.02%)
    0 / 4429 (0.00%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 5080 (0.00%)
    1 / 4429 (0.02%)
    0 / 5041 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 BNT162b2 30 microgram Original Placebo/BNT162b2 (30 microgram) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1201 / 5080 (23.64%)
    771 / 4429 (17.41%)
    202 / 5041 (4.01%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    267 / 5080 (5.26%)
    144 / 4429 (3.25%)
    54 / 5041 (1.07%)
         occurrences all number
    269
    144
    54
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    383 / 5080 (7.54%)
    228 / 4429 (5.15%)
    66 / 5041 (1.31%)
         occurrences all number
    383
    228
    66
    Chills
         subjects affected / exposed
    243 / 5080 (4.78%)
    107 / 4429 (2.42%)
    11 / 5041 (0.22%)
         occurrences all number
    243
    107
    11
    Pyrexia
         subjects affected / exposed
    258 / 5080 (5.08%)
    142 / 4429 (3.21%)
    8 / 5041 (0.16%)
         occurrences all number
    258
    143
    8
    Pain
         subjects affected / exposed
    139 / 5080 (2.74%)
    122 / 4429 (2.75%)
    16 / 5041 (0.32%)
         occurrences all number
    140
    122
    16
    Injection site pain
         subjects affected / exposed
    673 / 5080 (13.25%)
    412 / 4429 (9.30%)
    83 / 5041 (1.65%)
         occurrences all number
    675
    412
    83
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    141 / 5080 (2.78%)
    59 / 4429 (1.33%)
    3 / 5041 (0.06%)
         occurrences all number
    147
    59
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    54 / 5080 (1.06%)
    0 / 4429 (0.00%)
    16 / 5041 (0.32%)
         occurrences all number
    54
    0
    16
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    58 / 5080 (1.14%)
    0 / 4429 (0.00%)
    1 / 5041 (0.02%)
         occurrences all number
    58
    0
    1
    Myalgia
         subjects affected / exposed
    248 / 5080 (4.88%)
    118 / 4429 (2.66%)
    21 / 5041 (0.42%)
         occurrences all number
    248
    119
    21

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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