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Good Clinical Practice (GCP) statement: The study was conducted according to GCP guidelines, the applic able local laws, and in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki.
Confidentiality statement : The information contained in this document is the property and copyright of BioNTech SE. Therefore, this 
document is provided in confidence to the recipient. No informa tion contained herein shall be published, disclosed or reproduc ed without 
prior written approval  of the pr oprietor.
1 TITLE PAGE
INTERIM CLINICAL STUDY REPORT - BNT162-01
Version: 3.0 Date of this report: 20 MAR 2021
Sponsor: BioNTech SE Date of previous reports 23 SEP 2020 (ver. 1.0)
55131 Mainz, Germany 28 NOV 2020 (ver. 2.0)
Title of study A multi-site, Phase I/II, 2-par t, dose-escalation trial investi gating the safety and 
immunogenicity of four prophylactic SARS -CoV-2 RNA vaccines against 
COVID -19 using different dosing regimens in healthy and 
immunocompromised adults
Study number BNT162-01
Protocol version Version 9.0 (dated 05 OCT 2020); the version valid at the 23 OCT 20 20
reactogenicity, safety, disposition, and immunogenicity data cut -off
Study design Multi-site, Phase I/II, dose-escalation and expansion study
Regulatory identifiers EudraCT no.: 2020-001038-36; Cli nicalTrials.gov: NCT04380701; WH O UTN: 
U1111-1249-4220
Investigational medicinal 
products (IMPs)BNT162: SARS-CoV-2 - RNA lipid nano particle (RNA-LNP) vaccines ut ilizing 
different RNA formats, i.e., BNT162b1 and BNT162b2
Indication Protection against COVID-19 caused by the SARS-CoV-2 virus
Phase of development I/II
Sponsor signatories Elizabeth Adams, MD, Senior Medi cal Director, BioNTech US, Inc.
Stefan Liebscher, Responsible Statistician
Coordinating 
investigatorDr. Dr. med. Armin Schultz, CRS Clinical Research Services 
Mannheim GmbH, Germany
Study sites Sites in Berlin and Mannheim, Germany.
For further details of the study sites and site personnel, see Appendix 16.1.4 .
Study period Study start / end date: 23 APR 2020 / Ongoing
Early study termination: Not applicable
Type of report Interim report (the BNT162-01 study is clinically ongoing; see t he below notes)
This clinical study is still clinically ongoing. This third interim clinical study report (CSR) summarizes reactogenicity and 
safety data available for BNT162b1 and BNT162b2 collected up until Visit 8 (t he first follow-up visit at ~63 d after the 
second dose) for dose-escalation and dose-expansion cohorts (dose groups) in P art A of this study, therefore this CSR 
only describes the study conduct relevant for these dose groups. This CSR differs from the second interim CSR in that 
additional cell-mediated immunity (CMI) data were added for a small number o f participants that received 10, 20, and 
30μg BNT162b2 using research samples collected at Visit 8 (63 d post- Dose 2) and Visit 9 (162 d post-Dose 2).
The respective data cut-off dates ar e: reactogenicity, safety, dispo sition, and immunogenicity data (23 OCT 2020); T -
cell response data (ELISpot data) data ( 02 MAR 2021); intracellular cytokine staining (ICS) data (17 NOV 20 20 for 
BNT162b1 and 0 2 MAR 2021 for BNT162b2).
The data from this study, together with data from other sources including  the study BNT162-02/C4591001, were used 
to select the BNT162 vaccine and dose level for further study in the Phase II/III evaluation of efficacy.
Data not included here will be provided in later interim reports and/or the final CSR, which will include data for the other 
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 Blinding and unblinding 24 
 Prior and concomitant medication 24 
 Treatment compliance 24 
 Genetic, biomarker, immunogenicity, and safety variables 24 
 Study assessments and schedule of events 24 
 Demography and other baseline characteristics 28 
 Genetics, biomarkers, and immunogenicity assessments 28 
 Safety assessments 28 
 Appropriateness of measurements 28 
 Data quality assurance 28 
 Site selection, clinical monitoring, and site performance 28 
 Assessment of CRO performance 29 
 Data quality control procedures 29 
 Data documentation and archiving 29 
 Audit procedures 29 
 Statistical methods and determination of sample size 29 
 Statistical and analytical plans 29 
 Sample size rationale 33 
 Data available for this interim report 33 
 Changes in the conduct of the study or planned analyses 35 
 Changes in the conduct of the study 35 
 Changes in the planned analyses 35 
10 STUDY PARTICIPANTS 36 
 Disposition of participants 36 
 BNT162b1 36 
 BNT162b2 39 
 Protocol deviations (investigator-reported) 42 
 Unblinding of single participants 42 
 Data sets analyzed 42 
 Datasets –Reactogenicity and safety 42  
 Datasets –Immunogenicity assessments 45  
 Datasets –CMI assessments 45  
 Demographic and other baseline characteristics 46 
 BNT162b1 46 
 BNT162b2 48 
 Prior and concomitant medication 50 
 Medical history 50 
 Measurement of treatment compliance 51 090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT )
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11 IMMUNOGENICITY, CELL-MEDIATED IMMUNE RESPONSE, AND 
GENETICS RESULTS 52  
 Immunogenicity –functional antibody responses (secondary objective) 52  
 Immunogenicity –binding antibody concentrations (exploratory objective) 57  
 Cell-mediated immune responses 60 
 SARS-CoV-2-specific CD4+and CD8+T-cell responses 60 
 Functional and pro-inflammatory CD4+/CD8+T-cell responses 63 
 Genetics 69 
12 SAFETY EVALUATION 70 
 Extent of exposure 70 
 Primary safety endpoints 70 
 BNT162b1 70 
 BNT162b2 72 
 Solicited local reactions 74 
 Solicited local reactions within 7 d after each BNT162b1 dose 74 
 Local reactions by severity –BNT162b1 75  
 Time to onset and duration of local reactions –BNT162b1 78  
 Solicited local reactions within 7 d after each BNT162b2 dose 79 
 Local reactions by severity –BNT162b2 80  
 Time to onset and duration of local reactions –BNT162b2 83  
 Solicited systemic reactions 84 
 Solicited systemic reactions within 7 d after each BNT162b1 dose 84 
 Solicited systemic reactions by severity –BNT162b1 86  
 Time to onset and duration of systemic reactions –BNT162b1 89  
 Solicited systemic reactions within 7 d after each BNT162b2 dose 90 
 Solicited systemic reactions by severity –BNT162b2 92  
 Time to onset and duration of systemic reactions –BNT162b2 97  
 Adverse events 98 
 Overview of adverse events 98 
 Analysis of adverse events 108  
 Listing of AEs by participant 116  
 Deaths, other SAEs, and other significant AEs 117  
 BNT162b1 117  
 BNT162b2 118  
 Clinical laboratory evaluation 119  
 Listing of individual laboratory measurements by participant and  each abnormal 
laboratory value 119  
 Evaluation of each laboratory parameter 119  090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT )
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 Individual clinically relevant abnormalities in clinical labora tory values 124  
 Vital signs, physical findings, and other observations related to safety 124  
 Vital signs 124  
 12-lead electrocardiograms 125  
 Physical examination 125  
 Pregnancy 125  
 Safety conclusions 125  
 BNT162b1 125  
 BNT162b2 126  
13 DISCUSSION AND OVERALL CONCLUSIONS 128  
 Safety 128  
 Immunogenicity (antibody responses) 130  
 Cell-mediated immune responses 132  
 Overall conclusions 133  
14 TABLES AND FIGURES 135  
15 REFERENCES 140  
16 APPENDICES 141  
LIST OF IN-TEXT TABLES
Table 1:  Characteristics of BNT162b1 and BNT162b2 17 
Table 2:  Schedule of study procedures and assessments for BNT162b1 and 
BNT162b2 25  
Table 3:  Summary of the coded reasons for these protocol deviations 42 
Table 4:  Analysis sets –BNT162b1 Younger participants (SAF) 43  
Table 5:  Analysis sets –BNT162b1 Older participants and all participants (SAF) 43  
Table 6:  Analysis sets –BNT162b2 Younger participants (SAF) 44  
Table 7:  Analysis sets –BNT162b2 Older participants and all participants (SAF) 44  
Table 8:  Immunogenicity analysis sets 45 
Table 9:  CMI analysis sets 46 
Table 10:  Descriptive statistics for demographic parameters –BNT162b1 younger 
participants (SAF) 47  
Table 11:  Descriptive statistics for demographic parameters –BNT162b1 older 
participants and all participants (SAF) 48  
Table 12:  Descriptive statistics for demographic parameters –BNT162b2 younger 
participants (SAF) 49  
Table 13:  Descriptive statistics for demographic parameters –BNT162b2 older 
participants and all participants (SAF) 50  
Table 14:  IMP compliance –BNT162b1 (SAF) 51  090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT )
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Table 15:  IMP compliance –BNT162b2 (SAF) 51  
Table 16:  Extent of exposure to BNT162b1 and BNT162b2 70 
Table 17:  An overview of primary endpoint –BNT162b1 (SAF) 71  
Table 18:  An overview of primary endpoint –BNT162b2 (SAF) 73  
Table 19:  Summary of solicited local reactions –BNT162b1 (SAF) 75  
Table 20:  Frequency of participants with solicited local reactions by grade –BNT162b1 
(Combined interval –SAF) 77  
Table 21:  Summary of solicited local reactions –BNT162b2 (SAF) 80  
Table 22:  Frequency of participants with solicited local reactions by grade –BNT162b2 
(Combined interval –SAF) 82  
Table 23:  Summary of solicited systemic reactions –BNT162b1 (SAF) 85  
Table 24:  Frequency of participants with solicited systemic reactions by grade –
BNT162b1 (Combined interval) younger participants (SAF) 87  
Table 25:  Frequency of participants with solicited systemic reactions by grade –
BNT162b1 (Combined interval) older participants and all participants (SAF) 88  
Table 26:  Summary of solicited systemic reactions –BNT162b2 (SAF) 92  
Table 27:  Frequency of participants with solicited systemic reactions by grade for –
BNT162b2 (Combined interval) younger participants (SAF) 95 
Table 28:  Frequency of participants with solicited systemic reactions by grade for –
BNT162b2 (combined interval) older participants and all partici pants (SAF) 96  
Table 29:  Summary of TEAEs without AEs based on solicited reporting via d iaries –
BNT162b1 –Younger participants (SAF) 100  
Table 30:  Summary of TEAEs without AEs based on solicited reporting via d iaries –
BNT162b1 –Younger participants (SAFB) 101  
Table 31:  Summary of TEAEs without AEs based on solicited reporting via d iaries –
BNT162b1 older participants and all participants (SAF) 102  
Table 32:  Summary of TEAEs without AEs based on solicited reporting via d iaries –
BNT162b1 older participants and all participants (SAFB) 103  
Table 33:  Summary of TEAEs without AEs based on solicited reporting via d iaries –
BNT162b2 –Younger participants (SAF) 105  
Table 34:  Summary of TEAEs without AEs based on solicited reporting via d iaries –
BNT162b2 –Older participants and all participants (SAF) 107  
Table 35:  Frequency of participants with TEAEs without AEs based on solic ited reporting 
via diaries by SOC and PT –BNT162b1 younger participants (SAF) 109  
Table 36:  Frequency of participants with TEAEs without AEs based on solicited reporting 
via diaries by SOC and PT –BNT162b1 older participants and all participants 
(SAF) 111  
Table 37:  Frequency of participants with TEAEs without AEs based on solicited reporting via diaries by SOC and PT –BNT162b2 younger participants (SAF) 112
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Table 38:  Frequency of participants with TEAEs without AEs based on solic ited reporting 
via diaries by SOC and PT –BNT162b2 –Older participants and all participants 
(SAF) 114  
Table 39:  Laboratory: Descriptive statistics, continuous (Hematology) –BNT162b1 
(SAF) 120  
Table 40:  Laboratory: Descriptive statistics, continuous (Hematology) –BNT162b2 
(SAF) 122  
Table 41:  Overview of primary endpoint by age group 130  
LIST OF IN-TEXT FIGURES
Figure 2:  Disposition of younger participants –BNT162b1 37  
Figure 3:  Disposition of older participants –BNT162b1 38  
Figure 4:  Disposition of younger participants –BNT162b2 40  
Figure 5:  Disposition of older participants –BNT162b2 41  
Figure 6:  BNT162b1 –Functional 50% SARS-CoV-2 neutralizing antibody titers (VN 50)–
IMM 52 
Figure 7:  BNT162b2 –Functional 50% SARS-CoV-2 neutralizing antibody titers (VN 50)–
IMM 53 
Figure 8:  BNT162b1 –Fold increase from baseline in functional 50% SARS-CoV-2
neutralizing antibody titers (VN 50)–IMM 54  
Figure 9:  BNT162b2 –Fold increase from baseline in functional 50% SARS-CoV-2
neutralizing antibody titers (VN 50)–IMM 54  
Figure 10:  BNT162b1 –Frequency of participants with  SARS-CoV-2 GMT seroconversion 
–IMM 56  
Figure 11:  BNT162b2 –Frequency of participants with  SARS-CoV-2 GMT seroconversion 
–IMM 56  
Figure 12:  BNT162b1 –Fold increase from baseline in S1-binding antibody concentratio ns 
–IMM 57  
Figure 13:  BNT162b2 –Fold increase from baseline in S1-binding antibody concentratio ns 
–IMM 58  
Figure 14:  BNT162b1 –Frequency of participants with S1-binding IgG GMC 
seroconversion –IMM 59  
Figure 15:  BNT162b2 –Frequency of participants with S1-binding IgG GMC 
seroconversion –IMM 59  
Figure 16:  Durability of BNT162b2-induced T-cell responses 62 
Figure 17:  S-specific CD4+T-cells producing the indicated cytokines in response to 
S protein pool 1 as a fraction of total cytokine-producing S-spe cific CD4+Tc e l l s  
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Figure 18:  S-specific CD4+T-cells producing the indicated cytokines in response to 
S protein pool 1 as a fraction of total cytokine-producing S-spe cific CD4+Tc e l l s  
(10 to 30 μg BNT162b2 older participant dose groups) 66  
Figure 19:  Persistence of S-specific CD4+and CD8+T cells producing the indicated 
cytokines (IFN Jand IL-2) as a fraction of total circulating CD4+and CD8+Tc e l l s  
(30 μg BNT162b2 dose group in younger and older participants) 68  
LIST OF APPENDICES
16.1 Study information
16.1.1 Protocol and protocol amendments
16.1.1.1 Protocol incl. amendments 01 to 06
Clinical study protocol incl. amendments 01 to 06
16.1.1.2 Informed consent forms
Participant information leaflet and declaration of consent
Participant information leaflet and declaration of consent –Additional blood sampling: 
ImmunomonitoringParticipant information leaflet and declaration of consent –Additional blood sampling: 
Pharmacogenomic testing HLA
16.1.1.3 Protocol amendment history incl. amendments 01 to 06
Clinical study protocol amendment history including amendments 0 1 to 06
16.1.1.4 Manuals
Pharmacy manual
Appendix to the pharmacy manual
Laboratory manual
Biomarker manual
16.1.2 Sample case report form
Sample case report form
16.1.3 List of IECs
16.1.4 List of investigators and description of investigators an d other important 
participants contributing to the study
16.1.4.1 List of investigators
16.1.4.2 Brief curriculum vita for all investigators and other i mportant participants
Curriculum vitae Baumann
Curriculum vitae Berse
Curriculum vitae Casjens
Curriculum vitae Schultz
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16.1.4.3 List of providers
16.1.5 Signatures of coordinating investigator and sponsor signa tories
Coordinating investigator’s signature
Sponsor signatures
16.1.6 Listing of participants receiving test drugs/investigationa l products from specific 
batches
BNT162-01 batch-b1BNT162-01 batch-b2
16.1.7 Randomization scheme and codes (participant identificatio n and treatment 
assigned) –(Not applicable)
16.1.8 Audit certificates (Not available)
16.1.9 Documentation of statistical methods
Statistical analysis plan
16.1.10 Documentation of inter-laboratory standardization method s and quality 
assurance procedures (Not applicable)
16.1.11 Publications based on the study (Not applicable)16.1.12 Important publications referenced in the report
Mulligan M et al. 2020  
Walsh E et al. 2020
16.1.13 List of sponsor personnel who materially affected the st udy conduct
16.1.14 R&D Study reports
R-20-0253 - Neutralizing antibody titer and SARS-COV-2 S1- and RBD -specific 
antibody concentration  in serum from participants in the BNT162 -01 trial
GA-RB-022-01A - T cell immune monit oring (TCIM) of study participants in the 
BNT162-01 clinical trial - GC(L)P analytical study interim report
R-20-0235 - Analysis of the Th1/2 cytokine profile of BNT162b1-sp ecific CD4 and CD8 
T cells (interim report for 95 subjects)
R-20-0241 - Analysis of the Th1/2 cytokine profile of BNT162b2-sp ecific CD4 and CD8 
T cells (interim report for 74 subjects)
R-20-0244 - Ex vivo ELISpot data processing and analysis within BNT162-01 clinical 
trial
16.2 Participant data listingsNote to reader
General considerations BNT162b1
General considerations BNT162b216.2.1 Disposition and baseline characteristics
Listing 16.2.1-1-1: Listing o f subject disposition - BNT162b1
Listing 16.2.1-1-3: Listing o f subject disposition - BNT162b2090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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Listing 16.2.1-2-1: Listing of protocol deviations - BNT162b1
Listing 16.2.1-2-3: Listing of protocol deviations - BNT162b2
Listing 16.2.1-3-1: Listing of s ubjects with premature disconti nuation - BNT162b1
Listing 16.2.1-3-3: Listing of s ubjects with premature disconti nuation - BNT162b2
16.2.1-4 Subjects excluded from analysis sets
Listing 16.2.1-4.1-1: Listing of subjects´ inclusion in analysi s sets - BNT162b1
Listing 16.2.1-4.1-3: Listing o f subjects´ inclusion in analysi s sets - BNT162b2
Listing 16.2.1-4.2-1: Listing of subjects excluded from Safety Boost Set - BNT162b1
Listing 16.2.1-4.2-3: Listing of subjects excluded from Safety Boost Set - BNT162b2
Listing 16.2.1-4.3-1: Listing of subjects excluded from Immunog enicity Set - BNT162b1
Listing 16.2.1-4.3-3: Listing of subjects excluded from Immunog enicity Set - BNT162b2
Listing 16.2.1-5-1: Listing of subject demographics - BNT162b1Listing 16.2.1-5-3: Listing of subject demographics - BNT162b2
16.2.1-6 Prior and concomitant medication
Listing 16.2.1-6.1-1: Listing of prior medication - BNT162b1
Listing 16.2.1-6.1-3: Listing of prior medication - BNT162b2
Listing 16.2.1-6.2-1: Listing of concomitant medication - BNT162 b1
Listing 16.2.1-6.2-3: Listing of concomitant medication - BNT162 b2
Listing 16.2.1-7-1: Listing of medical history - BNT162b1
Listing 16.2.1-7-3: Listing of medical history - BNT162b2
16.2.3 Safety
16.2.3-1 Primary endpoints
Listing 16.2.3-1.1-1: Listing of solicited local reactions - BNT 162b1
Listing 16.2.3-1.1-3: Listing of solicited local reactions - BNT 162b2
Listing 16.2.3-1.2-1: Listing of diary compliance local reactio ns - BNT162b1
Listing 16.2.3-1.2-3: Listing of diary compliance local reactio ns - BNT162b2
Listing 16.2.3-1.3-1: Listing of solicited systemic reactions - BNT162b1
Listing 16.2.3-1.3-3: Listing of solicited systemic reactions - BNT162b2
Listing 16.2.3-1.4-1: Listing of diary compliance systemic reac tions - BNT162b1
Listing 16.2.3-1.4-3: Listing of diary compliance systemic reac tions - BNT162b2
Listing 16.2.3-1.5-1: Listing of adverse events - BNT162b1
Listing 16.2.3-1.5-3: Listing of adverse events - BNT162b2Listing 16.2.3-1.6-1: Listing of adverse events without adverse  events based on 
solicited reporting via diaries - BNT162b1
Listing 16.2.3-1.6-3: Listing of adverse events without adverse  events based on 
solicited reporting via diaries - BNT162b2
16.2.3-2 Further safety endpoints
Listing 16.2.3-2.1-1: Listing of drug exposure - BNT162b1Listing 16.2.3-2.1-3: Listing of drug exposure - BNT162b2
Listing 16.2.3-2.2-1: Listing of laboratory measurements - BNT16 2b1090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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Listing 16.2.3-2.2-3: Listing of laboratory measurements - BNT16 2b2
Listing 16.2.3-2.3-1: Listing of vital signs - BNT162b1
Listing 16.2.3-2.3-3: Listing of vital signs - BNT162b2
Listing 16.2.3-2.9-1: Listing of SARS-CoV-2 testing - BNT162b1
Listing 16.2.3-2.9-3: Listing of SARS-CoV-2 testing - BNT162b2
Listing 16.2.3-2.10-1: Listing of comments - BNT162b1
Listing 16.2.3-2.10-3: Listing of comments - BNT162b2
16.3 Case report forms
16.3.1 CRFs of deaths, other SAEs and withdrawals for AEs (Available on request)16.3.2 Other CRFs submitted (Not applicable)
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5E T H I C S
Independent ethics committee (IEC)
The protocol (see Appendix 16.1.1.1 ) and the informed consent form (ICF) (see 
Appendix 16.1.1.2 ) were reviewed and approved by  the responsible IEC. The consulted 
IEC, including the name of the co mmittee chair, is provided in Appendix 16.1.3 .
This clinical study is still clinically ongoing. At the reactoge nicity, safety, disposition, and 
immunogenicity data cut-off for this CSR (23 OCT 2020), a total of six protocol 
amendments were issued, submitted to the IEC, and were approved  where applicable (for 
details, see the Protocol Amendment History provided in Appendix 16.1.1.3 ).
Ethical conduct of the study and regulatory approval
The study was conducted according to GCP guidelines, the applic able local laws, and in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki.
The competent authority, the German Paul-Ehrlich-Institut, appr oved the study as required 
by national regulations.
Participant inform ation and consent
The participation of the participants and the investigation of their eligibility were subject to 
informed consent. Only participants who were able and willing to consent freely to participate after receiving detai led information both verbally and in writing were eligible for 
enrollment.
Before the start of any study- related examination, an investiga tor or investigator’s delegate  
informed the participants about the nature, importance, implica tions, and risks of the study. 
The participants were informed about the study treatments, the method of administration, 
blood sampling, rules of conduct, and any restrictions that app lied. Possible effects and 
side effects of the study treatments were discussed. The extent  of the examinations to be 
performed and the invasive and noninvasive investigation method s were explained. The 
participants were given the opportunity to ask questions concer ning any and all aspects of 
the study. All participants were informed that participation wa s voluntary and that they 
could cease participation at any time without necessarily giving a reason and without any 
penalty or loss of benefits to which they were entitled. They h ad to be able to understand 
the full implications of their decision to participate in the s tudy.
Local ICFs were drawn up in German before the start of the study. A copy of the local ICFs were supplied to the IEC for approval.
All study participants signed the local ICF valid at the time o f their enrollment as proof of 
consent. Study participants were given a copy of the signed ICF s.
The ICFs supplied with this report ( Appendix 16.1.1.2 ) are English translations of the local 
ICFs (one each for the trial, additional blood draws for immuno genicity monitoring, and 
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6 INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
This study initially was sponsored by BioNTech RNA Pharmaceutic al GmbH and 
conducted clinically by CRS Clinical Research Services Mannheim  GmbH (the clinical 
CRO) at CRS sites in Berlin and Mannheim Germany. On the 04 DEC 2020, i.e., after the 
reactogenicity, safety, disposition, and immunogenicity data cut -off for this report, the 
study sponsor was changed to BioNTech SE.
Medical and clinical monitoring o f this study was conducted by the sponsor or its 
designated representatives.The study was conducted by CRS investigators under the direction  of the sponsor. The 
investigators were responsible for adhering to the study procedures described in the 
protocol, for keeping records of the study interventions, and f or ensuring accurate 
completion of the CRFs and data c ollection tools supplied by th e sponsor.
Medical investigators and investigative sites
A list of the investigators that includes their affiliation and  their role in the study is provided 
inAppendix 16.1.4 . The documentation, e.g., curriculum vitae, of the qualificati ons of the 
investigators and other site personnel is held in the trial mas ter file (TMF). The signature of 
the coordinating investigator is provided in Appendix 16.1.5 .
External suppliers and CROs
A list of external suppliers and CROs is provided in Appendix 16.1.4.
Sponsor’s personnel
A list of persons employed by the sponsor whose participation m aterially affected the 
conduct of the study is provided in Appendix 16.1.4 . Documentation of the qualifications of 
these personnel is held in the sponsor’s records. Signatures of the sponsor signatories are
provided in Appendix 16.1.5 .
Insurance
No-fault insurance coverage for the study participants was arra nged with insurance 
companies in accordance with local requirements. Relevant docum entation is maintained 
in the TMF. Before the start of th e study, the study participant s were informed by the 
investigator about the existence of this insurance coverage.
Committees
This study has a Safety Review Committee (SRC) to monitor study  participant safety 
during the study. SRC tasks include confirming IMP doses before  use, advising regarding 
appropriate safety measures (e.g., prolongation of post-dose on site observation periods), 
monitoring (and if required stopping) study participant dosing within a dose group or 
stopping administration of Dose 2. For further details of SRC tas ks and membership, see 
Protocol Section 10.1.5 . Documentation of the data reviewed and outcomes are filed in the 
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9 INVESTIGATIONAL PLAN
Descriptions of any deviations from the protocol, any changes in the conduct of the study,
and any changes in the planned analyses are given in Section 9.12.
Overall study d esign and plan –description
The study design is described in detail in Protocol Section 4.1 .
An overall description of the study is presented in the flow di agram in Figure 1 .
A schedule of events is given in Table 2 .
A sample CRF is included in Appendix 16.1.2 .
Discussion of study design
A discussion of the study design is provided in Protocol Section 4.2 .
Selection of study population
Study participants were selected from the volunteer panel at the  clinical CRO, volunteers 
who responded to either generic or study-specific advertisements in social media, or 
volunteers who contacted the clinical CRO via a web-based study participant recruitment 
portal. Study participants were selected from this pool of volunteers according to inclusion 
and exclusion criteria given in Sections 9.4and9.5.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, were not permitted.
Inclusion criteria Part A
Volunteers were only enrolled in the study if they met all of the following criteria:
1. Have given informed consent by signing the ICF before initiat ion of any study-
specific procedures.
2. They must be willing and able to comply with scheduled visits , treatment schedule, 
laboratory tests, lifestyle restrictions (e.g., to practice soc ial distancing and to follow 
good practices to reduce their chances of being infected or spr eading COVID-19), 
and other requirements of the study.
3. They must be able to understand and follow study-related instructions.
4. For younger participant dose groups, volunteers must be aged 1 8 to 55 yrs, have a 
BMI over 19 kg/m2and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
ORFor older adult dose groups, volunteers must be aged 56 to 85 yr s, have a BMI over 
19 kg/m
2and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
5. They must be healthy, in the clinical judgment of the investi gator, based on medical 
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pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests 
(blood chemistry, hematology, and urine chemistry) at Visit 0.
Note: Healthy volunteers with pre -existing stable disease, defi ned as disease not 
requiring significant change in therapy or hospitalization for w orsening disease 
during the 6 wks before enrollment, can be included.
6. Women of childbearing potential (WOCBP) must have a negative beta-human 
chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are 
postmenopausal or permanently sterilized will be considered as not having reproductive potential.
7. WOCBP must agree to practice a highly effective form of contr aception during the 
study, starting after Visit 0 and continuously until 60 d after r eceiving the last IMP
dose. WOCBP must agree to require their male partners to use co ndoms during 
sexual contact (unless male partners are sterilized or infertil e).
8. WOCBP must confirm that they practiced at least one highly ef fective form of 
contraception for the 14 d prior to Visit 0.
9. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during study, starting after Visit 0 and continuous ly until 60 d after 
receiving the last IMP dose.
10. Men who are sexually active with a WOCBP and have not had a vasectomy must 
agree to practice a highly effective form of contraception with  their female partner of 
childbearing potential during the study, starting after Visit 0 and continuously until 60 d after receiving the last IMP dose.
11. Men must be willing to refrain from sperm donation, starting  after Visit 0 and 
continuously until 60 d after receiving the last IMP dose.
12. They must have confirmation of their health insurance covera ge prior to Visit 0.
13. They must agree to not be vaccinated during the study, starting after Visit 0 and 
continuously until 28 d after receiving the last IMP dose.
Exclusion criteria Part A
Volunteers were excluded from the study if they meet or present any of the following criteria:
1. Have had any acute illness, as determined by the investigator , with or without fever, 
within 72 h prior to the first immunization. An acute illness wh ich is nearly resolved 
with only minor residual sympt oms remaining is allowable if, in  the opinion of the 
investigator, the residual symptoms will not compromise their w ellbeing if they 
participate as study participants in the study, or that could prevent, limit, or confound the protocol-specified assessments.
2. Are breastfeeding on the day of Visit 0 or who plan to breastf eed during the study,
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3. Have a known allergy, hypersensitivity, or intolerance to the planned IMP including 
any excipients of the IMP.
4. Had any medical condition or any major surgery (e.g., requiri ng general anesthesia) 
within the past 5 yrs which, in the opinion of the investigator, could compromise their 
wellbeing if they participate as study participants in the study, or that could prevent, 
limit, or confound the protocol-specified assessments.
5. Have any surgery planned during the study, starting after Vis it 0 and continuously 
until at least 90 d after receiving the last IMP dose.
6. Had any chronic use (more than 21 continuous days) of any systemic medications, 
including immunosuppressant’s or other immune -modifying drugs, within the 
6 months prior to Visit 0 unless in the opinion of the investigator, the medication 
would not prevent, limit, or confound the protocol-specified as sessments or could 
compromise participant safety.Note: Healthy participants with  pre-existing stable disease, def ined as disease not 
requiring significant change in therapy or hospitalization for w orsening disease 
during the 6 wks before enrollment, can be included.
7. Received any vaccination within the 28 d prior to Visit 0.
8. Had administration of any immunoglobulins and/or any blood products within the 
3 months prior to Visit 0.
9. Had administration of another investigational medicinal product including vaccines 
within 60 d or five half-lives (whichever is longer), prior to Vi sit 0.
10. Have a known history or a pos itive test of any of HIV 1 or 2, Hepatitis B, or 
Hepatitis C, within the 30 d prior to Visit 0.
11. Have a positive PCR-based test for SARS-CoV-2 within the 30 d  prior to Visit 1.
12. Have a positive drugs of abuse (for amphetamines, benzodiaze pines, barbiturates, 
cocaine, cannabinoids, opiates, methadone, methamphetamines, ph encyclidine, and 
tricyclic antidepressants) result at Visit 0 or Visit 1.
13. Have a positive breath alcoho l test at Visit 0 or Visit 1.
14. Previously participated in an investigational study involving  lipid nanoparticles.
15. Are subject to exclusion periods from other investigational studies or simultaneous 
participation in another clinical study. When entering the follo w-up phase, i.e., after 
completing the EoT visit, subjec ts are allowed to participate in other clinical trials not 
investigating COVID-19 vaccines or treatments.
16. Have any affiliation with the study site (e.g., are close rel ative of the investigator or 
dependent person, such as an employee or student of the study si te).
17. Have a history (within the past 5 yrs) of substance abuse or known medical, 
psychological, or social conditions which, in the opinion of the  investigator, could 
compromise their wellbeing if they participate as study participa nts in the study, or 
that could prevent, limit, or confound the protocol-specified a ssessments.
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19. Have a history of Guillain-Barré syndrome within 6 wks follow ing a previous 
vaccination.
20. Have a history of narcolepsy.
21. Have history of alcohol abuse or drug addiction within 1 yr be fore Visit 0.
22. Have a history of or suspected immunosuppressive condition, acquired or 
congenital, as determined by medi cal history and/or physical ex amination at Visit 0.
23. Have any abnormality or permanent body art (e.g., tattoo) th at, in the opinion of the 
investigator, would obstruct the ability to observe local react ions at the injection site.
24. Have had any blood loss >450 mL, e.g., due to donation of blo od or blood products 
or injury, within the 7 d prior to Visit 0 or plan to donate bloo d during the study,
starting after Visit 0 and continuously until at least 7 d after receiving the last IMP
dose.
25. Symptoms of COVID-19, e.g., respiratory symptoms, fever, coug h, shortness of 
breath and breathing difficulties.
26. Have had contact with persons diagnosed with COVID-19 or who tested positive for 
SARS-CoV-2 by any diagnostic test within the 30 d prior to Visit 1.
27. Are soldiers, are in detention, are CRO or sponsor staff or t heir family members.
28. Regular receipt of inhaled/nebulized corticosteroids.
29. For older adults only: Have a condition known to put them at  high risk for severe 
COVID-19, including those with any of the following risk factor s:
−Hypertension
−Diabetes mellitus
−Chronic obstructive pulmonary disease
−Asthma
−Chronic liver disease
−Known Stage 3 or worse chronic kidney disease (glomerular filtration rate 
<60 mL/min/1.73 m2)
−Serious heart conditions, such as heart failure, coronary arter y disease, or 
cardiomyopathies
−Sickle cell disease
−Cancer
−Are immune compromised due to stem cell or organ-transplantatio n with 
significant medical complication s such as acute or chronic graft  rejection or 
graft versus host disease requir ing intensive immunosuppressive  treatment, 
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−Are immune compromised due to HIV  infection with a CD4+ count o f < 200 x 
106 /L at screening or significant medical complications such a s opportunistic 
infections, malignant complications (e.g., lymphoma, Kaposi sar coma), other 
organ manifestations consistent with advanced AIDS or other conditions that 
would be considered a contraindication for vaccination
−Resident in a long-term facility
−Current vaping or smoking (occasional smoking is acceptable)
−History of chronic smoking within the prior year
Removal of participants from the study, study assessments or 
IMP
Criteria for study participant discontinuation from the study o r IMP are listed in Protocol 
Section 7 . The handling of study participant discontinuation from the st udy or IMP is 
described in Protocol Section 7 .
Treatments
Treatments administered
The administration of study treatments is described in detail in Protocol Section 6 .
Investigational medicinal products
Name: BNT162 vaccines - Antiviral RNA v accines for active immunization  against 
COVID-19.
IMP and dose 
levels:Younger participants aged 18 to 55 yrs:
BNT162b1: 1 μg, 3 μg, 10 μg, 20 μg, 3 0 μg, 50 μg, and 60 μg.
BNT162b2: 1 μg, 3 μg, 10 μg, 20 μg, 30 μg.
Older participants aged 56 to 85 yrs:
BNT162b1: 10 μg, 20 μg, and 30 μg.
BNT162b2: 10 μg, 20 μg, and 30 μg.
Dosing 
regimen:Two injections ~21 d apart. Injection volumes were up to 0.5 mL.
Dosing route: IM; upper arm, musculus deltoideus . Use of the same arm for both doses was 
allowed. The non-dominant arm was preferred.
Batch Nr.: BNT162b1: E220195-0001L, E220195-0004L, E220195-0014L.
BNT162b2: E220195-0004L, E220195-0017L, E220195-0018L.
Packaging and labeling of the IMPs are described in the Pharmacy Manual and the 
connected appendix provided in Appendix 16.1.1.4 .
Instructions for delivery, storage, and disposal of IMP are desc ribed in the Pharmacy 
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A listing connecting the participants receiving each batch is p rovided in Appendix 16.1.6 .
Method of assignment to dose groups (allocation)
Study participants were not assig ned to the study dose groups a ccording to a 
randomization plan. Dose groups are groups of study participant s who receive the same 
IMP at the same dose level and who belong to the same age group , i.e., younger 
participants or older participants.
Selection of doses in the study
The rationale for the selection of doses for this study is prov ided in Protocol Section 4.3 .
During the study, the SRC is required to confirm or adapt the a cceptability of the planned 
IMP dose before use.
Selection and timing of dose for each participant
Study participants received IMP as described in Protocol Section 6.1 .
Blinding and unblinding
Not applicable because this is an open-label study.
Prior and concomitant medication
Allowed and forbidden concomitant medications are given in Protocol Section 6.5 .
Treatment compliance
The IMP was administered by  a physician as described in Protocol Section 6.1 .
Drug accountability requirements are specified in Protocol Section 6.2 .
Genetic, biomarker, immunogenicity, and safety variables
Study assessments and schedule of events
An overall description of the study is presented in the flow di agram in Figure 1 .
A schedule of events is given in Table 2 .
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a) Brief (symptom-directed) physical examination; no height meas urement.
b) At 1, 3, and 6 h (±15 min) after immunization.
c) Vital signs: systolic/diastolic blood pressure, pulse rate, r espiratory rate, and body temper ature; body weight only at Visi t0 .
d)Urine screening for drugs of abuse (amphetamines, benzodiazepin es, barbiturates, cocaine, cannabinoids, opiates, methadone, me thamphetamines, phencyclidine, tricyclic antidepressants).
e) Dipstick urine analysis. Microscopic urinalysis: if warranted  by dipstick results.
f) Clinical laboratory tests: chemistry and hematology. Only in wo men who are not WOCBP (to confirm postmenopausal status): folli cle stimulating hormone at Visit 0.
g) Viral screening for human immunodeficiency virus (HIV) 1 or 2 , hepatitis B, hepatitis C.
h) Flexibility for visit days: Visit 3 Day 8±1 d; Visit 4 Day 22±2 d;  Visit 5 Day 29±3 d; Visit 6 Day 43±4 d; Visit 7 Day 50±4 d; Visit 8 Day  85±7 d; Visit 9 Day 184±9d.
i) Only for the first six participants per group. Questioning on and documentation of AEs as well as systemic and local reaction s, the latter in case of upcoming dose decision meetings.
j) Only IMP-related AEs and any SAEs.
k) Blood draw for anti-SARS-CoV-2 antibodies (samples will be st ored until a test is commercially available).
l) For Dose Groups 1 and 8, immuni zation with at least 1 h interva ls between participants for the first six participants and then with of at least 30 min intervals for the remaining 6 participan ts. For all 
other dose groups, immunization with at least 15 min intervals b etween participants and for the boost injections.
m) Oral swipe for SARS-CoV-2 testin g either on Day -1 or at the V isit 1 on Day 1.
n) The listed blood draw days may be adapted if justified by the collected data. Leftover blood after completion of the immunog enicity assessments may be used for additional analyses as desc ribed in 
Protocol Section 8.7 (Genetics) and/or Protocol Section 8.8 (Biomarkers).
o) For participants who have given consent, one aliquot of the blood sample drawn for analysis of CMI may be used for HLA typin g to allow additional analysis of T-cell receptor repertoire and  / or 
phenotypic characterization of T cells specific to vaccine-encod ed antigens.
p) If HLA typing using the blood sample collected with Lithium H eparin is not conclusive, EDTA-blood will be drawn for HLA test ing.
q) Only dose groups with dose 1 after approval of protocol amendme nt 06.
r) When entering the follow-up phase, i.e., after completing the EoT visit, participants are allowed to participate in other cl inical studies not investigating COVID-19 vaccines or treatment s.
Notes: If the boost dose was not administered or if study partic ipants permanently discontinued from IMP administration, partic ipants were to complete all assessments planned for that visit and for the
EoT Visit as listed in the SoA; The additional Visit 5a added by protocol amendment 06 will only applied for participants who ga ve consent.
Abbreviations: AE = adverse event; CMI = cell-mediated immune t esting; D or d = day; ECG = electr ocardiogram; EDTA = ethylenedia mine tetraacetic acid; EoT = end of treatment (Visit); FU = fol low-up
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Demography and other baseline characteristics
The demographic and other baseline characteristics collected in  this study were: age (in 
years/months), gender (male/female), ethnic group, and medical history information.
The collection of demographic and other baseline characteristic s data is described in 
Protocol Section 10.12 .
Genetics, biomarkers, and immunogenicity assessments
Details of the genetic assessments are provided in Protocol Section 8.7.
Details of the biomarker assessments are provided in Protocol Section 8.8 .
Details of the immunogenicity (antibody response) assessments a re provided in Protocol 
Section 8.9 .
Safety assessments
The safety data collected in this  study were: physical examinati ons, vital signs, ECG, 
clinical laboratory tests, drugs of abuse screens, tests for al cohol use, viral screening, 
participant diaries, assessment of local reactions, SAR-CoV-2 t esting, participant hotline, 
participant wellbeing questioning, assessment of systemic reactions, and AE reporting.The collection of safety data in the study is described in Protocol Section 8.3 (for AEs and 
SAEs) and Protocol Section 8.2 (all other safety assessments).
Appropriateness of measurements
The safety assessments, which included the assessments of AEs a nd local/systemic 
reactivity in support of the primary study objective, were performed using standard 
procedures.
Data quality assurance
Site selection, clinical monitoring, and site performance
The accuracy and reliability of  the study data were assured by the selection of qualified 
investigators and appropriate study sites, review of protocol procedures with the investigator and associated personnel prior to the study, and b y periodic monitoring visits 
by the sponsor or sponsor’s representative.
An investigators’ meeting took place before the study started. All investigators not present 
at that meeting were informed either by the CRO or by the spons or.
Written instructions were provided for the collection, preparat ion, and shipment of 
samples. Electronic CRFs were used in the study. Instructions f or completing the CRFs 
were provided and reviewed with  study personnel prior to the st art of the study. Training 
had to be successfully completed before access to the system wa s allowed.
All CRF entries, corrections, and alterations were made by the investigator or other 
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accurate and correct. The CRFs were reviewed for accuracy and c ompleteness by the 
sponsor and sponsor’s representative and any discrepancies were resolved wi th the 
investigator or designees as appropriate. For details, see Protocol Sections 10.11.1 and 
10.11.3 .
Assessment of CRO performance
The CRO for the study conduct was qualified according to the sp onsor’s standard 
operating procedures (SOPs) in cooperation with the sponsor’s q uality assurance 
department. Before the study start ed, the CRO’s SOPs were reviewed. The conduct of the 
study was performed according to the CRO’s SOPs. The sponsor performed CRO 
activities oversight.
Data quality control procedures
Study data not recorded in the CRF were transferred electronica lly using a secure method 
to the data management center at predefined intervals during th e study in a data structure 
agreed with the sponsor.
Data verification was performed on the data in the database usi ng computerized checks 
looking for missing data, inconsistencies, and incorrect values . A manual review of the 
data was also performed. If necessary, queries were generated and transmitted to the site. 
The investigator was requested to confirm or make corrections o r enter additional or 
missing data as required. Further  data quality control measures  were defined in the data 
validation plan, which are filed in the TMF.
In addition, a reconciliation of reportable adverse events betw een the global drug safety 
and clinical databases as well as a reconciliation of other non -CRF data were performed.
Data documentation and archiving
Thehandling of CRFs, genetic data, source data, the investigator’s site file, and the TMF 
are described in Protocol Section 10.11 .
Audit procedures
The Mannheim study site was inspected by relevant authorities (t he “Regierungspräsidium 
Karlsruhe” and P aul-Ehrlich-Institut) on 07 OCT 2020, 08 OCT 2020, and 22 OCT 2020.
Statistical methods and determination of sample size
Statistical and analytical plans
9.10.1.1 GeneralThe statistical planning and analysis of the study was performed at the statistical CRO 
under supervision of the sponsor’s delegate.
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xTEAE-SI
Moreover, the number and percentage of participants with any AE  were summarized by 
worst grade by PT nested within SOC.
Local reactions and systemic reactions were graded using criter ia based on the guidance 
given in US FDA Guidance for Industry “Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled i n Preventive Vaccine Clinical T rials” .
For each dose, the number and percentage of participants report ing at least one local 
reaction or systemic reaction (i.e ., solicited data collected u sing participant diaries) were 
summarized for each of the following types using the Safety Set :
xAny local reactions or systemic reactions
xGrade ≥3 local reactions or systemic reactions
Moreover, the number and percentage of participants reporting a t least one local reaction 
were summarized by worst grade using the Safety Set.
9.10.1.6 Secondary endpoint analysis
The secondary endpoints are defined in Section 8.
Details of the secondary analyses are provided in SAP Section 6.5 .
All secondary analysis endpoints will be summarized by group (i .e., by vaccine type and 
cohort) and all cohorts combined for each type (cohort-total). The binary secondary 
endpoints were summarized by dose group presenting absolute and  relative frequencies 
(n and %) of participants in each category for each assessment.  The continuous 
secondary endpoints are summarized by dose group using summary statistics.
9.10.1.7 Analysis of other safety analysesDetails of the analysis of other  safety variables are provided in SAP Section 6 .
Clinical laboratory
The clinical laboratory parameters summarized and assessed are listed in Protocol 
Section 10.2 .
Clinical laboratory parameters at each time point and change fro m baseline to each post-
baseline time point were summar ized using descriptive summary s tatistics for each 
parameter by dose group.
Shift tables from baseline to worst intensity grade are provide d for each laboratory 
parameter by dose group.
Additionally, the occurrence of clinically significant abnormal  laboratory results within a 
study participant were analyzed using descriptive summary stati stics for each parameter 
and visit by dose group.
Abnormal laboratory results were graded using criteria based on the guidance given in US 
FDA Guidance for Industry “Toxicity Grading Scale for Healthy Adult and Adolescent 
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Laboratory parameter results were listed along with the normal ranges. Values that are 
below or above the normal ranges were flagged.
Vital signs
The vital sign parameters to be summarized and assessed are giv en in Protocol 
Section 8.2.2 .
Vital sign parameters at each time point and change from baseli ne to each post-baseline 
time point were summarized using descriptive summary statistics  for each parameter by 
dose group.
ECG
ECG parameters to be summarized and assessed are given in Protocol Section 8.2.3.
ECGs were judged by the investigator as clinically significant ( yes/no).
Further safety data
Physical examination, drugs of abuse, alcohol use, viral screen ing and the SARS-CoV-2
testing was listed.
Compliance
IMP compliance will be summarized by group (i.e., by vaccine ty pe and cohort) and cohort-
total. Drug exposure will be listed.
9.10.1.8 Interim analysis
In Part A, no formal interim statistical analysis was performed. However, preliminary 
analyses based on all data collected until a predefined data cut -off date (snapshot 
analyses) could be performed for each cohort once subjects withi n a cohort have been 
followed up for at least 7 days following the dose. An analysis update is planned once all 
subjects have completed Visit 10.
Sample size rationale
No formal sample size calculations were performed.For Part A, the inclusion of 12 participants per dose group was considered to be adequate 
for a safety assessment of each IMP per dose level. The probabi lity to observe a particular 
TEAE with incidence of 15% at least once in 12 participants per  dose group is 85.8%.
Data available for this interim report
This third interim CSR summarizes reactogenicity and safety dat a available for BNT162b1 
and BNT162b2 collected up until Visit 8 (the first follow-up vis it at ~63 d after the second 
dose) for dose-escalation and dose-expansion dose groups in Par t A of this study, 
therefore this CSR only describes the study conduct relevant fo r these dose groups. This 
CSR differs from the second interim CSR in that additional CMI data were added for a 
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Changes in the conduct of the study or planned analyses
Changes in the conduct of the study
9.12.1.1 Amendments to the protocol
Changes made to the protocol using the protocol amendments are described in detail in 
the document Protocol Amendment History provided in Appendix 16.1.1.3 .
9.12.1.2 Discrepancies between protocol and the CRFThere were no discrepancies between the protocol and the CRF.
9.12.1.3 Other changes in the conduct of the study
In a small number of participant s receiving 10, 20, and 30 μg BNT162b2, CMI was 
assessed using research samples c ollected at Visit 8 (63 d post-Dose 2) and Visit 9 (162 d
post-Dose 2).Dosing of participants with the second 60 μg BNT162b1 dose was not performed. After 
12 participants had received Dose 1, the SRC decided not to administer Dose 2 to these participants.
There were no other changes in the conduct of the study conside red by the sponsor to 
either impact the study objective s or to have compromised parti cipant safety.
Changes in the planned analyses
There was one change in the analyses as described in the SAP.
The SAP states that functional antibody response data from VisMederi Srl will be used for 
the analysis of functional antibody responses; this is correct for the main analysis that will 
be reported in the final CSR. However, for this interim CSR, fu nctional antibody response 
data from Pfizer Inc. (Pearl River, NY, US) / University of Texas Medical Branch, Galveston, TX, US) are reported (for details see Report R-20-0253 ). This was done to 
enable comparison of data from this study with data from the cl inical study BNT162-
02/C4591001 (ClinicalTrials.gov NCT04368728) which reports func tional antibody 
response data from Pfizer Inc. (Pearl River, NY, US) / Universi ty of Texas Medical Branch, 
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10 STUDY PARTICIPANTS
This report covers study conduct and results for BNT162b1 and BN T162b2 in healthy 
younger participants (aged 18 to 55 yrs) and older participants (aged 56 to 85 yrs).
Disposition of participants
BNT162b1
The disposition of the 84 younger participants is given in Figure 2 . This disposition relates 
to the reactogenicity, safety, disposition, and immunogenicity data (data cut-off 
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Figure 2: Disposition of younger participants –BNT162b1
AE = adverse event; EoT Visit (Visit 7) completed = end of treatment visit completed (as recorded in the database at the 23 OCT 20 20 data cut-off date); N = number of participants; SAF = safety set ; 
SAFB = safety boost set; Dose 2 + 28 d assessed (CB28) = Dose 2 + 28 d c ompleter set.
Source: Based on data from Table 14.1-2-1 ,Table 14.1-3.1-1 , and Listing 16.2.1-1-1.
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The disposition of the 36 older participants is given in Figure 3 .
Figure 3: Disposition of older participants –BNT162b1
EoT Visit (Visit 7) completed = end of treatment visit completed (as recorded in the database at the 23 OCT 2020 data cut-off date) ; N = number of participants; SAF = safety set; SAFB = safety boost  
set; Dose 2 + 28 d assessed (CB28) = Dose 2 + 28 d completer set.
Source: Based on data from Table 14.1-2-1 ,Table 14.1-3.1-1 , and Listing 16.2.1-1-1.
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A total of 84 younger participants and 36 older participants (in  total 120 participants) were 
enrolled in BNT162b1 dose groups in Part A of this study. At the data cut-off 
(23 OCT 2020), the Dose 2 + 28 d completer set (CB28) comprised 69 o f 84 younger and 
12 of 36 older participants ( Table 14.1-2-1 ), and 80 of 84 younger and 11 of 36 older 
participants had completed Visit 7 (the EoT Visit) ( Listing 16.2.1-1-1 ).
Four younger participants discontinued prematurely from the stu dy (Table 14.1-3.1-1 ).
One younger participant discontinued prematurely from the study due to AEs after Dose 1
(Participant 10010 in the 10 μg dose group); these AEs were asses sed as not related to 
the IMP by the investigator ; for details see Section 12.6.1 .
Three younger participants discontinued prematurely for reasons n ot due to AEs (in the 
20 μg dose group: Participant 10178 [other/private reason; after Dose 2], Participant 
10182 [withdrawal by participant; after Dose 1]; Participant 1005 0 [other/private reason; 
after Dose 1]) in the 50 μg dose group.
Note that Participant 10178 in the 20 μg dose group discontinued  prematurely later than 
28 d after Dose 2 but did not complete the EoT visit.Twelve younger participants (10066, 10075, 10076, 10078, 10083, 10084, 10085, 10089, 
10093, 10096, 10103, and 10104) in the BNT162b1 60 μg dose group did not receive 
Dose 2 due to a SRC decision but completed their EoT visits. Although the observations 
after Dose 1 at 60 μg did not raise safety concerns, the high leve l of inter-individual 
differences and the limitations of the data available at that t ime were considered as not 
enough to allow administration of Dose 2.
For further details, see Listing 16.2.1-1-1 and Listing 16.2.1-3-1 .
BNT162b2
The disposition of the 60 younger participants is given in Figure 4 . This disposition relates 
to the reactogenicity, safety, disposition, and immunogenicity data (data cut-off 
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Figure 4: Disposition of younger participants –BNT162b2
AE = adverse event; EoT Visit (Visit 7) completed = end of treatment visit completed (as recorded in the database at the 23 OCT 20 20 data cut-off date); N = number of participants; SAF = safety set;  
SAFB = safety boost set; Dose 2 + 28 d assessed (CB28) = Dose 2 + 28 d completer set.
Source: Based on data from Table 14.1-2-3 ,Table 14.1-3.1-3 , and Listing 16.2.1-1-3 .
.
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The disposition of the 36 older participants is given in Figure 5 .
Figure 5: Disposition of older participants –BNT162b2
EoT Visit (Visit 7) completed = end of treatment visit completed (as recorded in the database at the 23 OCT 2020 data cut-off date) ; N = number of participants; SAF = safety set; SAFB = safety boost  
set; Dose 2 + 28 d assessed (CB28) = Dose 2 + 28 d completer set.
Source: Based on data from Table 14.1-2-3 ,Table 14.1-3.1-3 , and Listing 16.2.1-1-3 .
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Participants dosed with BNT162b1 showed a strong dose-dependent  antibody response. 
On Day 22, at 21 d after Dose 1, virus neutralizing antibody GMTs (neutralizing GMTs) 
had increased in a dose-dependent manner for the 1, 10, 30, and  50 μg dose groups. At 
7 d after Dose 2 (Day 29), neutralizing GMTs showed a strong, dose level dependent 
booster response. In the 60 μg dose group, which was only dosed o nce, neutralizing 
GMTs remained at a lower level, indicating that a booster dose is necessary to increase 
functional antibody titers.
On Day 43 (21 d after the Dose 2 of BNT162b1), neutralizing GMTs de creased (with 
exception of the 1 μg dose level). Day 43 virus neutralizing GMTs were 0.7-fold (1 μg) to 
3.6-fold (50 μg) those of a COVID-19 HCS panel.
The COVID-19 HCS panel is comprised of 38 human COVID-19 HCS se ra drawn from 
individuals aged 18 to 85 yrs, at least 14 d after confirmed diag nosis, and at a time when 
the individuals were asymptoma tic. The serum donors predominant ly had symptomatic 
infections (35/38), and one had been hospitalized. The sera wer e obtained from Sanguine 
Biosciences (Sherman Oaks, CA), the MT Group (Van Nuys, CA), and Pfizer Occupational 
Health and Wellness (Pearl River, NY).
Participants dosed with BNT162b2 showed a strong IMP-induced an tibody response. Virus 
neutralizing GMTs were detected at 21 d after Dose 1 (Day 22) and had increased 
substantially in younger participants (aged 18 to 55 yrs) immunized with ≥3 μg BNT162b2, 
and older participants (aged 56 to 85 yrs) immunized with 20 μg BN T162b2 by 7 d after 
Dose 2 (Day 29). Day 29 virus neutralizing GMTs were comparable between the younger and older adult 20 μg dose groups. The lowest tested dose of 1 μg B NT162b2 elicited only 
a minimal neutralizing response in participants aged 18 to 55 yr s.
On Day 43 (21 d after Dose 2 of BNT162b2), virus neutralizing GMTs  in the younger adult 
dose groups decreased for the 3, 20, and 30 μg dose levels. There after, neutralizing 
GMTs in between Days 29 and 43, neutralizing GMTs remained stabl e up to Day 85 (63 d
after Dose 2) for younger adult dose groups 10, 20, and 30 μg and were 1.3-fold to 1.9-fold 
those of a COVID-19 HCS panel.
Seroconversion is defined as a minimum of a 4-fold increase of antibody GMT as 
compared to baseline. The frequency of participants with seroconversion is displayed in
Figure 10 (BNT162b1) and Figure 11 (BNT162b2).
All participants dosed with Dose 1 at ≥30μg BNT162b1 or BNT162b2 seroconverted either 
by 7 d or 21 d after Dose 2 (Day 29 or Day 43). All participants dosed with 30 μg
BNT162b2 remained seropositive t hroughout the follow-up until Day 85.
For further details on the functional antibody responses agains t the SARS-CoV-2 S protein 
S1 subunit, see the interim report R-20-0253 .
The methodology used for the assessments and complete results a re presented in the 
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Cell-mediated immune responses
For an overview of the CMI analysis sets, see Section 10.4.
SARS-CoV-2-specific CD4+and CD8+T-cell responses
In order to assess immunogenicity of the vaccine candidates, pe ripheral blood T cells of 
the study participants were analyzed for CD4+and CD8+T cells specific for the 
SARS-CoV-2 spike protein. This analysis was performed using ex vivo interferon J(IFNJ)
ELISpot on blood samples collected on pre-Dose 1 and on Day 29 (i. e., 7 d post-Dose 2).
In a subset of study participants who received 10, 20, and 30 μg B NT162b2, blood 
samples were also collected on Day 85 (i.e., 63 d post-Dose 2) and Day 184 (i.e., 162 d
post-Dose 2) and analyzed. The ELISpot assay was performed under GCP conditions 
within the analytical study GA-RB-022-01A by the Biolytics-GCP test facility, providing an 
expert call on the presence or absence of T-cell responses, as well as spot count data for 
each vaccine target in each sample. The spot count data were further processed and 
normalized based on T-cell fitness/content of each sample, in o rder to enable accurate 
interpretation of the immunogenicity of BNT162b1 and BNT162b2.
As of 02 MAR 2021, evaluable CD4+and CD8+T-cell response data were available from 
97 study participants that received BNT162b1, 70 younger participa nts at dose levels of 1, 
3, 10, 20, 30, 50, or 60 μg (note: Dose 2 was not given in the 60 μg dose group), and 
27 older participants at dose levels of 10, 20, or 30 μg. This included:
xYounger participants aged 18 to 55 yrs per dose group: 1 μg (n=11 ), 3 μg (n=11), 
10 μg (n=11), 20 μg (n=8), 30 μg (n=10), 50 μg (n=10), and 60 μg (n= 9).
xOlder participants 56 to 85 yrs pe r dose group: 10 μg (n=8), 20 μg  (n=8), and 30 μg 
(n=11).
As of 02 MAR 2021, evaluable CD4+and CD8+T-cell response data were available from 
76 participants that received BNT162b2 in Dose Groups 1 to 10 at dose levels of 1, 3, 10, 
20, or 30 μg (47 younger participants), or 10, 20, or 30 μg (29 old er participants). This 
included:
xYounger participants aged 18 to 55 yrs per dose group: 1 μg (n=9), 3 μg (n=10), 
10 μg (n=9), 20 μg (n=9), and 30 μg (n=10).
xOlder participants 56 to 85 yrs per dose group: 10 μg (n=10), 20 μg (n=9), and 30 μg (n=10).
To assess the persisten ce of cell-mediated immune responses, as of 02 MAR 2021, 
evaluable CD4
+/CD8+T-cell response data at Days 85 and 184 (i.e., 9 and 23 wks post-
Dose 2, respectively) are also ava ilable for 24 study participan ts that received BNT162b2 
(20 younger participants at dose levels of 10, 20, or 30 μg, and 4 older participants at dose 
levels of 10, 20, or 30 μg).
The following results are based o n assessment of T cell data col lected on Day 1 (before 
Dose 1), Day 29, Day 85, and Day 184 (i.e., 1, 9, and 23 wks post-Dose 2, respectively).BNT162b1 induced strong RBD-specific CD4
+T-cell responses in the majority of study 
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participants (27 of 27 [100%]); CD8+responses were induced in 47 of 61 (77.0%) younger 
participants and in 21 of 27 (77.7%) older participants. In contrast, T-cell responses were 
detected less often and were lower in magnitude in 9 younger par ticipants who received 
only Dose 1 in the 60 μg dose group, indicating the importance of a booster dose.
BNT162b2 induced strong SARS- CoV-2 S protein-specific CD4+T-cell responses in all of 
the dosed younger or older participants (76 of 76 [100%]); CD8+T-cell responses were 
induced in 45 of 47 (95.7%) younger participants and 24 of 29 (82. 8%) older participants.
Despite the slightly lower CD8+immunogenicity rate in older participants, the magnitude of 
the BNT162b2-induced responses was comparable to those induced i n younger 
participants who received 30 μg of BNT162b2. These T-cell responses  were directed 
against different parts of the antigen including non-RBD sequen ces, indicating the 
induction of multi-epitopic responses by BNT162b2 in both age g roups.
Dosing twice with BNT162b1 or BNT 162b2 led to a substantial increase in incidence and 
magnitude of T-cell responses in both age groups, and across all dose levels for 
BNT162b1. While the magnitude of CD4+T-cell responses induced by BNT162b2 was 
also similar across different dose levels, the magnitude of CD8+T-cell responses was 
highest at the 30 μg dose level. The participants with the stronge st CD4+T-cell responses 
had more than 10-fold of the memory responses observed in the same participants against immunodominant peptides from cytomegalovirus, Epstein-Barr virus, influenza virus, and tetanus toxoid. The same participants also had strong CD8
+T-cell responses that were 
comparable to memory responses against the above mentioned vira l antigens.
BNT162b2-induced CD4+and CD8+T-cell responses showed a decrease on Day 85, but 
remained detectable on Day 184 in almost all participants vaccin ated with >10 μg at levels 
higher than or in range of recall antigen memory responses. The durability of BNT162b2-
induced T-cell responses is shown in Figure 16 .
RBD- and S protein-specific CD4+T-cell responses observed after vaccination were 
induced by BNT162b1 in 97.5% of participants and by BNT162b2 in 100% of participants.
RBD- and S protein-specific CD8+T-cell responses observed after vaccination were 
induced by BNT162b1 in 95.5% of participants and by BNT162b2 in 96.6% of participants.
The methodology used to assess the BNT162b1 and BNT162b2 elicited T-cell responses 
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Figure 16: Durability of BNT162b2-induced T-cell responses
PBMCs obtained on Day 1 (before Dose 1), Day 29, Day 85, and Day 184  (7 d, 9 wks, and 23 wks post-Dose 2, respectively), were 
analyzed in ex vivo IFNJELISpot (for details see GA-RB-022-01A ). Common pathogen T-cell epitope pools CEF (CMV, EBV, and 
influenza virus HLA class I epitopes) and CEFT (CMV, EBV, influen za virus, and tetanus toxoid HLA class II epitopes) served to as sess 
general T-cell reactivity, cell c ulture medium served as negati ve control. Each dot represents the sum of normalized mean spot  count 
from duplicate wells stimulated with two peptide pools correspo nding to the full-length wild-type S protein for one study parti cipant, after 
subtraction of the medium-only control. Ratios above post-vacci nation data points are the number of participants with detectab le CD4+
or CD8+T-cell responses within the total number of tested participants  per dose group and time point.
IFN = interferon; S protein = SARS-CoV-2 sp ke protein.
Source: Interim report R-20-0244 .
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Functional and pro-inflammatory CD4+/CD8+T-cell responses
De novo induction of SARS-CoV-2 S protein or RBD protein directed T cell s was 
confirmed using ICS. IFN J-producing CD4+and CD8+T cells against SARS-CoV-2
S protein or RBD were induced robustly by both BNT162b1 and BNT1 62b2. No clear dose 
dependency was observed for both IMPs. The cytokine responses elicited after dosing 
with either BNT162b1 or BNT162b2 in older participants was most ly identical in response 
pattern and intensity with that in younger participants.
BNT162b1 and BNT162 induced poly-functional and pro-inflammatory  CD4+/CD8+T-cell 
responses in almost all participants. The detection of IFN J, IL-2 but not IL-4 indicates a 
favorable Th1 profile and the absence of a potentially deleteri ous Th2 immune response.
11.3.2.1 BNT162b1As of 17 NOV 2020, evaluable functional and pro-inflammatory CD 4
+/CD8+T-cell 
response data at baseline (before Dose 1) and at Day 29 (28 d post -Dose 1) are available 
for 95 study participants that received BNT162b1 (68 younger participants at dose levels 
of 1, 3, 10, 20, 30, 50, or 60 μg, and 27 older participants at d ose levels of 10, 20, or 
30 μg). This included:
xYounger participants aged 18 to 55 yrs per dose group: 1 μg (n=10 ), 3 μg (n=10), 
10 μg (n=10), 20 μg (n=6), 30 μg (n=12), 50 μg (n=9), 60 μg (n=11).
xOlder participants aged 56 to 85 y rs per dose group: 10 μg (n=8), 20 μg (n=8), 30 μg 
(n=11).
The functionality and polarization of vaccine-induced SARS-CoV-2 RBD-specific T cells 
were assessed by intracellular accumulation of the cytokines IF NJ, IL-2, and IL-4 in 
response to stimulation with overlapping peptides representing the full-length sequence of 
the vaccine-encoded RBD (amino acids [aa] 1-16 fused to aa 327-528 of the S protein)
and the wild-type SARS-CoV-2 S protein by ICS. For bench-marking , PBMCs from 15 
COVID-19 convalescent virologically confirmed patients were use d.
Two doses of BNT162b1 (dose range 1 to 50 μg) induced cluster of  differentiation 4 (CD4) 
and CD8 vaccine-specific T-cell responses. RBD-specific CD4+T-cell responses have a 
type 1 helper T (Th1) cell cyto kine profile secreting IFN J, or IL-2, or both. For 81 of the 84 
analyzed participants who received both BNT162b1 doses, no produ ction of Th2 cytokine 
IL-4 in response to RBD peptide pool stimulation was detected. Similarly, RBD-specific 
CD8+T cells secreted IFN Jin 54 of the analyzed 84 participants who received both 
BNT162b1 doses, however, lower levels of IL-2-secreting CD8+T cells compared to CD4+
T cells were detected. In the 30 μg dose groups, the fractions of RBD-specific IFN J+CD8+
T cells reached up to 0.49% (younger participants) and 1.58% (olde r participants) of total 
peripheral blood CD8+T cells. In the 50 μg dose group with younger participants, fract ions 
of up to 3.87% were detected. The mean fraction of both CD4+and CD8+cytokine-
producing T cells in the BNT162b1-dosed participants (1 to 50 μg) was substantially higher 
(e.g., for participants dosed at 30 μg, 11-fold higher) than that observed in 15 patients who recovered from COVID-19. In the 60 μg dose group, treated with D ose 1 only, mean 
fractions of cytokine-producing T cells were lower compared to t he other dose groups, 
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elicited after dosing with BNT162b1 in older participants was s imilar in response pattern 
and intensity with that of the younger participants.
BNT162b1 induced poly-functional and pro-inflammatory CD4+/CD8+T-cell responses in 
almost all participants, with a Th1 polarization of the helper response. The detection of 
IFNJ, IL-2 but not IL-4 indicates a favorable Th1 profile and the absence of a potentially 
deleterious Th2 immune response.The methodology used to assess the BNT162b1 elicited antigen-sp ecific CD8
+and CD4+
T-cell responses in samples from study participants dosed with BNT162b1 and complete
results are presented in the interim report R-20-0235 .
11.3.2.2 BNT162b2
As of 02 MAR 2021, evaluable functional and pro-inflammatory CD4+/CD8+T-cell 
response data at baseline (before Dose 1) and at Day 29 (28 d post -Dose 1) are available 
for 79 study participants that received BNT162b2 (50 younger part icipants at dose levels 
of 1, 3, 10, 20, or 30 μg, and 29 older participants at dose leve ls of 10, 20, or 30 μg). This 
included:
xYounger participants aged 18 to 55 yrs per dose group: 1 μg (n=8),  3 μg (n=9), 10 μg 
(n=11), 20 μg (n=11), and 30 μg (n=11).
xOlder participants 56 to 85 yrs per dose group: 10 μg (n=11), 20 μg (n=9), and 30 μg 
(n=9).
The functionality and polarization of vaccine-induced SARS-CoV-2 S-specific T cells were 
assessed by intracellular accumulation of cytokines IFN J, IL-2, and IL-4 in response to 
stimulation with overlapping peptides representing the full-len gth sequence of the vaccine-
encoded RBD and the wild-type SARS-CoV-2 S protein. For bench-ma rking, PBMCs from 
18 virologically confirmed, convalescent COVID-19 patients were used.
To assess the persisten ce of cell-mediated immune responses, of  02 MAR 2021, 
evaluable functional and pro-inflammatory CD4+/CD8+T-cell response data at Days 43, 
85, and 184 (i.e., 3, 9, and 23 wks post-Dose 2, respectively) are also available for 
41 study participants that received BNT162b2 (23 younger participants at dose levels of 
10, 20, or 30 μg, and 18 older participants at dose levels of 10, 20, or 30 μg). This included:
xYounger participants aged 18 to 55 yrs per dose group: 10 μg (n=2 ), 20 μg (n=11), 
and 30 μg (n=10).
xOlder participants 56 to 85 yrs per dose group: 10 μg: (n=4), 20 μ g (n=7), and 30 μg 
(n=7).
Two doses of BNT162b2 (dose range 1 to 30 μg), induced vaccine-s pecific T-cell 
responses in both age groups analyzed at Day 29 ( Figure 17 andFigure 18). Testing for 
SARS-CoV
-2 S protein-specific T-cell responses was performed with two dif ferent peptide 
pools –S pool 1 comprising overlapping peptides from the N-terminal regi on of the 
S protein (which is not equivalent to structural domains) and S pool 2 comprising C-terminal regions of the S protein. S-specific CD4
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towards Day 85 (63 d post-Dose 2). This observation held true for a ll dose groups 
analyzed with varying response magn itudes between individuals. For the younger 
participants, the cell-mediated immune responses remained detec table until Day 184
(162 d post-Dose 2). Day 184 PBMC material from the older participa nts was not yet 
available at the time of this interim report. The impact of a S ARS-CoV-2 infection on the 
persistence of vaccine-induced immune responses cannot be evalu ated since the 
participants were not monitored for an infection on a regular b asis during the course of this 
study.
For persistence of S-specific CD4+and CD8+T cells producing the indicated cytokines 
(IFNJand IL-2) as a fraction of total circulating CD4+and CD8+T cells see Figure 19 . This 
figure shows the data for the 30 μg BNT162b2 dose group in younge r and older 
participants and is considered representative of what is seen fo r other dose groups. For 
details of what is seen for other dose groups, see the interim report R-20-0241 .
BNT162b2-induced T-cell responses, especially for CD8+T cells, were not limited to the 
RBD, and pronounced and strong T cell recognition of non-RBD reg ions of the S protein 
were observed indicating a polyvalent immune recognition of multiple independent MHC I
and II epitopes across the entire S protein.
BNT162b2 induced poly-functional and pro-inflammatory CD4+/CD8+T-cell responses in 
almost all participants persistin g in the majority of participa nts for up to 6 months after 
Dose 1. The Th1 polarization of the helper T-cell response was c haracterized by a robust 
IFNJ/IL-2 and only minor IL-4 production upon antigen-specific (wild-type SARS-CoV-2
S protein peptide pools) re-stimulation which was still observed , although with a reduced 
magnitude, at later time points.
The methodology used to assess the BNT162b2 elicited antigen-spe cific CD8+and CD4+
T-cell responses in samples from study participants dosed with BNT162b2 and complete 
results are presented in the interim report R-20-0241 .090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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Figure 19: Persistence of S-specific CD4+and CD8+T cells producing the indicated cytokines (IFN J
and IL-2) as a fraction of total circulating CD4+and CD8+T cells (30 μg BNT162b2 dose 
group in younger and older participants)
Cytokine data are plotted for participants from (a) the 30 μg dos e group in younger participants (aged 18 to 55 yrs, n=10) and (b ) 30 μg 
dose group in older participants (aged 56 to 85 yrs, n=7) from D ay 1 (before Dose 1), Day 29 (7 d post-Dose 2), Day 43 (3 wks post-
Dose 2), Day 85 (9 wks post-Dose 2) and Day 184 (23 wks post-Dose 2, ( a) only) after Dose 1. Green dotted lines indicate the time 
point of Dose 2 (Day 22).
IFN = interferon; IL = interleukin.Source: Interim report R-20-0241 .
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Genetics
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12.2.1.2 Older participants and all (younger and older) particip ants
A total of 30 participants (83%) reported solicited local react ions, of which none of the 
participants reported Grade ≥3 solicited local reactions. A total of 33 participants (92%) 
reported solicited systemic reactions, of which 10 participants  (28%) reported Grade ≥3 
solicited systemic reactions.
A total of 13 participants (36%) reported in total 24 TEAEs, of w hich 9 events were related 
TEAEs. Four participants (11%) reported Grade ≥3 TEAEs of which one event was 
assessed as related by the investigator.There were no deaths and one participant had a TESAE (syncope).There were no TEAEs of special interest (TEAE-SI).
Table 17 provides an overview of older participants with solicited react ogenicity events or
unsolicited TEAEs.
For both the younger and older participants, there was a clear d ose relationship for 
solicited local reactions and for systemic reactions.
BNT162b2
12.2.2.1 Younger participants
A total of 52 participants (87%) reported solicited local reactions. A total of 53 participants 
(88%) reported solicited systemic reactions, of which 6 particip ants (10%) reported 
Grade ≥3 solicited systemic reactions.
A total of 26 participants (43%) reported in total 51 TEAEs, of w hich 6 events were related 
TEAEs. One participant (2%) reported a Grade ≥3 TEAE which was assessed as n ot 
related by the investigator.
There were no TESAEs or deaths. One AE (moderate nasopharyngitis) led to 
discontinuation.
There were no TEAEs of special interest (TEAE-SI). TEAE-SI are d efined as: Enhanced 
respiratory disease or flu-like symptomatology not resolved aft er 7 d or with symptom 
kinetics that are inconsistent with a relationship to RNA immun ization.
Table 18 provides an overview of younger participants with solicited rea ctogenicity events 
or unsolicited TEAEs.
12.2.2.2 Older participants and all (younger and older) particip ants
A total of 31 participants (86%) reported solicited local reacti ons, of which 2 participants 
(6%) reported Grade ≥3 solicited local reactions . A total of 26 participants (72%) reported 
solicited systemic reactions, of which 4 participants (11%) repo rted Grade ≥3 solicited 
systemic reactions.
A total of 12 participants (33%) reported in total 20 TEAEs, of w hich 2 events were related 
TEAEs. Three participants (8%) reported Grade ≥3 TEAE s of which one event was 
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Solicited local reactions
Solicited local reactions within 7 d after each BNT162b1 dose
A summary of solicited local reactions is presented in Table 19 . All solicited local reaction 
data by participant is given in Listing 16.2.3-1.1-1 .
12.3.1.1 Younger participants
Within 7 d after Dose 1;
x81% of the younger participants reported at least one local rea ction of any grade on 
at least one occasion.
xIn total 10 younger participants reported Grade ≥3 local reactions.
xIn the younger participants group, a possible dose dependency for Grade ≥3 local 
reactions between the 10 μg group (1 participant) and the 20 μg and 30 μg groups (2 
and 4 participants) was seen.
Within 7 d after Dose 2;
x80% of the younger participants reported at least one local rea ction of any grade on 
at least one occasion.
xIn total 7 younger participants reported Grade ≥3 local reactions.
xIn the younger participants group, a possible dose dependency for Grade ≥3 local 
reactions between the 10 μg group (0 participants) and the 30 μg and  50 μg groups 
(2 and 3 participants) was seen. The Dose 2 in the 60 μg group was omitted due to 
the SRC decision.
Across the two intervals combine d, 72 participants (86%) in the  younger participants group 
reported any local reaction at any dose, of which 15 (18%) part icipants reported a 
Grade ≥3 local reaction with a possible dose dependency between 10 μg (1 participant) 
and 20 μg and 30 μg (2 and 5 participants) doses.
12.3.1.2 Older participants
Within 7 d after Dose 1;
x81% of the older participants reported at least one local react ion of any grade on at 
least one occasion.
xNo older participants reported Grade ≥3 local reactions.
xA possible dose dependency for local reactions between the 10 μg group 
(7 participants) and the 20 μg and 30 μg groups (11 participants) wa s seen.
Within 7 d after Dose 2;
x74% of the older participants reported at least one local react ion of any grade on at 
least one occasion.
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54%) solicited local reactions. While few participants experien ced severe (n=15, 18%) 
solicited local reactions.
xThe most frequent severe solicited local reactions were reported in 30 μg
(5 participants [42%]), 50 μg (4 participants [33%]), 20 μg (2 partici pants [17%]), 
60 μg (1 participant [8%]), and 10 μg (1 participant [8%]) dose groups.
The most frequently reported solicited local reactions of any s everity were tenderness 
(n=70, 83%) and pain (n=67, 80%). The remaining symptom terms wer e less frequent.
xOnly mild and moderate reactions were reported for erythema and  induration.
xFor pain and tenderness each symptom was assessed as severe in ≤14% of 
participants.
xNo clear pattern of dose dependency was seen across the symptom  terms for mild 
reactions in 10 μg and above dose groups. However, a possible dos e dependency for 
moderate local reactions between the 10 μg group (5 participants) and the 20 μg and 
30 μg groups (6 and 11 participants) was seen.
12.3.2.2 Older participants and all (younger and older) particip ants
In the older participants group, in the combined time interval,  after both doses, the majority 
of the participants experienced mild (n=30, 83%) followed by mod erate (n=15, 42%)
solicited local reactions, while no older participants experien ced severe solicited local 
reactions.
The most frequently reported solicited local reactions of any s everity were tenderness 
(n=28, 78%) and pain (n=27, 75%). The remaining symptom terms we re less frequent.
xOnly mild reactions were reported for erythema and induration.
xFor pain and tenderness each symptom was assessed as moderate i n <40% of 
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All = all is the sum of younger and older participants; N = num ber of participants in the analysis set; n = number of particip ants with the 
respective local reaction; nn = number of participants with any information on local reactions available; SAF = Safety Set.
Source: modified from Table 14.3.1-1.3-1 .
Time to onset and duration of local reactions –BNT162b1
12.3.3.1 Younger participants
In the younger participants group, the mean time (SD) from Dose 1 to first local reaction 
was 1.1 d (0.4), while the mean time (SD) from first to last loc al reaction was 3.0 d (1.8). 
The mean time (SD) from Dose 1 to first Grade ≥3 local reaction was 1.5 d( 0 . 5 ) .  T h e  
mean time (SD) from first to last Grade ≥3 local reaction was 1.2 d (0.4) ( Table 14.3.1-
1.5.1-1 ).
The mean time (SD) from Dose 2 to first local reaction was 1.1 d (0.6), while the mean 
time (SD) from first to last local reaction was 3.5 d (1.9). The mean time (SD) from Dose 2to first Grade ≥3 local reaction was 1.1 d (0.4). The mean time (SD) from first to last 
Grade ≥3 local reaction was 1.9 d (1.2) ( Table 14.3.1-1.5.1-1 ).
After Dose 1, for almost all participants, except for 1 (10%) for  the 30 μg dose group there
were no local reactions on Day 7. After Dose 2, except for 1 (10%) f or the 10 μg dose 
group there were no local reactions on Day 7. ( Table 14.3.1-1.6.1-1 ).
The participant’s diary compliance for reporting local reaction s after Dose 1 was 100% up 
to Day 6, while after Dose 2 it was ≥ 81% up to Day 5 before dropping on Days 6 and 7 in 
some dose groups ( Table 14.3.2-1.2-1 ,Listing 16.2.3-1.2-1 ).
12.3.3.2 Older participants and all (younger and older) particip ants
In the older participants group, the mean time (SD) from Dose 1 t o first local reaction was 
1.1 d (0.3), while the mean time (SD) from first to last local reaction was 2.8 d (1.6). The 
mean time (SD) from Dose 1 to first Grade ≥3 local reaction was 1.5 d (0.5). The mean 
time (SD) from first to last Grade ≥3 local reaction was 1.2 d (0.4) ( Table 14.3.1-1.5.1-1 ).
The mean time (SD) from Dose 2 to first local reaction was 1.1 d (0.5), while the mean time (SD) from first to last local reaction was 3.5 d (2.0). The  mean time (SD) from Dose 2
to first Grade ≥3 local reaction was 1.1 d (0.4). The mean time (SD) from first to last 
Grade ≥3 local reaction was 1.9 d (1.2) ( Table 14.3.1-1.5.1-1 ).
After Dose 1, there were no local reactions in any dose group af ter Day 5. After Dose 2, 
except for 1 (11%) for the 20 μg dose group there were no local reactions on Day 7.
(Table 14.3.1-1.6.1-1 ).
The participant’s diary compliance for reporting local reaction s after Dose 1 was ≥99% up 
to Day 6, while after Dose 2 it was ≥ 86% up to Day 5 before dropping on Days 6 and 7 in 
some dose groups ( Table 14.3.2-1.2-1 ,Listing 16.2.3-1.2-1 ).
Descriptive statistics of time of solicited local and any solic ited reactions by term is 
presented in Table 14.3.1-1.5.2-1 . A summary of solicited local reactions reported by 
participants (who completed doses  1 and 2) within 7 d after each  dose is presented in 
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participants (who completed doses  1 and 2) within 7 d after each  dose is presented in 
Table 14.3.1-1.4-1 .
Solicited local reactions within 7 d after each BNT162b2 dose
A summary of solicited local reactions is presented in Table 21 . All solicited local reaction 
data by participant is given in Listing 16.2.3-1.1-3 .
12.3.4.1 Younger participants
Within 7 d after Dose 1;
xA total of 82% of participants reported at least one local reaction of any grade on at 
least one occasion.
xNone of the participants reported Grade ≥3 local reactions.
Within 7 d after Dose 2;
xA total of 74% of participants reported at least one local reac tion of any grade on at 
least one occasion.
xNone of the participants reported Grade ≥3 local reactions.
Across the 2 intervals combined, 52 participants (87%) reported any local reaction at any 
dose, of which none of the participants reported Grade ≥3 local reactions.
12.3.4.2 Older participants and all (younger and older) particip ants
Within 7 d after Dose 1;
xA total of 69% of participants reported at least one local reac tion of any grade on at 
least one occasion.
xNone of the participants reported Grade ≥3 local reactions.
Within 7 d after Dose 2;
xA total of 69% of participants reported at least one local react ion of any grade on at 
least one occasion.
xGrade ≥3 local reactions were reported by 2 participants (6%).
Across the 2 intervals combined, 3 1 participants (86%) reported a ny local reaction at any 
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xThe most frequently reported solicited local reactions of any severity was mild 
tenderness (n=45, 75%) and mild pain (n=45, 75%). The remaining  symptom terms 
were less frequent.
xOnly mild reactions were reported for erythema and induration.
xPain was assessed as moderate in ≤10% of participants.
xNo clear pattern of dose dependency was seen across the symptom  terms for mild or 
moderate reactions.
12.3.5.2 Older participants and all (younger and older) participa nts
In older participants, in the co mbined time interval, after bot h doses, the majority of the 
participants experienced mild (n=28, 78%) solicited local react ions. A few participants 
experienced moderate (n=13, 36%) solicited local reactions.
xThe most frequent, moderate grade solicited local reactions wer e reported in 30 μg
(n=6, 50%) followed by 20 μg (n=4, 33%) and 10 μg (n=3, 25%) dose g roups.
xThe most frequently reported solicited local reactions of any severity was mild tenderness (n=24, 67%) followed by mild pain (n=22, 61%). The r emaining symptom 
terms were less frequent.
xOne participant had a moderate reaction of erythema and only mi ld reactions were 
reported for induration.
xPain was assessed as moderate in ≤14% of participants.
xNo clear pattern of dose dependency was seen across the symptom  terms for mild or 
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Time to onset and duration of local reactions –BNT162b2
12.3.6.1 Younger participants
The mean time (SD) from Dose 1 to first local reaction was 1.1 d (0.3), while the mean 
time (SD) from first local reaction to last local reaction was 2.1 d (1.1). The mean time from 
Dose 1 to first Grade ≥3 local reactions was not estimable. The mean time from first to last 
Grade ≥3 local reactions was not estimable ( Table 14.3.1-1.5.1-3 ).
The mean time (SD) from Dose 2 to first local reaction was 1.2 d (0.4), while the mean 
time (SD) from first to last local reactions was 2.5 d (1.4). Th e mean time (SD) from 
Dose 2 to first Grade ≥3 local reaction was not estimable. The mean time (SD) from fi rst to 
last Grade ≥3 local reaction was not estimable ( Table 14.3.1-1.5.1-3 ).
After Dose 1, except for 1 (17%) for the 3 μg dose group, there were no local reactions 
after Day 7. After Dose 2, except f or 1 (17%) for the 3 μg dose gr oup, there were no local 
reactions after Day 4. For the 3 μg dose group, there was at leas t 1 (10%) local reaction 
on each day thereafter up to Day 7.
The participant’s diary compliance for reporting local reaction s after Dose 1 was 100% up 
to Day 6 before dropping on Day 7 in some dose groups, while after  Dose 2 it was ≥95% 
up to Day 7 ( Table 14.3.2-1.2-3, Listing 16.2.3-1.2-3 ).
12.3.6.2 Older participants and all (younger and older) particip ants
The mean time (SD) from Dose 1 to first local reaction was 1.3 d (0.5), while the mean 
time (SD) from first local reaction to last local reaction was 2.0 d (1.3). The mean time from 
Dose 1 to first Grade ≥3 local reaction was not estimable. The mean time from first t o last 
Grade ≥3 local reaction was not estimable ( Table 14.3.1-1.5.1-3 ).
The mean time (SD) from Dose 2 to first local reaction was 1.2 d (0.4), while the mean 
time (SD) from first to last local reactions was 2.6 d (1.6). Th e mean time (SD) from 
Dose 2 to first Grade ≥3 local reaction was 2.0 d (not estimable [NE]). The mean time (SD) 
from first to last Grade ≥3 local reaction was 1.0 d ( NE) ( Table 14.3.1-1.5.1-3 ).
After Dose 1, except for 1 (14%) for the 10 μg dose group, there were no local reactions 
after Day 4. For the 3 μg dose gro up, there was at least 1 (14%) local reaction on each 
day thereafter up to Day 7. After D ose 2, except for 2 (29%) for the 3 μg dose group, there 
were no local reactions after Day 4. For the 3 μg dose group, the re was at least 12 (29%) 
local reactions on each day thereafter up to Day 7.After Dose 1 and Dose 2, for almost all participants, except for 4 (5%) and 12 participants 
(18%) respectively, the local reactions resolved within 2 d ( Table 14.3.1-1.6.1-3 ).
The participant’s diary compliance for reporting local reaction s after Dose 1 was 100% up 
to Day 5 before dropping on Days 6 and 7 in some dose groups, while after Dose 2 it was 
≥96% on Day 5 before dropping on Days 6 and 7 in some dose groups ( Table 14.3.2-1.2-
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Descriptive statistics of time of solicited local and any solic ited reactions by term is 
presented in Table 14.3.1-1.5.2-3 . A summary of solicited local reactions reported by 
participants (who completed doses 1 and 2) within 7 d after each  dose is presented in
Table 14.3.1-1.2-3 . An overview of solicited local reactions by severity reported  by 
participants (who completed doses  1 and 2) within 7 d after each  dose is presented in 
Table 14.3.1-1.4-3 .
Solicited systemic reactions
Solicited systemic reactions within 7 d after each BNT162b1 dose
A summary of solicited systemic reactions is presented in Table 23 . All solicited systemic 
reaction data by participant is given in Listing 16.2.3-1.3-1 .
12.4.1.1 Younger participants
Within 7 d days after Dose 1;
xApproximately 85% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
xIn total 19 participants reported Grade ≥3 systemic reactions.
xA possible dose dependency for Grade ≥3 systemic reactions between the 10 μg
group (1 participant) and the 20 μg, 30 μg, 50 μg, and 60 μg groups (2, 3, 5, and 8 
participants, respectively) was seen.
Within 7 d after Dose 2;
xApproximately 80% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
xIn total 25 participants reported Grade ≥3 systemic reactions.
xNo dose dependency for Grade ≥3 systemic reactions as the 10 μg and 20 μg groups 
have 5 participants each, the 30 μg groups 6 participants) and th e 50 μg group has 
5 participants. The Dose 2 in the 60 μg group was omitted due to the SRC decision.
Across the 2 intervals combined 77 participants (92%) reported any systemic reaction at any dose, of which 37 (44%) participants reported Grade ≥3 with a possible dose 
dependency between 10 μg (6 participants), 20 μg (5 participants), 30 μg (6 participants),and 50 μg (8 participants) and 60 μg (8 participants) dose groups.
12.4.1.2 Older participants and all (younger and older) particip ants
Within 7 d days after Dose 1;
xApproximately 86% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
xIn total 4 participants reported Grade ≥3 systemic reactions.
xNo dose dependency for Grade ≥3 systemic reactions between the 10 μg and 20 μg
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Solicited systemic reactions by severity –BNT162b1
A summary of participants with solicited systemic reactions by severity is given in Table 24
(younger participants) and Table 25 (older participants). The frequency of participants with 
solicited systemic reactions by term per day is presented in Table 14.3.1-2.6.2-1 .
12.4.2.1 Younger participants
Overall, in the combined time int erval, after both doses, the m ajority of the participants 
experienced mild (n=76, 90%) follo wed by moderate (n=62, 74%) s olicited systemic 
reactions. A few participants ex perienced severe (n=37, 44%) solicited systemic reactions.
xThe most frequent severe systemic  reactions were reported in 50 μg and 60 μg
groups (8 participants each [67%]) followed by 10 μg and 30 μg (6 participants each 
[50%]) groups.
xThe most frequently reported solicited systemic reactions of an y severity were fatigue 
(n=68, 81%), headache (n=66, 79%), myalgia (n=51, 61%), malaise  (n=50, 60%), and 
chills (n=47, 56%). The remaining symptom terms were less freque nt.
xFor nausea, vomiting, diarrhoea, myalgia, arthralgia and fever each symptom was assessed as severe in ≤10% of participants.
xA possible dose dependency for both severe headache and chills was seen with 2 participants at 10 μg vs. 6 parti cipants at 50 μg and 3 participant s at 10 μg vs. 5 
participants at 50 μg, respectively. A possible dose dependency for both severe fatigue and loss of appetite was  seen with each 1 participant at  10 μg vs. 4 
participants at 50 μg, respectively.
xNo clear pattern of dose dependency was seen across the symptom  terms for mild or 
moderate reactions, with the exception of moderate intensity ma laise which was 
reported for 17% of participants at 10 μg vs. 75% of participants a t5 0μ g .
12.4.2.2 Older participants and all (younger and older) particip ants
Overall, in the combined time int erval, after both doses, the m ajority of the participants 
experienced mild (n=32, 89%) followed by moderate (n=22, 61%) sol icited systemic 
reactions. A few participants ex perienced severe (n=10, 28%) sol icited systemic reactions.
xThe most frequent severe systemic  reactions were reported in th e 30 μg group 
(5 participants, 42%) followed by 20 μg (3 participants, 25%) and 10 μg
(2 participants, 17%) groups.
xThe most frequently reported solicited systemic reactions of an y severity were 
headache (n=29, 81%), fatigue (n=27, 75%), myalgia (n=18, 50%), an d malaise 
(n=18, 50%). The remaining symptom terms were less frequent.
xNo clear pattern of dose dependency was seen across the symptom  terms for mild, 
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≥92% up to Day 5 before dropping on Days 6 and 7 in some dose groups (Table 14.3.2-
1.3-1 ,Listing 16.2.3-1.4-1 ).
12.4.3.2 Older participants and all (younger and older) particip ants
The mean time (SD) from Dose 1 to first systemic reaction was 1.5 d (0.6), while the mean 
time (SD) from first to last systemic reaction was 2.6 d (1.8). The mean time (SD) from 
Dose 1 to first Grade ≥3 systemic reaction was 1.5 d (0.6). The mean time (SD) from first 
to last Grade ≥3 systemic reaction was 1. 0d  ( 0 . 0 )  ( Table 14.3.1-2.5.1-1 ).
The mean time (SD) from Dose 2 to first systemic reaction was 1.2 d (0.4), while the mean 
time (SD) from first to last systemic reaction was 3.0 d (1.7). The mean time (SD) from 
Dose 2 to first Grade ≥3 systemic reaction was 1.3 d (0.5). The mean time (SD) from first 
to last Grade ≥3 systemic reaction was 1.4 d (0.5) ( Table 14.3.1-2.5.1-1 ).
After Dose 1 there were no systemic reactions on Day 7. After Dose 2, except for 1 (10%) for the 20 μg dose group, there we re no systemic reactions on Da y7(Table 14.3.1-2.6.1-
1).
The participant’s diary compliance for reporting systemic react ions after Dose 1 was 100%
up to Day 6 before dropping on Day 7 in some dose groups, while af ter Dose 2 it was 
≥92% up to Day 5 before dropping on Days 6 and 7 in some dose groups  (Table 14.3.2-
1.3-1 ,Listing 16.2.3-1.4-1 ).
Descriptive statistics of time of solicited systemic reactions by term is presented in 
Table 14.3.1-2.5.2-1 . A summary of solicited systemic reactions reported by partici pants 
(who completed doses 1 and 2) within 7 d after each dose is presented in Table 14.3.1-
2.2-1 . An overview of solicited systemic reactions by severity exper ienced by participants 
who completed both the doses is presented in Table 14.3.1-2.4-1 .
Solicited systemic reactions within 7 d after each BNT162b2 dose
A summary of solicited systemic reactions is presented in  Table 26 . All solicited systemic 
reaction data by participant is given in Listing 16.2.3-1.3-3 .
12.4.4.1 Younger participants
Within 7 d after Dose 1;
xApproximately 80% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
xThere was only 1 participant in the 20 μg group for whom a Grade ≥3 systemic 
reaction was reported.
xNo dose dependency was apparent for any or high-grade systemic reactions.
Within 7 d after Dose 2;
xApproximately 57% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
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xA dose dependency was seen across  all grades of systemic reacti ons.
xA possible dose dependency for Grade ≥3 systemic reactions between the 10 μg
group (1 participant) and 30 μg gr oup (3 participants) was seen.
xAcross the 2 intervals combined 88% of participants reported an y systemic reaction 
at any dose, of which 6 participants reported Grade ≥3 with a possible dose 
dependency between 10 μg and higher doses.
xThe 30 μg dose (selected for ongoing development) demonstrated si milar tolerability 
to the 20 μg dose.
12.4.4.2 Older participants and all (younger and older) particip ants
Within 7 d after Dose 1;
xApproximately 44% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
xThere was only 1 participant in the 10 μg group for whom a Grade ≥3 systemic 
reaction was reported.
xNo dose dependency was apparent for any or high-grade systemic reactions.
Within 7 d after Dose 2;
xApproximately 64% of participants reported at least one systemi c reaction of any 
grade on at least one occasion.
xThree participants reported a Grade ≥3 systemic reaction.
xA dose dependency was seen across  all grades of systemic reacti ons.
xA possible dose dependency for Grade ≥3 systemic reactions between the 10 μg
group (1 participant) and 30 μg gr oup (2 participants) was seen.
xAcross the 2 intervals combined 72% of participants reported an y systemic reaction 
at any dose, of which 4 participants reported Grade ≥3 with no dose dependency 
between 10 μg and higher doses.
xThe 30 μg dose (selected for ongoing development) demonstrated si milar tolerability 
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12.4.5.1 Younger participants
Overall, in the combined time interval after both doses, the ma jority of the younger 
participants experienced mild (n=53, 88%) followed by moderate (n=23, 38%) solicited 
systemic reactions. A few participants experienced severe (n=6, 10%) solicited systemic 
reactions.
xSevere grade systemic reactions were reported in 30 μg (3 particip ants [25%]), 20 μg
(2 participants [17%]), and 10 μg (1 participant [8%]) dose groups.
xThe most frequently reported solicited systemic reactions of an y severity were fatigue 
(n=40, 67%), followed by headache (n =32, 53%), malaise (n=24, 40%), and myalgia 
(n=23, 38%). The remaining sympto m terms were less frequent.
xMost symptom terms reported were predominantly at mild intensit y with a ratio of mild 
to moderate reports of between 3:1 and 2:1.
xOnly mild reactions were reported for diarrhoea and fever.
xFor nausea, headache, fatigue, myalgia, chills, arthralgia and malaise each symptom 
was assessed as severe in <10% of participants.
xA possible dose dependency for both severe fatigue and arthralg ia was seen with 
0 participants at 10 μg vs. 2 participants at 30 μg, and 0 participants at 10 μg vs. 3 participants at 30 μg, respectively.
xSimilarly, no clear pattern of dose dependency was seen across the symptom terms 
for mild reactions or moderate reactions, with the exception of  moderate intensity 
malaise which was reported for 1 participant receiving 10 μg and 6 p articipants with 
30 μg dose.
xFor the 30 μg dose selected for further development, there were c onsistently slightly 
higher rates of reporting systemic reactions than for the next lowest 20 μg level for every individual symptom term ex cept headache, diarrhoea, fatigu e, and fever. The 
difference is pronounced for malaise 33% (20 μg) vs. 58% (30 μg) and arthralgia 17% (20 μg) vs. 50% (30 μg).
xNo major differences were noted between the pattern seen for th e combined time 
intervals and the individual reporting period.
12.4.5.2 Older participants and all (younger and older) particip ants
Overall, in the combined time interval after both doses, the ma jority of the older 
participants experienced mild (n=25, 69%) followed by moderate ( n=13, 36%) solicited 
systemic reactions. A few participants experienced severe (n=4,  11%) solicited systemic 
reactions.
xSevere grade systemic reactions were reported in 30 μg (2 particip ants [17%]) and 
10 μg (2 participants [17%]) dose groups.
xThe most frequently reported solicited systemic reactions of an y severity were fatigue 
(n=20, 56%), followed by headache (n=17, 47%), malaise (n=12, 3 3%), and myalgia 
(n=12, 33%). The remaining symptom terms were less frequent.090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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xMost symptom terms reported were predominantly at mild intensit y with a ratio of mild 
to moderate reports of between 3:1 and 2:1.
xOnly mild reactions were reported for diarrhoea and fever.
xAll symptoms were assessed as severe in <10% of participants.
xFor the 30 μg dose selected for further development, there were c onsistently slightly 
higher rates of reporting system ic reactions than for the next lowest 20 μg level for 
every individual symptom term. The difference is pronounced for  moderate malaise 
8% (20 μg) vs. 50% (30 μg).
xNo major differences were noted between the pattern seen for th e combined time 
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Time to onset and duration of systemic reactions –BNT162b2
12.4.6.1 Younger participants
The mean time (SD) from Dose 1 to first systemic reaction was 1.8 d (1.6), while the mean 
time (SD) from first to last systemic reaction was 2.6 d (2.1). The mean time (SD) from 
Dose 1 to first Grade ≥3systemic reaction was 2.0 d (NE). The mean time (SD) from first 
to last Grade ≥3systemic reaction was 1.0 d (NE) ( Table 14.3.1-2.5.1-3 ).
The mean time (SD) from Dose 2 to first systemic reaction was 1.3 d (0.5), while the mean 
time (SD) from first to last systemic reaction was 2.7 d (2.2). The mean time (SD) from 
Dose 2 to first Grade ≥3systemic reaction was 2.2 d (1.1). The mean time (SD) from first  
to last Grade ≥3systemic reaction was 1.2 d (0.4) ( Table 14.3.1-2.5.1-3 ).
After Dose 1 and Dose 2, for almost all participants, except for 2 ( 4%) and 2 participants 
(6%) respectively, the systemic reactions resolved within 7 d ( Table 14.3.1-2.6.1-3 ).
The participant’s diary compliance for reporting systemic react ions after Dose 1 was 100% 
up to Day 6 before dropping in some dose groups on Day 7, while af ter Dose 2 it was 
100% in all but one dose group (1 μg) up to Day 6 before dropping in some dose groups 
on Day 7 ( Table 14.3.2-1.3-3 ,Listing 16.2.3-1.4-3 ).
12.4.6.2 Older participants and all (younger and older) particip ants
The mean time (SD) from Dose 1 to first systemic reaction was 1.6 d (0.9), while the mean 
time (SD) from first to last systemic reaction was 2.9 d (2.4). The mean time (SD) from 
Dose 1 to first Grade ≥3systemic reaction was 1.0 d (NE). The mean time (SD) from first 
to last Grade ≥3systemic reaction was 1.0 d (NE) ( Table 14.3.1-2.5.1-3 ).
The mean time (SD) from Dose 2 to first systemic reaction was 1.5 d (1.3), while the mean 
time (SD) from first to last systemic reaction was 2.2 d (1.5). The mean time (SD) from 
Dose 2 to first Grade ≥3systemic reaction was 1.3 d (0.6). The mean time (SD) from first  
to last Grade ≥3systemic reaction was 1.3 d (0.6) ( Table 14.3.1-2.5.1-3 ).
After Dose 1 and Dose 2, for almost all participants, except for 2 (3 %) and 2 participants 
(4%) respectively, the systemic reactions resolved within 7 d ( Table 14.3.1-2.6.1-3 ).
The participant’s diary compliance for reporting systemic react ions after Dose 1 was 100% 
up to Day 6 before dropping in some dose groups on Day 7, while aft er Dose 2 it was 
100% up to Day 5 before dropping in some dose groups on Days 6 and 7 (Table 14.3.2-
1.3-3 ,Listing 16.2.3-1.4-3 ).
Descriptive statistics of time of solicited systemic reactions by term is presented in 
Table 14.3.1-2.5.2-3 . A summary of solicited systemic  reactions reported by particip ants 
(who completed doses 1 and 2) within 7 d after each dose is presented in Table 14.3.1-
2.2-3 . A summary of participants (who completed doses 1 and 2) with solicited systemic 
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Adverse events
Overview of adverse events
12.5.1.1 Unsolicited TEAEs after BNT162b1 dosing
A summary of unsolicited TEAEs without AEs based on solicited r eporting via diaries is
presented in Table 29 (Safety Set) and Table 30 (SAFB) for the younger participants and 
inTable 31 (Safety Set) and Table 32 (SAFB) for the older participants. All unsolicited 
TEAEs data by participant is given in Listing 16.2.3-1.6-1 .
12.5.1.1.1 Younger participants
Within 7 d after Dose 1, 16 participants (19%) experienced in tota l 24 TEAEs of which 23 
events were related TEAEs, except for one TEAE reported in 1 μg d ose group ( Table 29 ).
xSix participants (50%) in 60 μg reported in total 8 TEAEs, 3 partici pants (25%) in 
10 μg reported in total 7 TEAEs, 3 participants (25%) in 20 μg report ed in total 
4 TEAEs, 2 participants (17%) in 30 μg reported in total 2 TEAEs, 1 participant (8%)
in 50 μg reported in total 1 TEAE.
xNone of the participants reported any TEAEs with Grade ≥3severity.
Within 28 d after Dose 1 or up to Dose 2, 21 participants (25%) expe rienced in total 
39 TEAEs of which, 24 events were related TEAEs ( Table 29 ).
xSix participants (50%) in 60 μg reported in total 9 TEAEs, 4 partici pants (33%) in 
10 μg reported in total 11 TEAEs, 4 participants (33%) in 30 μg repor ted in total 
5 TEAEs, 3 participants each (25%) in 50 μg and 20 μg reported in total 4 TEAEs.
xOf which, 24 events were related TEAEs. Of which, 6 participants (50%) in 60 μgreported in total 8 related TEAEs, 3 participants (25%) in 10 μg rep orted in total 7
related TEAEs, 3 participants (25%) in 20 μg reported in total 4 re lated TEAEs, 
3 participants (25%) in 30 μg reported in total 3 related TEAEs, 1 participant (8%) in 50 μg reported in total 1 related TEAE.
xNone of the participants reported any TEAEs with Grade ≥3severity.
Within 7 d after Dose 2 in the SAFB, 18 participants (26%) experienc ed in total 34 TEAEs
of which, 27 events were related TEAEs ( Table 30 ).
xSix participants (55%) in 50 μg reported in total 10 TEAEs, 3 participants (27%) in 10 μg reported in total 3 TEAEs, 3 participants (27%) in 20 μg reporte d in total 
8 TEAEs, and 1 participant (8%) in 30 μg reported in total 1 TEAE. The Dose 2 in the 
60 μg group was omitted due to the SRC decision, hence the result s are unavailable.
xFive participants (45%) in 50 μg reported in total 9 related TEAEs, 3 participants 
(27%) in 10 μg reported in total 3 related TEAEs, 2 participants (18 %) in 20 μg
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xTwo participants in the 20 μg group reported 4 TEAEs with Grade ≥3 severity, of 
which 1 participant (9%) reported in total 3 related Grade ≥3 TE AEs.
Within 28 d after Dose 2 in the SAFB, 22 participants (32%) experien ced in total 45 TEAEs
of which, 28 events were related TEAEs ( Table 30 ).
xSix participants (55%) in 50 μg reported in total 13 TEAEs, 4 partic ipants (36%) in 
10 μg reported in total 5 TEAEs, 3 participants (27%) in 20 μg repor ted in total 
8 TEAEs, and 3 participants (25%) in 30 μg reported in total 4 TEAEs.
xOf which, 5 participants (45%) in 50 μg reported in total 9 related TEAEs, 
3 participants (27%) in 10 μg reported in total 3 related TEAEs, 2 p articipants (17%)
in 30 μg dose groups reported in total 2 related TEAEs, and 2 partic ipants (18%) in 
20 μg dose groups reported in total 5 related TEAEs.
xTwo participants in the 20 μg group reported 4 TEAEs with Grade ≥3severity, of 
which 1 participant (9%) reported in total 3 related Grade ≥3 T EAEs .
Within 28 d after Dose 1 or Dose 2, 38 participants (45%) experienced  in total 83 TEAEs
of which 51 events were related TEAEs ( Table 29 ).
xEight participants (67%) in 50 μg re ported in total 17 TEAEs, 7 participants (58%) in 
10 μg reported in total 16 TEAEs, 6 participants (50%) in 60 μg repor ted in total 
9 TEAEs, 6 participants (50%) in 30 μg reported in total 8 TEAEs, and 5 participants 
(42%) in 20 μg reported in total 12 TEAEs.
xSix participants (50%) in 10 μg reported in total 10 related TEAEs, 6 participants 
(50%) in 50 μg reported in total 10 related TEAEs, 6 participants ( 50%) in 60 μg 
reported in total 8 related TEAEs, 4 participants (33%) in 20 μg re ported in total 
9 related TEAEs, 4 participants (33%) in 30 μg reported in total 4 r elated TEAEs.
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xOne participant (8%) reported one Grade ≥3TEAE in 10 μg group.
Within 7 d after Dose 2, 9 participants (15%) experienced in total 14 TEAEs of which 6 
events were related TEAEs.
xThree participants (25%) in 10 μg re ported in total 3 TEAEs, 1 parti cipant (8%) in 
30 μg reported in total 3 TEAEs, 1 participant (8%) in 20 μg reported in total 2 TEAEs.
xOf which, 6 events were related TEAEs; 1 participant (8%) in 30 μg r eported in total 
3 TEAEs, 1 participant (8%) in 20 μg reported in total 2 TEAEs, 1 par ticipant (8%) in 
10 μg reported in total 1 TEAE.
xNone of the participants reported any TEAEs with Grade ≥3severity.
Within 28 d after Dose 2, 15 participants (25%) experienced in tota l 25 TEAEs of which 7 
events were related TEAEs.
xFour participants (33%) in 10 μg reported in total 4 TEAEs, 1 partic ipant (8%) in 30 μg
reported in total 3 TEAEs, 1 participant (8%) in 20 μg reported in total 2 TEAEs.
xOf which, 7 events were related TEAEs; 1 participant (8%) in 30 μg reported in total 
3 TEAEs, 1 participant (8%) in 20 μg reported in total 2 TEAEs, 1 par ticipant (8%) in 
10 μg reported in total 1 TEAE.
xNone of the participants reported any TEAEs with Grade ≥3severity.
Within 28 d after Dose 1 or Dose 2, 26 participants (43%) experienced  in total 51 TEAEs
of which, 9 events were related TEAEs.
xSeven participants (58%) in 10 μg reported in total 11 TEAEs, 5 part icipants (42%) in 
30 μg reported in total 8 TEAEs, 2 participants (17%) in 20 μg report ed in total 
3 TEAEs.
xOf which, 9 events were related TEAEs; 1 participant (8%) in 30 μg reported in total 3 TEAEs, 1 participant (8%) in 20 μg reported in total 2 TEAEs, 1 par ticipant (8%) in 
10 μg reported in total 1 TEAE.
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12.5.1.2.2 Older participants and all (younger and older) partic ipants
Within 7 d after Dose 1, 6 participants (17%) experienced in total 9 TEAEs of which 
1 event was a related TEAE in the 30 μg group.
xTwo participants (17%) in 30 μg reported in total 4 TEAEs, 2 partici pants (17%) in 
20 μg reported in total 3 TEAEs, 2 participants (17%) in 10 μg repor ted in total 
2 TEAEs.
xOne participant (8%) in 30 μg reported in total 1 TEAE with Grade ≥3severity.
Within 28 d after Dose 1 or up to Dose 2, 8 participants (22%) experienced in total 
13 TEAEs of which 4 events were related TEAEs.
xThree participants (25%) in 10 μg and 30 μg reported in total 5 TEAEs  and 2 
participants (17%) in 20 μg reported in total 3 TEAEs.
xTwo participants (17%) reported 2 Grade ≥3TEAEs (of which 1 was related) in 30 μg
group.
Within 7 d after Dose 2, 1 participant (8%) in the 30 μg group experien ced in total 1 not 
related TEAE.
Within 28 d after Dose 2, 5 participants (14%) experienced in total 7 not related TEAEs.
xOne participant reported a TESAE (ankle fracture).
Within 28 d after Dose 1 or Dose 2, 12 participants (33%) experienced  in total 20 TEAEs 
of which 4 events were related TEAEs.
xThree participants (25%) in 30 μg reported in total 6 TEAEs, 6 parti cipants (50%) in 
20 μg reported in total 9 TEAEs and 3 participants (25%) in 10 μg repo rted in total 
5 TEAEs.
xTwo participants in the 30 μg group reported 2 Grade ≥3 TEAEs and o ne participant 
(8%) in 20 μg group reported one Grade ≥3TEAE.
xOne participant reported a not related TESAE (ankle fracture) in  20 μg group.090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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Analysis of adverse events
12.5.2.1 Frequency of TEAEs by SOC and PT
12.5.2.1.1 BNT162b112.5.2.1.1.1 Younger participants
Table 35 presents the frequency of participants with TEAEs by SOC and PT  (Dose 1 up to 
Day 28 after Dose 2 or Dose 1). The most frequently reported SOCs ( ≥10%) were:
x“General disorders and administration site conditions” reported  by 9 participants 
(11%):
oAmongst which following PTs were most frequently reported: inje ction site 
reactions (n=5, 6%), influenza lik e illness and injection site he matoma (each, 
n=2, 2%).
x“Nervous system disorder s” reported by 10 participants (12%):
oAmongst which following PTs were most frequently reported: headac he (n=4,
5%) and presyncope (n=3, 4%).
oThere were only single cases of hyperaesthesia and paraesthesia .
x“Respiratory, thoracic and mediastinal disorders” reported by 9 participants (11%):
oAmongst which following PTs were most frequently reported: coug ha n d
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xWithin 7 d after Dose 1, 1 participant (1%): PT reported was pyrexia (n=1, 8%) in 
60 μg group.
xWithin 28 d after Dose 1 or up to Dose 2, 1 participant (1%): PT repor ted was pyrexia 
(n=1, 8%) in 60 μg group and headache (n=1, 8%) in 60 μg group.
xWithin 7 d after Dose 2, 3 participants (2 participants in 50 μg grou p and 1 in 10 μg
group): PT reported was influenza like illness (n=3, 4%).
xWithin 28 d after Dose 2, 3 participants (2 participants in 50 μg grou p and 1 in 10 μg
group): PT reported was influenza like illness (n=3, 4%).
xWithin 28 d after Dose 1 or Dose 2, 4 participants (5%): PTs reported were influenza 
like illness (n=2 in 50 μg group and n=1 in 10 μg) and pyrexia (n= 1, 8%) in 60 μg
group.
While from the SOC “ Nervous system disorders ”; Grade ≥3headache was experienced by 
1 participant in the 20 μg group, which was assessed as not relate d.
In the older participants group, no TEAEs with Grade ≥3and related to IMP were reported 
(Table 14.3.1-3.2.3-1 and Table 14.3.1-3.2.4-1 ). the most frequently reported SOC with 
Grade ≥3 TEAEs was “Nervous system disorders”.
xWithin 28 d after Dose 1, 1 participant (1%): PT reported was mig raine (n=1, 8%) in 
10 μg group and 1 participant: PT reported was syncope (n=1, 8%) in the 20 μg
group.
xWithin 28 d after Dose 1 or Dose 2, 1 participant (1%): PT reported was migraine 
(n=1, 8%) in 10 μg group and 1 participant: PT reported was synco pe (n=1, 8%) in 
the 20 μg group.
The frequency of participants with TEAEs by worst grade, SOC an d PT is presented in 
Table 14.3.1-3.5.1-1 .
12.5.2.2.2 BNT162b2
In the younger participants group, the most frequently reported  SOC with Grade ≥3TEAEs 
was “Musculoskeletal and connective tissue disorder ” (Table 14.3.1-3.2.3-3 ).
xThe most frequently reported PT was neck pain (n=1, 2%) in the 1 0 μg group.
None of the Grade ≥3TEAEs were assessed as related to the IMP ( Table 14.3.1-3.2.4-3 ).
In the older participants group, the most frequently reported S OC with Grade ≥3TEAEs 
was “Nervous system disorders” ( Table 14.3.1-3.2.3-3 ).
xThe reported PTs were headache in 1 participant (3%) and orthos tatic intolerance in 
1 participant (3%) in the 30 μg group.
None of the Grade ≥3TEAEs were assessed as related to the IMP ( Table 14.3.1-3.2.4-3 ).
The frequency of participants with TEAEs by worst grade, SOC an d PT is presented in 
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12.5.2.3 Relationship of TEAEs to IMP
12.5.2.3.1 BNT162b1
In the younger participants, in th e Safety Set, Dose 2 up to Day 28  after Dose 2, the most 
frequently reported related SOCs were:
x“General disorders and administration site conditions” were reported by 40 
participants (48%):
oAmongst which the following PTs were most frequently reported: influenza like 
illness (n=32, 38%), injection site  reaction (n=29, 35%), and in jection site 
discomfort (n=7, 8%) ( Table 14.3.1-3.2.2-1 ).
x“Nervous system disorder s” reported by 16 participants (19%):
oAmongst which following PT was most frequently reported headach e (n=11, 
13%) ( Table 14.3.1-3.2.2-1 ).
x“Musculoskeletal and connective tissue disorders” reported by 5 participants (6%):
oAmongst which following PTs was most frequently reported myalgia (n=2, 2%),
(Table 14.3.1-3.2.2-1 ).
xIn the older participants, in th e Safety Set, Dose 2 up to Day 28 after Dose 2, one 
related TEAE was reported in the 30 μg group in each of the following SOCs: “Ear 
and labyrinth disorders”, Gastrointestinal disorders”, “and “Urinary disorders” (Table 14.3.1-3.2.2-1 ).
12.5.2.3.2 BNT162b2
In the younger participants, in th e Safety Set, Dose 2 up to Day 28  after Dose 2, the most 
frequently reported related SOC was:
x“General disorders and administration site conditions” reported  by 10 participants 
(17%):
oAmongst which the most frequently reported PTs were injection site  reaction 
(n=10, 17%) and influenza like illness (n=4, 7%) ( Table 14.3.1-3.2.2-3).
xIn the older participants, in th e Safety Set, Dose 2 up to Day 28 after Dose 2, the only 
reported related SOC was:
x“Vascular disorders” reported by 1 participant (3%) with the PT  of hot flush.
12.5.2.4 Outcome of TEAEs
None of the reported TEAEs were unresolved ( Table 14.3.1-3.2.7-1 [BNT162b1] and 
Table 14.3.1-3.2.7-3 [BNT162b2]).
Listing of AEs by participant
Listings of AEs by participant are presented in Listing 16.2.3-1.5-1 (BNT162b1) and 
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Deaths, other SAEs, and other significant AEs
BNT162b1
12.6.1.1 Younger participants
One participant discontinued due to a moderate AE (malaise) from the study; a detailed 
narrative is given below. There were no deaths ( Table 14.3.1-3.2.7-1 ), other TESAEs 
(Table 14.3.1-3.2.5-1 ,Table 14.3.1-3.2.6-1 , and Table 14.3.1-3.7.1-1 ), TEAEs of special 
interest ( Table 14.3.1-3.1.4-1 ), or other significant AEs, repo rted at the cut-off dates for 
this report.Participant 10010 was a 53-yr-old White female ( Listing 16.2.1-5-1). The participant was 
enrolled into the study on 22 APR 2020 and received Dose 1 (10 μg) on 2 4 APR 2020
(Listing 16.2.1-1-1 ). On the same Day (24 APR 2020) the participant experienced mild 
tiredness and fatigue. Both the events resolved (tiredness and fatigue) without medication 
on 07 MAY 2020 and were assessed as related to the IMP by the inv estigator. On 
12 MAY 2020 the participant experienced malaise, myalgia, chills, and pyrexia (fever up to 
39.3°C). The events (malaise, chills, and pyrexia) were moderate in  severity, while myalgia 
was mild in severity. These events were assessed as not related  to the IMP by the 
investigator. The event (chills) resolved on 13 MAY 2020 without medication while the 
event (pyrexia) resolved on 14 MAY 2020 with medication. The even ts (malaise and 
myalgia) resolved with medication on 16 MAY 2020 ( Listing 16.2.3-1.3-1 ). On 
19 MAY 2020, the participant withdrew from the study due to the eve nt (malaise) 
(Listing 16.2.3-1.3-1 and Listing 16.2.1-3-1 ).
One participant discontinued the study IMP due to dose limiting  toxicity; a detailed 
narrative for this participant is given below.Participant 10075 was a 27-yr-old White female ( Listing 16.2.1-5-1 ). The participant was 
enrolled into the study on 11 May 2020 and received Dose 1 (60 μg) o n 22 MAY 2020 
(Listing 16.2.1-1-1 ). On the same Day (22 MAY 2020) the participant experienced mild 
flatulence and ear pain, moderate headache, influenza like illne ss and injection site 
reactions and severe pyrexia (39.2°C). All these events were asse ssed as TEAEs and 
related to the IMP. The event pyrexia qualified as a dose limiti ng toxicity. It was 
determined the participant should not receive their Dose 2 and as a result the IMP was 
withdrawn on the same day. The events (flatulence, pyrexia, and ear pain) resolved on 
24 May 2020 without medication, exc ept for pyrexia, which resolved with medication. The 
event (influenza like illness) resolved on 26 MAY 2020 without medication. The event 
(headache) resolved on 27 MAY 2020 with medication, while injection site reactions 
resolved on 28 MAY 2020 without medication (Listing 16.2.3-1.3-1 ).
12.6.1.2 Older participants and all (younger and older) participa nts
In the Safety Set, Dose 1 up to Dose 2 or Day 28 after Dose 1, 1 part icipant (8%) had a 
serious not related TEAE in the SOC of “Nervous system disorders” . This was an event of 
syncope in the 20 μg group ( Table 14.3.1-3.2.5-1 ,Table 14.3.1-3.2.6-1 , and Listing 14.3.1-
3.7.1-1 ). A detailed narrative is given below.090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT )
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There were no deaths ( Table 14.3.1-3.2.7-1 ), TEAEs of special interest
(Table 14.3.1-3.1.4-1 ), or other significant AEs, reported at the cut-off dates for this report.
Participant 20242 was a 70-yr-old White female ( Listing 16.2.1-5-1 ). The participant was
enrolled into the study on 28 AUG 2020 and received Dose 1 (20 μg) on 09 SEP 2020
(Listing 16.2.1-1-1 ). On 18 SEP 2020, the participant experienced moderate left costa l 
arch and shoulder pain which is ongoing and medication is provi ded. This event was 
assessed as a TEAE but not related to the IMP. On 20 SEP 2020, th e participant 
experienced treatment-emergent SAE of severe syncope which was not related to IMP. On 
24 SEP 2020 the IMP was withdrawn (Dose 2 was not given).
BNT162b2
12.6.2.1 Younger participants
One participant discontinued due to a moderate AE (nasopharyngiti s) from the study and 
detailed narrative is given below. There were no deaths ( Table 14.3.1-3.2.7-3 ), other 
TESAEs ( Table 14.3.1-3.2.5-3 ,Table14.3.1-3.2.6-3 ,a n d Listing 14.3.1-3.7.1-3 ), TEAEs of 
special interest ( Table 14.3.1-3.1.4-3 ), or other significant AEs, reported at the cut-off 
dates for this report.
Participant 20116 was a 23-yr-old White female ( Listing 16.2.1-5-3 ). The participant was 
enrolled into the study on 20 MAY 2020 and received Dose 1 (10 μg) o n 18 JUN 2020 
(Listing 16.2.1-1-3 ). On 21 JUN 2020 the participant experienced mild external ear 
inflammation which resolved with medication on 28 JUN 2020. The e vent (external ear 
inflammation) was assessed as a TEAE but not related to the IMP.  On 04 JUL 2020, the 
participant experienced moderate nasopharyngitis which resolved  with medication on 
22 JUL 2020. This event was assessed as a TEAE but not related to the IMP. Due to the
event (nasopharyngitis) the participant withdrew from the study on 16 JUL 2020(Listing 16.2.3-1.3-3 ).
12.6.2.2 Older participants and all (younger and older) participa nts
In the Safety Set, Dose 1 up to Dose 2 or Day 28 after Dose 1, one p articipant (8%) had a 
serious not related TEAE in the SOC of “ Injury, poisoning and p rocedural complications ”. 
This was an event of ankle fracture in the 20 μg group (Table 14.3.1-3.2.5-3 ,Table 14.3.1-
3.2.6-3 , and Listing 14.3.1-3.7.1-3 ). A detailed narrative is given below.
There were no deaths ( Table 14.3.1-3.2.7-3 ), TEAEs of special interest 
(Table 14.3.1-3.1.4-3 ), or other significant AEs, reported at the cut-off dates for this report.
Participant 20215  was an 80-yr-old White female ( Listing 16.2.1-5-3). The participant was
enrolled into the study on 11 AUG 2020 and received Dose 1 (20 μg) o n 01 SEP 2020 and 
Dose 2 on 22 SEP 2020 ( Listing 16.2.1-1-3 ). On 14 OCT 2020, the participant experienced 
a moderate treatment-emergent SAE of ankle fracture which was n ot related to IMP. 
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Clinical laboratory evaluation
Listing of individual laboratory measurements by participant and
each abnormal laboratory value
A listing of individual laboratory measurements by participant an d each abnormal 
laboratory value is provided in Listing 16.2.3-2.2-1 (BNT162b1) and Listing 16.2.3-2.2-3
(BNT162b2).
Evaluation of each laboratory parameter
12.7.2.1 Hematology
The descriptive statistics for hematology parameters are present ed in Table 14.3.2-2.1.1-1
(BNT162b1) and Table 14.3.2-2.1.1-3 (BNT162b2).
Changes from baseline in lymphocyte (low) count were reported in all dose groups after 
48 h of dosing with both the IMPs (51 participants in BNT162b1 you nger participants [n=6 
in 10 μg, n=10 in 20 μg and 30 μg, n=11 in 50 μg, and n=10 in 60 μg groups  respectively],
28 participants in BNT162b1 older participants [n=7 in 10 μg, n=1 0 in 20 μg and n=11 in 
30 μg groups respectively), 16 participants in BNT162b2 younger par ticipants [n=2 in 
10 μg, n=7 in 20 μg, n=6 in 30 μg groups, respectively]) and 14 particip ants in the 
BNT162b2 older participants [n=3 in 10 μg, n=2 in 20 μg, n=9 in 30 μg groups, 
respectively]) as a pharmacodynamics effect (Table 14.3.2-2.5.1-1 and 
Table 14.3.2-2.5.1-3 , respectively). However, their values came back to normal at t he 
subsequent visit without any c linical consequence and without sequelae ( Table 39
[BNT162b1]) and ( Table 40 [BNT162b2]).
One participant (10018) in the BNT162b1 younger participants gr oup (1 μg) reported high 
lymphocyte count (4.33 x 109/L; normal 1.22 to 3.56 x 109/L) on Day 29 which was 
assessed as related mild TEAE and also as clinically significan t event. The event resolved 
8 d after the last dose (17 JUN 2020) without any medication ( Table 14.3.2-2.5.1-1 ,
Listings 16.2.3-1.3-1 ,16.2.3-1.5-1, and 16.2.3-2.2-1 [BNT162b1]).090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT )
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12.7.2.3 Urinalysis
The descriptive statistics for urinalysis parameters (continuou s) is presented in 
Table 14.3.2-2.1.3-1 (BNT162b1) and Table 14.3.2-2.1.3-3 (BNT162b2). The descriptive 
statistics for urinalysis parameters (categorical) is presented  in Table 14.3.2-2.1.4-1
(BNT162b1) and Table 14.3.2-2.1.4-3 (BNT162b2).
There were a few abnormal urinalysis parameters but none of the m were clinically 
significant except for one ( Table 14.3.2-2.5.3-1 [BNT162b1] and Table 14.3.2-2.5.3-3
[BNT162b2]). One younger participant in the 1 μg group had an elevat ed number of 
leukocytes at Day 50.
Individual clinically relevant abnormalities in clinical laboratory 
values
There were a few abnormal hematology parameters but none of the m were clinically 
relevant abnormalities ( Table 14.3.2-2.5.1-3 [BNT162b2]), except for one younger 
participant in the BNT162b1 (1 μg) who had a high lymphocyte count  (4.33 x 109/L; normal 
1.22- 3.56 x 109/L) on Day 29, 7 days after Dose 2, which was assessed as related TEAE 
and also as clinically significant event. The event resolved 8 d  after the last dose 
(17 JUN 2020) without any medication ( Table 14.3.2-2.5.1-1 ,Listing 16.2.3-1.3-1 and 
16.2.3-2.2-1 [BNT162b1]).
A few abnormal chemistry parameters were reported but none of th em were clinical 
relevant abnormalities, except for CRP reported on Day 2 by 2 par ticipants (3%) (n=1 each 
in 30 μg and 50 μg groups) for BNT162b1 ( Table 14.3.2-2.5.2-1 ) and on Day 8 by one 
participant (2%) (n=1 in 1 μg group) for BNT162b2 ( Table 14.3.2-2.5.2-3 ).
There were a few abnormal urinalysis parameters but none of the m were clinically relevant 
abnormalities ( Table 14.3.2-2.5.3-1 [BNT162b1] and Table 14.3.2-2.5.3-3 [BNT162b2]).
Vital signs, physical findings, and other observations related 
to safety
Vital signs
Descriptive statistics of vital signs data is given in Table 14.3.2-3.1-1 (BNT162b1) and 
Table 14.3.2-3.1-3 (BNT162b2).
A few abnormal vital signs were reported but none of them were clinical relevant 
abnormalities ( Table 14.3.2-3.3-3 [BNT162b2]), except for mild or moderate elevated body 
temperature reported on Day 2 by 5 younger participant participan ts (6%) in (n=1 each in 
30 μg and 50 μg groups and n=3 in 60 μg group) BNT162b1 group ( Table 14.3.2-3.3-1 ).
The events were assessed as related TEAEs. The elevated body tempe rature values 
came back to normal at the sub sequent visit with medication ( Table 14.3.2-3.3-1 and
Listing 16.2.3-2.3-1 ).
All vital signs data is given in Listing 16.2.3-2.3-1 (BNT162b1) and Listing 16.2.3-2.3-3
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12-lead electrocardiograms
Normal ECGs were a requirement for enrollment into this study. As judged by the 
investigator, no participants presented clinically significant ECG findings.
ECG data will be provided in a later update on this study.
Physical examination
Normal complete physical examinations were a requirement for en rollment into this study. 
As judged by the investigator, no enrolled participants presente d clinically significant 
physical examinations findings at screening or when assessed dur ing the ongoing study.
All physical examination data will be provided in a later update on this study.
Pregnancy
By the cut-off date for this report, there were no pregnancies reported in study participants 
(or their partners) in dose groups with BNT162b1 or BNT162b2 dos ing.
Safety conclusions
BNT162b1
xIn the younger participants group, 84 participants received Dos e1  w h i l e  6 9  
participants received Dose 2. In the older participants group, 3 6 participants received
Dose 1 and 35 participants received Dose 2.
xGenerally, good tolerability was observed. The majority of even ts reported were 
reactogenicity symptoms compared to TEAEs which were anticipate d for 
IM-administered vaccines, typically with an onset within first 2 4 h post-dose.
xIn the younger participants group, 72 participants (86%) experienced mild solicited 
local reactions, of which 15 participants (18%) experienced Grad e≥3 solicited local 
reactions with a possible dose de pendency between 10 μg (1 participant) and 20 μg
and 30 μg (2 and 5 participants) doses. The most frequently repor ted solicited local 
reaction was tenderness (n=70, 83%), followed by pain (n=67, 80 %). 
In the older participants group, 30 participants (83%) reported  any local reaction at 
any dose in the combined interval. No participants reported a G rade ≥3 local reaction. 
The most frequently reported solicited local reactions of any s everity were tenderness 
(n=28, 78%) and pain (n=27, 75%).
xIn the younger participants group, 77 participants (92%) experienced solicited 
systemic reactions, of which 37 participants (44%) experienced Grade ≥3 solicited 
systemic reactions with a possible dose dependency between 10 μg (6 participants), 
20 μg (5 participants), 30 μg (6 participants), and 50 μg (8 particip ants) and 60 μg (8
participants) dose groups. The most frequently reported solicited systemic reaction 
was fatigue (n=68, 81%), headache (n=66, 79%), myalgia (n=51, 6 1%), malaise 
(n=50, 60%), and chills (n=47, 56%). In the older participants group, 33 participants (92%) reported any systemic reaction 090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT )
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at any dose, of which 10 (28%) participants reported Grade ≥3 with a possible dose 
dependency between 10 μg and 20 μg (2 and 3 participants) and 30 μg
(5 participants), dose groups. The most frequently reported solicited systemic reactions of any severity were fatigue (n=27, 75%), and myalgia  (n=18, 50%).
xIn the younger participants group, 30 participants (43%) experienced in total 67 TEAEs, of which 39 events were related TEAEs. The most freque ntly reported
TEAEs were headache, influenza like illness, injection site rea ctions, cough, and 
oropharyngeal pain. In the older participants group, 12 participants (34%) experienc ed in total 21 TEAEs 
of which 9 were related TEAEs. The most frequently reported TEA Es were cough and 
oropharyngeal pain.
xIn the younger participants group, the most frequent Grade ≥3 T EAEs was influenza 
like illness experienced by 3 pa rticipants which was assessed a s related TEAE by the 
investigator.
xOne participant in the younger participants group discontinued the study due to 
malaise which was moderate in severity and assessed as not rela ted to the IMP.
xThere were no, deaths, TEAEs of special interest, or pregnancie s that led to 
withdrawal. One participant in the older participants group tre ated with 20 μg had a 
serious not related TEAE (severe syncope) and the IMP was withdra wn (Dose 2 was 
not given).
xChanges from baseline in lymphocyte (low) count were reported i n all dose groups 
after 48 h of dosing with both the IMPs (51 participants in the younger participants group and 28 participants in the older participants group).
xThere were no clinically relevant findings in urinalysis parame ters.
xTwo participants in the younger participants group experienced high CRP 48 h post-
dose. However, these values came back to normal without clinica l consequence at 
the subsequent visit.
xFive participants (8%) experienced elevated body temperature on  Day 2, which was 
assessed as related TEAE and th e event resolved at the subsequent visit with 
medication.
BNT162b2
xIn the younger participants group, 60 participants received Dos e1 ,  w h i l e  5 8  
participants received Dose 2. In the older participants group, 3 6 participants received 
both Dose 1 and Dose 2.
xGenerally, good tolerability was observed. The majority of even ts reported were 
reactogenicity symptoms compared to TEAEs which were anticipate d for 
IM-administered vaccines, typically with an onset within first 24 h post-dose.
xIn the younger participants group, 52 participants (87%) experie nced solicited local 
reactions, of which none of the participants reported Grade ≥3 local reactions. The 
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(each, n=45, 75%). 
In the older participants group, 31 participants (86%) reported  any local reaction at 
any dose, of which 2 participants (6%) reported Grade ≥3 local reactions. The most 
frequently reported solicited local reaction of any severity wa s mild tenderness (n=24, 
67%) followed by mild pain (n=22, 61%).
xIn the younger participants group, 53 participants (88%) experien ced solicited 
systemic reactions, of which 6 participants (10%) reported Grade ≥3 solicited 
systemic reactions with a possible dose dependency between 10 μg and higher 
doses. The most frequently reported solicited systemic reaction s were fatigue (n=40, 
67%), followed by headache (n=32,  53%), malaise (n=24, 40%), an d myalgia (n=23, 
38%). 
In the older participants group, 72% of participants reported a ny systemic reaction at 
any dose, of which 4 participants reported Grade ≥3 solicited systemic reactions. The 
most frequently reported solicited systemic reactions of any se verity were fatigue 
(n=20, 56%), followed by headache (n=17, 47%), malaise (n=12, 3 3%), and myalgia 
(n=12, 33%).
xThe frequency of local and systemic reactogenicity was generall y lower for 
BNT162b2 compared to BNT162b1. BNT162b2 generally had a milder and therefore 
more favorable reactogenicity profile than BNT162b1 across dose  levels.
xIn the younger participants group, 26 participants (43%) experie nced in total 51 
TEAEs, of which 9 events were related TEAEs. The most frequently reported TEAE was vessel puncture site pain. In the older participants group, 12 participants (33%) experienc ed in total 20 TEAEs 
of which 4 events were related TEAEs. The most frequently reported TEAE was back 
pain.
xIn the younger participants group, Grade ≥3 TEAEs were experien ced by 1 participant 
(2%) (neck pain) which was assessed as not related Grade ≥3 TEAE by the 
investigator. In the older participants group, Grade ≥3 TEAEs w ere experienced by 1 
participant (2%) (orthostatic intolerance) which was assessed a s not related Grade ≥3 
TEAE by the investigator.
xOne participant in the younger participants group discontinued the study due to 
nasopharyngitis which was moderate in severity and assessed as not related to the 
IMP.
xThere were no deaths, TEAEs of special interest, or pregnancies  that led to 
withdrawal reported. One participant in the older participants group treated with 20 μg
had a serious not related TEAE (ankle fracture).
xChanges from baseline in lymphocyte (low) count were reported i n all dose groups 
after 48 h of dosing with both the IMPs (16 participants in the younger participants 
group and 14 participants in the older participants group). The se values came back to 
normal values without any clinical consequence at the subsequent visit.090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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xThere were no clinically relevant changes in urinalysis or in c linical chemistry. One 
participant in the younger participants group had high CRP 48 h value post-dose that 
was back at normal value without clinical consequence at the sub sequent visit.
xThere were no clinically relevant  changes in vital signs during  the study.
13 DISCUSSION AND OVERALL CONCLUSIONS
This was an open-label, multi-site, Phase I/II, 2-part, dose-esc alation, first in human study 
evaluating the safety, tolerability, and immunogenicity of prop hylactic BNT162 vaccines 
against COVID-19 in healthy participants after two doses of IMP given ~21 d apart.
There were no changes in the conduct of the study considered by  the sponsor to either 
impact the study objectives or to have compromised participant safety. The IMP was 
administered by a physician, and thus the extent of exposure of  participants to the IMP 
was as expected and as stipulated in the protocol. There were s ome protocol deviations, 
none of these protocol deviations were considered to have affec ted the participant ’s safety 
or the objectives of the study.This report presents data for a population appropriate for a Phase I/II study with the first in
human dosing with BNT162b1 and BNT162b2, i.e., healthy younger participants (aged between 18 and 55 yrs), and data from a population of healthy ol der participants (aged 
between 56 and 85 yrs) who are at highest risk for COVID-19.
Safety
Primary safety endpoint
For BNT162b1, in the younger parti cipants group, a total of 72 p articipants (86%) reported 
solicited local reactions, of which 15 participants (18%) report ed Grade ≥3solicited local 
reactions with a possible dose dependency between 10 μg (1 partici pant) and 20 μg and 
30 μg (2 and 5 participants) doses. A total of 77 participants (92 %) reported solicited 
systemic reactions, of which 37 participants (44%) reported Grad e≥3solicited systemic 
reactions. A total of 38 participants (45%) reported in total 83 TEAEs, of which 51 events 
were related TEAEs. Two participants reported any Grade ≥3TEAEs. One participant who 
received (10 μg) vaccine withdrew from the study due to moderate malaise. There were no 
TESAEs or deaths.
In the older participants group, 30 participants (83%) reported  any local reaction at any 
dose in the combined interval. No participants reported a Grade ≥3local reaction. A total 
of 33 participants (92%) reported  any systemic reaction at any dose, of which 10 (28%)
participants reported Grade ≥3. A total of 13 participants (36%) experienced in total 
24 TEAEs of which 9 were related TEAEs. Four participants reported any Grade ≥3 
TEAEs. One participant in the older participants group had a serious not related TEAE 
(severe syncope). The IMP was withdrawn (Dose 2 was not given).
For BNT162b2, in the younger parti cipants group, a total of 52 pa rticipants (87%) reported 
solicited local reactions. A total of 53 participants (88%) repo rted solicited systemic 
reactions, of which 6 participants (10%) reported Grade ≥3solicited systemic reactions. A 
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TEAEs. Gr ade ≥3 TEAE was reported by one participant (2%) which was assessed as not 
related by the investigator. One participant who received (10 μg ) vaccine withdrew from 
the study due to moderate nasopharyngitis.
In the older participants group, 31 participants (86%) reported any local reaction at any 
dose, of which 2 participants (6%) reported Grade ≥3local reactions. 72% of participants 
reported any systemic reaction at any dose, of which 4 participants reported Grade ≥3
solicited systemic reactions. A total of 12 participants (33%) experienced in total 20 TEAEs 
of which 4 events were related TEAEs. Grad e ≥3 TEAEs were experienced by 3
participants (2%) (orthostatic in tolerance) which was assessed a s not related Grade ≥3
TEAE by the investigator. One participant in the older participa nts group had a serious not 
related TEAE (ankle fracture).
The frequency of local and systemic reactogenicity was generall y lower for BNT162b2 
compared to BNT162b1. BNT162b2 generally had a milder and there fore more favorable 
reactogenicity profile than BNT162b1 across dose levels.
Additionally, the frequency of local and systemic reactogenicity as well as TEAEs was 
lower in the older participants group compared to the younger p articipants group as shown 
inTable 41 .
Generally, good tolerability was observed for both IMPs. Overal l, many of the reported AEs 
appear to represent reactogenicity events anticipated for IM-ad ministered vaccines, 
typically with an onset within fi rst 24 h post dosing. All TEAE s / reactogenicity symptoms 
resolved spontaneously, mostly within 24 h of onset, and were m anaged with simple 
measures and widely available me dications such as analgesics an d anti-pyretics (e.g., 
paracetamol). The observed reactogenicity was mild or moderate in severity. 
Reactogenicity was generally higher after the second dose, but symptoms resolved quickly 
over the course of a few days. There were no deaths, or TEAEs o f special interest 
reported in this study. In the o lder participants group, one pa rticipant treated with 20 μg 
BNT162b1 and one participant treated with 20 μg BNT162b2 had a s erious not related 
TEAE.
None of the participants dosed with BNT162b2 experienced any sev ere local reactions 
while 6 participants (10%) dosed  with BNT162b1 experienced seve re systemic reactions. 
BNT162b1 was less well tolerated with every second participant experiencing severe 
systemic and local reactions on at least one occasion for the d ose range 10, 20, 30, 50 
and 60 μg groups. While the local tolerability profiles of BNT16 2b1 and BNT162b2 are, in 
general similar, the overall systemic reactogenicity profiles c learly are more favorable for 
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(Day 29), virus neutralizing GMTs showed a strong, dose level de pendent booster 
response. In the 60 μg dose group, which was only dosed once, vir us neutralizing GMTs 
remained at a lower level, indicating that a booster dose is necessary to increase 
functional antibody titers.
On Day 43 (21 d after Dose 2 of BNT162b1), virus neutralizing GMTs decreased (with 
exception of the 1 μg dose level). Day 43 virus neutralizing GMTs were 0.7-fold (1 μg) to 
3.6-fold (50 μg) those of a COVID-19 HCS panel.Participants dosed with BNT162b2 showed a strong IMP-induced an tibody response. Virus 
neutralizing GMTs were detected at 21 d after Dose 1 (Day 22) and had increased 
substantially by 7 d after Dose 2 (Day 29) in participants aged 18 to 55 yrs (younger 
participants) dosed with ≥3 μg BNT162b2, and par ticipants aged 56 to 85 yrs (older 
participants) dosed with 20 μg BNT162b2. Day 29 virus neutraliz ing GMTs were 
comparable between the two groups when dosed with 20 μg BNT162b2.
On Day 43 (21 d after Dose 2 of BNT162b2), virus neutralizing GMTs in the younger adult 
dose groups decreased for the 3, 20, and 30 μg dose groups. There after, GMTs remained 
stable up to Day 85 (63 d after Dose 2) for younger adult dose gro ups 10, 20, and 30 μg 
BNT162b2 and were 1.3-fold to 1.9 -fold those of a COVID-19 HCS panel.
All participants dosed with Dose 1 at ≥30 μg BNT162b1 or BNT162b2 seroconverted either 
by 7 d or 21 d after Dose 2 (Day 29 or Day 43). All participants dosed with 30 μg 
BNT162b2 remained seropositive t hroughout the follow-up until D ay 85.
The observed kinetics of the BNT162b1- and BNT162b2-induced neut ralizing antibody 
response is typical of antigen-act ivated B cells going through over proliferation, followed by 
rebound contraction with a gradual decline in numbers before stabilization of the immune 
response.
Walsh et al. (2020) reported similar serological responses elicited by BNT162b 1 and 
BNT162b2 in the ongoing clinical s tudy BNT162-02/C4591001 (Clini calTrials.gov 
NCT04368728). For younger participants, the Day 29 virus neutrali zing GMTs ranged from 
2.8 to 3.8 times the GMT in the COVID-19 HCS panel. This is con sistent with the data 
reported in this interim CSR, w here Day 29 virus neutralizing GM Ts for the 30 μg 
BNT162b1 and BNT162b2 dose groups were both 3.3-fold those of a COVID-19 HCS 
panel.Both BNT162b1 and BNT162b2 elicited lower antigen-binding IgG GM Cs and virus 
neutralizing GMTs in participants aged 65 to 85 yrs (elderly participants) compared to in 
participants aged 18 to 55 yrs (younger participants) in study BNT1 62-02/C4591001. The 
reported Day 29 (7 d after Dose 2) virus neutralizing GMTs in the elderly participants 
measured after dosing with 30 μg BNT162b1 or BNT162b2 still exce eded the GMT in the 
COVID-19 HCS panel by 1.1 to 1.6-fold. As observed with other va ccines this might be 
attributable to immunosenescence ( Boraschi et al. 2010 ). However, comparable 
serological differences between the younger and older adults at  Day 29 (n=12; 20 μg dose 
level) are shown in this interim CSR. Virus neutralizing GMTs we re 2.1-fold compared to 
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In summary, the antibody responses elicited by BNT162b1 and BNT162b2 reported in this 
interim CSR largely complement and confirm the data reported by Mulligan et al. (2020) 
andWalsh et al. (2020) for the study BNT162-02/C4591001.
Cell-mediated immune responses
In both younger and older participants, two doses of BNT162b1 a nd BNT162b2 induced 
strong SARS-CoV-2 RBD-specific and S protein-specific T-cell re sponses. RBD- and 
S protein-specific CD4+T-cell responses were induced by BNT162b1 in 97.5% of 
participants and by BNT162b2 in 100% of participants. RBD- and S protein-specific CD8+
T-cell responses were induced by BNT162b1 in 95.5% of participa nts and by BNT162b2 in 
96.6% of participants.
The T-cell responses elicited by BNT162b2 were directed against additional epitopes of 
the S antigen outside RBD, indicating the induction of multi-ep itopic responses by 
BNT162b2 in both age groups. The magnitude of the T-cell respon ses did not show clear 
dose dependency.
Dosing twice with BNT162b1 or BNT162b2, led to a substantial in crease in incidence and 
magnitude of T-cell responses in both age groups, and across all dose levels for 
BNT162b1. While the magnitude of CD4+T-cell responses induced by BNT162b2 was 
also similar across different dose levels, the magnitude of CD8+T-cell responses was 
highest at the 30 μg dose level. The participants with the strong est CD4+T-cell responses 
had more than 10-fold of the memory responses observed in the same participants against 
immunodominant peptides from cytomegalovirus, Epstein-Barr viru s, influenza virus, and 
tetanus toxoid. The same participants also had strong CD8+T-cell responses that were 
comparable to memory responses against the above mentioned vira l antigens.
BNT162b2-induced CD4+and CD8+T-cell responses showed a decrease on Day 85, but 
remained detectable on Day 184 in almost all participants vaccin ated with >10 μg at levels 
higher than or in range of recall antigen memory responses.
De novo induction of SARS-CoV-2 S or RBD protein directed T cells was co nfirmed using 
ICS. IFN J-producing CD4 and CD8 T cells against SARS-CoV-2 S protein or RBD  were 
induced robustly by both BNT162b 1 and BNT162b2. No clear dose d ependency was 
observed for both IMPs. The cytokine responses elicited after dosing with either 
BNT162b1 or BNT162b2 in older participants was mostly identical  in response pattern and
intensity with that in younger participants.
BNT162b1 and BNT162b2 induced poly-functional and pro-inflammato ry CD4+/CD8+T-cell 
responses in almost all participants. The detection of IFN J, IL-2 but not IL-4 indicates a 
favorable Th1 profile and the absence of a potentially deleteri ous Th2 immune response.
BNT162b2 induced poly-functional and pro-inflammatory CD4+/CD8+T-cell responses in 
almost all participants persistin g in the majority of participa nts for up to 6 months after 
Dose 1. The Th1 polarization of the helper T-cell response was c haracterized by a robust 
IFNJ/IL-2 and only minor IL-4 production upon antigen-specific (wild-type SARS-CoV-2
S protein peptide pools) re-stimulation which was still observed , although with a reduced 
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This data complements the data reported by  Mulligan et al. (2020) by providing a detailed 
characterization of antibody and T-cell immune responses elicit ed by dosing with 
BNT162b1.
Overall conclusions
xThe majority of events reported were reactogenicity symptoms co mpared to TEAEs 
which were anticipated for IM-administered vaccines. The observ ed reactogenicity 
was mild or moderate in severity. The results of this study sho w that BNT162b1 and 
BNT162b2 are well tolerated and have an acceptable safety profile in younger 
participants aged 18 to 55 yrs and older participants aged 56 to 85 yrs.
xThe frequency of local and systemic reactogenicity was generall y lower for 
BNT162b2 compared to BNT162b1. BNT162b2 generally had a milder and therefore more favorable reactogenicity profile than BNT162b1 across dose  levels.
xParticipants dosed with BNT162b1 (1 to 50 μg) showed a strong, I MP- and dose-
dependent antibody response in a SARS-CoV-2 neutralization assa y by Day 22 (at
21 d after Dose 1). This response increased further by Day 29 (at 7 d after Dose 2), 
and the second dose elicited a booster effect. By Day 43 (21 d af ter Dose 2), the 
observed responses decreased for most dose levels. For particip ants dosed at 
≥10μg BNT162b1, Day 43 neutralizing GMTs were comparable or even su perior to 
those of a COVID-19 HCS panel.
xIndependent of age, participants dosed with BNT162b2 (1 to 30 μg ) showed strong 
IMP-induced antibody responses. Virus neutralizing GMTs were de tected after
Dose 1 and showed a substantial booster response by 7 d after Dos e 2 (Day 29) for 
dose level groups ≥3 μg. On Day 43, neutralizing GMTs in the younger participant 
dose groups decreased for the 3, 20, and 30 μg dose levels. Thereafter, GMTs remained stable up to Day 85 (63 d after Dose 2) for younger adult  dose groups 10, 
20, and 30 μg BNT162b2 and were comparable or even superior to t hose of a 
COVID-19 HCS panel.
xAfter dosing with ≥30 μg BNT162b1 and BNT162b2, all participants showed GMC-
and GMT-based seroconversion by either 7 d or 21 d after Dose 2 (D ay 29 or 
Day 43). All participants dosed with 30 μg BNT162b2 remained sero positive 
throughout the follow-up until Day 85.
xThe observed kinetics of the BNT162b1 and BNT162b2 induced neut ralizing antibody 
response is typical of antigen-a ctivated B cells going through o ver proliferation, 
followed by rebound contraction with a gradual decline in numbe rs before stabilization 
of the immune response.
xIn both younger and older participants, two doses of BNT162b1 a nd BNT162b2 
induced strong SARS-CoV-2 RBD-specific and S protein-specific T- cell responses. 
RBD- and S protein-specific CD4
+T-cell responses were induced by BNT162b1 in 
97.5% of participants and by BNT162b2 in 100% of participants. RBD- and S protein-
specific CD8+T-cell responses were induced by BNT162b1 in 95.5% of participa nts 
and by BNT162b2 in 96.6% of participants. The magnitude of the T-cell responses 
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xBNT162b2-induced CD4+and CD8+T-cell responses showed a decrease on Day 85, 
but remained detectable on Day 184 in almost all participants va ccinated with >10 μg 
at levels higher than or in range of recall antigen memory resp onses.
xBNT162b1 and BNT162b2 induced poly-functional and pro-inflammat ory CD4+/CD8+
T-cell responses in almost all participants. The detection of I FNJand IL-2, but no or 
only minor IL-4 production, indica tes a favorable Th1 profile. No notable age-related 
differences were observed.
xFor the majority of participants, the strong S-specific IFN J+and IL-2+CD8+and Th1 
CD4+T-cell responses contracted by Day 43 (21 d post-Dose 2) and plate aued at a 
lower level towards Day 85 (63 d post-Dose 2). This observation he ld true for all dose 
groups analyzed with varying response magnitudes between indivi duals. For the 
younger participants, the cell-mediated immune responses remained detectable until 
Day 184 (162 d post-Dose 2).
xThe favorable tolerability profile was the major driver for cho osing BNT162b2 for 
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14 TABLES AND FIGURES
Note to reader
BNT162b1
General considerations
14.1 Disposition and baseline characteristics
Table 14.1-2-1: Analysis sets - BNT162b1
14.1-3 Premature discontinuation
Table 14.1-3.1-1: Premature disco ntinuation by group - BNT162b1
14.1-4 Demographic characteristics
Table 14.1-4.1-1: Demographic charac teristics, continuous - BNT162 b1
Table 14.1-4.2-1: Demographic characteristics, categorical - BNT16 2b1
14.3 Safety
14.3.1 Primary endpoints
14.3.1-1 Local reactions
Table 14.3.1-1.1-1: Summary of sol icited local reactions - BNT162b 1
Table 14.3.1-1.2-1: Summary of solicited local reactions - complet ers only - BNT162b1
Table 14.3.1-1.3-1: Frequency of s ubjects with solicited local re actions by grade - BNT162b1
Table 14.3.1-1.4-1: Frequency of s ubjects with solicited local re actions by grade - completers 
only - BNT162b1
Table 14.3.1-1.5.1-1: Descriptive statistics of time of solicite d local and any solicited reactions -
BNT162b1
Table 14.3.1-1.5.2-1: Descriptive statistics of time of solicit ed local reactions by term - BNT162b1
Table 14.3.1-1.6.1-1: Frequency of subjects with solicited local and any solicite d reactions per 
day - BNT162b1
Table 14.3.1-1.6.2-1: Frequency of subjects with solicited loca l reactions by term per day -
BNT162b1
14.3.1-2 Systemic reactions
Table 14.3.1-2.1-1: Summary of solicited systemic reactions - BNT 162b1
Table 14.3.1-2.2-1: Summary of solicited systemic reactions - com pleters only - BNT162b1
Table 14.3.1-2.3-1: Frequency of subjects with solicited systemi c reactions by grade -
BNT162b1
Table 14.3.1-2.4-1: Frequency of subjects with solicited systemi c reactions by grade -
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Table 14.3.1-2.5.1-1: Descriptive statistics of time of solicit ed systemic reactions - BNT162b1
Table 14.3.1-2.5.2-1: Descriptive statistics of time of solicit ed systemic reactions by term -
BNT162b1
Table 14.3.1-2.6.1-1: Frequency of subjects with solicited syst emic reactions per day -
BNT162b1
Table 14.3.1-2.6.2-1: Frequency of subjects with solicited syst emic reactions by term per day -
BNT162b1
14.3.1-3 Adverse events
Table 14.3.1-3.1.1-1: Summary of TEAEs - BNT162b1
Table 14.3.1-3.1.2-1: Summary of TEAEs - completers only - BNT162b 1
Table 14.3.1-3.1.3-1: Summary of TEAEs without AEs based on soli cited reporting via diaries -
BNT162b1
Table 14.3.1-3.1.4-1: Summary of TEAEs of special interest - BNT1 62b1
Table 14.3.1-3.2.1-1: Frequency of subjects with TEAEs by SOC an d PT - BNT162b1
Table 14.3.1-3.2.2-1: Frequency of subjects with TEAEs related t o IMP by SOC and PT -
BNT162b1
Table 14.3.1-3.2.3-1: Frequency of subjects with TEAEs of grade >=3 by SOC and PT -
BNT162b1
Table 14.3.1-3.2.4-1: Frequency of subjects with TEAEs of grade >=3 and related to IMP by SOC 
and PT - BNT162b1
Table 14.3.1-3.2.5-1: Frequency of subjects with serious TEAEs by SOC and PT - BNT162b1
Table 14.3.1-3.2.6-1: Frequency of subjects with serious TEAEs r elated to IMP by SOC and PT -
BNT162b1
Table 14.3.1-3.2.7-1: Frequency of subjects with TEAEs with unre solved, fatal or unknown 
outcome by SOC and PT - BNT162b1
Table 14.3.1-3.3.1-1: Frequency of subjects with TEAEs by SOC and  PT - completers only -
BNT162b1
Table 14.3.1-3.4.1-1: Frequency of subjects with TEAEs without A Es based on solicited reporting 
via diaries by SOC and PT - BNT162b1
Table 14.3.1-3.5.1-1: Frequency of subjects with TEAEs by worst grade and SOC and PT -
BNT162b1
Listing 14.3.1-3.7.1-1: Listing of serious adverse events - BNT162 b1
14.3.2 Further safety endpoints
14.3.2-1 Compliance
Table 14.3.2-1.1-1: IMP compliance - BNT162b1
Table 14.3.2-1.2-1: Diary compliance local reactions - BNT162b1Table 14.3.2-1.3-1: Diary complia nce systemic reactions - BNT162b 1
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14.3.2-2.1 Descriptive statistics
Table 14.3.2-2.1.1-1: Laboratory: Descriptive statistics, continu ous (Hematology) - BNT162b1
Table 14.3.2-2.1.2-1: Laboratory: Descriptive statistics, contin uous (Chemistry) - BNT162b1
Table 14.3.2-2.1.3-1: Laboratory: Descriptive statistics, contin uous (Urinalysis) - BNT162b1
Table 14.3.2-2.1.4-1: Laboratory: Descriptive statistics, catego rical (Urinalysis) - BNT162b1
14.3.2-2.5 Abnormal and clinically significant values per visit
Table 14.3.2-2.5.1-1: Laboratory: Abnormal and clinically signif icant values per visit (Hematology) 
- BNT162b1
Table 14.3.2-2.5.2-1: Laboratory: Abnormal and clinically signif icant values per visit (Chemistry) -
BNT162b1
Table 14.3.2-2.5.3-1: Laboratory: Abnormal and clinically signif icant values per visit (Urinalysis) -
BNT162b1
14.3.2-3 Vital signs
Table 14.3.2-3.1-1: Vital signs: Descriptive statistics - BNT162b 1
Table 14.3.2-3.3-1: Vital signs: Abnormal and clinically signifi cant values per visit - BNT162b1
BNT162b2
General considerations
14.1 Disposition and baseline characteristics
Table 14.1-2-3: Analysis sets - BNT162b214.1-3 Premature discontinuation
Table 14.1-3.1-3: Premature discontinuation by group - BNT162b2
14.1-4 Demographic characteristics
Table 14.1-4.1-3: Demographic char acteristics, continuous - BNT16 2b2
Table 14.1-4.2-3: Demographic characteristics, categorical - BNT1 62b2
14.3 Safety
14.3.1 Primary endpoints
14.3.1-1 Local reactions
Table 14.3.1-1.1-3: Summary of solicited local reactions - BNT162b2
Table 14.3.1-1.2-3: Summary of solicited local reactions - comple ters only - BNT162b2
Table 14.3.1-1.3-3: Frequency of s ubjects with solicited local re actions by grade - BNT162b2
Table 14.3.1-1.4-3: Frequency of subjects with solicited local r eactions by grade - completers 
only - BNT162b2
Table 14.3.1-1.5.1-3: Descriptive statistics of time of solicit ed local and any solicited reactions -
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Table 14.3.1-1.5.2-3: Descriptive statistics of time of solicit ed local reactions by term - BNT162b2
Table 14.3.1-1.6.1-3: Frequency of subjects with solicited loca l and any solicited reactions per 
day - BNT162b2
Table 14.3.1-1.6.2-3: Frequency of subjects with solicited loca l reactions by term per day -
BNT162b2
14.3.1-2 Systemic reactions
Table 14.3.1-2.1-3: Summary of solicited systemic reactions - BNT 162b2
Table 14.3.1-2.2-3: Summary of solicited systemic reactions - com pleters only - BNT162b2
Table 14.3.1-2.3-3: Frequency of subjects with solicited systemi c reactions by grade -
BNT162b2
Table 14.3.1-2.4-3: Frequency of subjects with solicited systemi c reactions by grade -
completers only - BNT162b2
Table 14.3.1-2.5.1-3: Descriptive statistics of time of solicit ed systemic reactions - BNT162b2
Table 14.3.1-2.5.2-3: Descriptive statistics of time of solicit ed systemic reactions by term -
BNT162b2
Table 14.3.1-2.6.1-3: Frequency of subjects with solicited syst emic reactions per day -
BNT162b2
Table 14.3.1-2.6.2-3: Frequency of subjects with solicited syst emic reactions by term per day -
BNT162b2
14.3.1-3 Adverse events
Table 14.3.1-3.1.1-3: Summary of TEAEs - BNT162b2
Table 14.3.1-3.1.2-3: Summary of TEAEs - completers only - BNT162b 2
Table 14.3.1-3.1.3-3: Summary of TEAEs without AEs based on soli cited reporting via diaries -
BNT162b2
Table 14.3.1-3.1.4-3: Summary of TEAEs of special interest - BNT1 62b2
Table 14.3.1-3.2.1-3: Frequency of subjects with TEAEs by SOC an d PT - BNT162b2
Table 14.3.1-3.2.2-3: Frequency of subjects with TEAEs related t o IMP by SOC and PT -
BNT162b2
Table 14.3.1-3.2.3-3: Frequency of subjects with TEAEs of grade >=3 by SOC and PT -
BNT162b2
Table 14.3.1-3.2.4-3: Frequency of subjects with TEAEs of grade >=3 and related to IMP by SOC 
and PT - BNT162b2
Table 14.3.1-3.2.5-3: Frequency of subjects with serious TEAEs by SOC and PT - BNT162b2
Table 14.3.1-3.2.6-3: Frequency of subjects with serious TEAEs r elated to IMP by SOC and PT -
BNT162b2
Table 14.3.1-3.2.7-3: Frequency of subjects with TEAEs with unre solved, fatal or unknown 
outcome by SOC and PT - BNT162b2
Table 14.3.1-3.3.1-3: Frequency of subjects with TEAEs by SOC an d PT - completers only -
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Table 14.3.1-3.4.1-3: Frequency of subjects with TEAEs without A Es based on solicited reporting 
via diaries by SOC and PT - BNT162b2
Table 14.3.1-3.5.1-3: Frequency of subjects with TEAEs by worst grade and SOC and PT -
BNT162b2
Listing 14.3.1-3.7.1-3: Listing of serious adverse events - BNT162 b2
14.3.2 Further safety endpoints
14.3.2-1 Compliance
Table 14.3.2-1.1-3: IMP compliance - BNT162b2Table 14.3.2-1.2-3: Diary compliance local reactions - BNT162b2
Table 14.3.2-1.3-3: Diary complia nce systemic reactions - BNT162b 2
14.3.2-2 Laboratory
14.3.2-2.1 Descriptive statistics
Table 14.3.2-2.1.1-3: Laboratory: Descriptive statistics, contin uous (Hematology) - BNT162b2
Table 14.3.2-2.1.2-3: Laboratory: Descriptive statistics, contin uous (Chemistry) - BNT162b2
Table 14.3.2-2.1.3-3: Laboratory: Descriptive statistics, contin uous (Urinalysis) - BNT162b2
Table 14.3.2-2.1.4-3: Laboratory: Descriptive statistics, catego rical (Urinalysis) - BNT162b2
14.3.2-2.5 Abnormal and clinically significant values per visitTable 14.3.2-2.5.1-3: Laboratory: Abnormal and clinically signif icant values per visit (Hematology) 
- BNT162b2
Table 14.3.2-2.5.2-3: Laboratory: Abnormal and clinically signif icant values per visit (Chemistry) -
BNT162b2
Table 14.3.2-2.5.3-3: Laboratory: Abnormal and clinically signif icant values per visit (Urinalysis) -
BNT162b2
14.3.2-3 Vital signs
Table 14.3.2-3.1-3: Vital signs: Descriptive statistics - BNT162b 2
Table 14.3.2-3.3-3: Vital signs: Abnormal and clinically significant values per visit - BNT162b2090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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15 REFERENCES
Boraschi D, Del Giudice G, Dutel C, et al. Ageing and immunity:  addressing immune 
senescence to ensure healthy ageing. Vaccine 2010; 28(21): 3627 -31.
Destexhe E, Prinsen MK, van Schöll I, et al. Evaluation of C-re active protein as an 
inflammatory biomarker in rabbits  for vaccine nonclinical safet y studies. J Pharmacol 
Toxico. Methods 2013; 68: 367-73.
Doener F, Hong HS, Meyer I, et al . RNA-based adjuvant CV8102 en hances the 
immunogenicity of a licensed rabies vaccine in a first-in-human trial. Vaccine 2019; 37:
1819-26.
Kamphuis E, Junt T, Waibler Z, et al. Type I interferons direct ly regulate lymphocyte 
recirculation and cause transient blood lymphopenia. Blood 2006 ; 108: 3253-61.
Mulligan M, Lyke KE, Kitchinet N, et al. Phase I/II study of CO VID-19 RNA vaccine 
BNT162b1 in adults. Nature 2020; 586(7830): 589-93.Taylor DN, Treanor JJ, Sheldon EA, et al. Development of VAX128 , a recombinant 
hemagglutinin (HA) influenza-flagellin fusion vaccine with impr oved safety and immune 
response. Vaccine 2012; 30: 5761-9.Tsai MY, Hanson NQ, Straka RJ, et al. Effect of influenza vacci ne on markers of 
inflammation and lipid profile. J Lab Clin Med. 2005; 145: 323-7.US FDA Guidance for Industry - Toxicity Grading Scale for Healthy  Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials.Walsh EE, Frenck R, Falsey AR, et al. Safety and Immunogenicity  of Two RNA-Based 
Covid-19 Vaccine Candidates. N Engl J Med. 2020; 383(25): 2439-50.090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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16 APPENDICES
16.1 Study information
16.1.1 Protocol and protocol amendments16.1.1.1 Protocol incl. amendments 01 to 06
Clinical study protocol incl. amendments 01 to 06
16.1.1.2 Informed consent forms
Participant information leaflet and declaration of consent
Participant information leaflet and declaration of consent –Additional blood sampling: 
Immunomonitoring
Participant information leaflet and declaration of consent –Additional blood sampling: 
Pharmacogenomic testing HLA
16.1.1.3 Protocol amendment history incl. amendments 01 to 06
Clinical study protocol amendment history including amendments 01 to 06
16.1.1.4 Manuals
Pharmacy manual
Appendix to the pharmacy manual
Laboratory manual
Biomarker manual
16.1.2 Sample case report form
Sample case report form
16.1.3 List of IECs
16.1.4 List of investigators and description of investigators an d other important 
participants contributing to the study
16.1.4.1 List of investigators16.1.4.2 Brief curriculum vita for all investigators and other i mportant participants
Curriculum vitae Baumann
Curriculum vitae Berse
Curriculum vitae Casjens
Curriculum vitae Schultz
Curriculum vitae Seitz
16.1.4.3 List of providers
16.1.5 Signatures of coordinating investigator and sponsor signa tories
Coordinating investigator ’s signature
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16.1.6 Listing of participants rece iving test drugs/investigation al products from specific
batches
BNT162-01 batch-b1
BNT162-01 batch-b2
16.1.7 Randomization scheme and codes (participant identificatio n and treatment 
assigned) –(Not applicable)
16.1.8 Audit certificates (Not available)
16.1.9 Documentation of statistical methods
Statistical analysis plan
16.1.10 Documentation of inter-laboratory standardization method s and quality 
assurance procedures (Not applicable)
16.1.11 Publications based on the study (Not applicable)16.1.12 Important publications referenced in the report
Mulligan M et al. 2020  
Walsh E et al. 2020
16.1.13 List of sponsor personnel who materially affected the st udy conduct
16.1.14 R&D Study reports
R-20-0253 - Neutralizing antibody titer and SARS-COV-2 S1- and RBD- specific 
antibody concentration in serum from participants in the BNT162 -01 trial
GA-RB-022-01A - T cell immune monit oring (TCIM) of study participants in the 
BNT162-01 clinical trial - GC(L)P analytical study interim report
R-20-0235 - Analysis of the Th1/2 cytokine profile of BNT162b1-sp ecific CD4 and CD8 
T cells (interim report for 95 subjects)
R-20-0241 - Analysis of the Th1/2 cytokine profile of BNT162b2-sp ecific CD4 and CD8 
T cells (interim report for 74 subjects)
R-20-0244 - Ex vivo ELISpot data processing and analysis within BNT162-01 clinical 
trial
16.2 Participant data listingsNote to readerGeneral considerations BNT162b1General considerations BNT162b216.2.1 Disposition and baseline characteristics
Listing 16.2.1-1-1: Listing o f subject disposition - BNT162b1
Listing 16.2.1-1-3: Listing o f subject disposition - BNT162b2
Listing 16.2.1-2-1: Listing of protocol deviations - BNT162b1
Listing 16.2.1-2-3: Listing of protocol deviations - BNT162b2
Listing 16.2.1-3-1: Listing of s ubjects with premature disconti nuation - BNT162b1
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16.2.1-4 Subjects excluded from analysis sets
Listing 16.2.1-4.1-1: Listing of subjects´ inclusion in analysi s sets - BNT162b1
Listing 16.2.1-4.1-3: Listing of subjects´ inclusion in analysi s sets - BNT162b2
Listing 16.2.1-4.2-1: Listing of subjects excluded from Safety Boost Set - BNT162b1
Listing 16.2.1-4.2-3: Listing of subjects excluded from Safety Boost Set - BNT162b2
Listing 16.2.1-4.3-1: Listing of subjects excluded from Immunog enicity Set - BNT162b1
Listing 16.2.1-4.3-3: Listing of subjects excluded from Immunog enicity Set - BNT162b2
Listing 16.2.1-5-1: Listing of subject demographics - BNT162b1
Listing 16.2.1-5-3: Listing of subject demographics - BNT162b2
16.2.1-6 Prior and concomitant medication
Listing 16.2.1-6.1-1: Listing of prior medication - BNT162b1
Listing 16.2.1-6.1-3: Listing of prior medication - BNT162b2
Listing 16.2.1-6.2-1: Listing of concomitant medication - BNT162 b1
Listing 16.2.1-6.2-3: Listing of concomitant medication - BNT162 b2
Listing 16.2.1-7-1: Listing of medical history - BNT162b1Listing 16.2.1-7-3: Listing of medical history - BNT162b2
16.2.3 Safety
16.2.3-1 Primary endpoints
Listing 16.2.3-1.1-1: Listing of solicited local reactions - BNT 162b1
Listing 16.2.3-1.1-3: Listing of solicited local reactions - BNT 162b2
Listing 16.2.3-1.2-1: Listing of diary compliance local reactio ns - BNT162b1
Listing 16.2.3-1.2-3: Listing of diary compliance local reactio ns - BNT162b2
Listing 16.2.3-1.3-1: Listing of solicited systemic reactions - BNT162b1
Listing 16.2.3-1.3-3: Listing of solicited systemic reactions - BNT162b2
Listing 16.2.3-1.4-1: Listing of diary compliance systemic reac tions - BNT162b1
Listing 16.2.3-1.4-3: Listing of diary compliance systemic reac tions - BNT162b2
Listing 16.2.3-1.5-1: Listing of adverse events - BNT162b1
Listing 16.2.3-1.5-3: Listing of adverse events - BNT162b2
Listing 16.2.3-1.6-1: Listing of adverse events without adverse  events based on 
solicited reporting via diaries - BNT162b1
Listing 16.2.3-1.6-3: Listing of adverse events without adverse events based on 
solicited reporting via diaries - BNT162b2
16.2.3-2 Further safety endpoints
Listing 16.2.3-2.1-1: Listing of drug exposure - BNT162b1
Listing 16.2.3-2.1-3: Listing of drug exposure - BNT162b2
Listing 16.2.3-2.2-1: Listing of laboratory measurements - BNT16 2b1
Listing 16.2.3-2.2-3: Listing of laboratory measurements - BNT16 2b2
Listing 16.2.3-2.3-1: Listing of vital signs - BNT162b1Listing 16.2.3-2.3-3: Listing of vital signs - BNT162b2
Listing 16.2.3-2.9-1: Listing o f SARS-CoV-2 testing - BNT162b1090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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Listing 16.2.3-2.9-3: Listing of SARS-CoV-2 testing - BNT162b2
Listing 16.2.3-2.10-1: Listing of comments - BNT162b1
Listing 16.2.3-2.10-3: Listing of comments - BNT162b2
16.3 Case report forms
16.3.1 CRFs of deaths, other SAEs and withdrawals for AEs (Available on request)16.3.2 Other CRFs submitted (Not applicable)16.4 Individual participant data listings (Not applicable)090177e196970c4c\A pproved\A pproved On: 23-Mar-2021 06:32 (GMT ) 
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s GmbH  
Confidential  Interim Clinica l
 Study Report 
BNT162-01 Page 1 of 1 
Version: 2.0 
Date: 27 NOV  2020  
 
Particip ant data listings - Notes for the reader  
To harmonize d
ata reporting across the different BNT162 clinical studies, the following 
terminology was ha
rmonized in this interim clinical study report (CS
R). The protocol, 
Statistical Analysis Pla n
 (SAP), and the CSR Section 14  tables/figures, and the Section 16  
listings use the ori g
inal BioNTech terminology:  
 
BioNTech terminology  in 
the protoc ol, SAP  
and the CSR appendices  Harmoni zed terminology u se
d  
in the interim CSR  
Boost (dose)  Dose 2 
Coho rt  Dose group  
Immunization  Dosing 
Immunized  Dosed 
Prime (dose)  Dose 1 
(Trial) Subjec t  Participant  
Trial  Study 
Vaccinated  Dosed 
Vaccination  Dosing 
Vaccine  Investigational medicinal produc t 
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Pharmaceuticals GmbH /  Tables - 6. Snapshot A
ll TLFs Final 1.0  BNT162b1  
BNT162 -01 Created on 20 NO
V2020   
 
 
 
 
 
 
Staburo GmbH. Bas ed
 on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020.  General co ns
iderations  
General  
details:  
 
The prog ra
mming is based on SAP final version 4.0.  
 
The last 
digit of the numbering  of tables
, figures and listings indicates the vaccine: 1 for BNT162b1, 2 for BNT162a1, 3 for BNT162b2, 4 for BNT162c2 (single  dose) and
 5 for 
BNT162c2  (p
rime/boost).  
 
Some tab l
es presenting adverse events are presented twice: once using the safety set and  once us i
ng the safety boost set.  
 
The adv e
rse events based on solicited reporting via subjects diaries are defined in the file BNT162 -01_AEs_b a
sed_on_solicited_reporting_via_subjects_diaries_v2.0 MBx_SSt.  
 
The SDTM da ta
 used was received on 03NOV2020 in t he fold e
r SDTM_Group_BC_cutoff_20201023.  
 
The adv e
rse events intensity was assessed on different scales:  
- the 1 µg, 1 0
 µg, 30 µg, 50 µg and 60 µg young cohorts was assessed on a 3 -point s c
ale (mild, moderate, severe)  
- the 3 µg and
 20 µg young cohorts as well as
 the older cohorts were assessed on a 4 -point sc
ale (mild, moderate, severe, potentially life -threateni
ng). 
 
 
Programmi n
g details:  
 
If a tabl e
 which presents categories has any all zero rows, these rows are suppressed.  
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TABLE OF CONTENTS
Participant data listings - Notes for the reader ...............................................................................................................................................
General considerations ..................................................................................................................................................................................14.1 Disposition and baseline characteristics ................................................................................................................................................
Table 14.1-2-1: Analysis sets - BNT162b1 .................................................................................................................................................14.1-3 Premature discontinuation ...............................................................................................................................................................
Table 14.1-3.1-1: Premature discontinuation by group - BNT162b1 .......................................................................................................
14.1-4 Demographic characteristics ............................................................................................................................................................
Table 14.1-4.1-1: Demographic characteristics, continuous - BNT162b1 ...............................................................................................Table 14.1-4.2-1: Demographic characteristics, categorical - BNT162b1 .............................................................................................
14.3 Safety ...................................................................................................................................................................................................
14.3.1 Primary endpoints ..........................................................................................................................................................................
14.3.1-1 Local reactions .........................................................................................................................................................................
Table 14.3.1-1.1-1: Summary of solicited local reactions - BNT162b1 ...............................................................................................Table 14.3.1-1.2-1: Summary of solicited local reactions - completers only - BNT162b1 ..................................................................Table 14.3.1-1.3-1: Frequency of subjects with solicited local reactions by grade - BNT162b1 ........................................................Table 14.3.1-1.4-1: Frequency of subjects with solicited local reactions by grade - completers only - BNT162b1 ............................Table 14.3.1-1.5.1-1: Descriptive statistics of time of solicited local and any solicited reactions - BNT162b1 ...................................Table 14.3.1-1.5.2-1: Descriptive statistics of time of solicited local reactions by term - BNT162b1 ..................................................Table 14.3.1-1.6.1-1: Frequency of subjects with solicited local and any solicited reactions per day - BNT162b1 ............................Table 14.3.1-1.6.2-1: Frequency of subjects with solicited local reactions by term per day - BNT162b1 ..........................................12679
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14.3.1-2 Systemic reactions ...................................................................................................................................................................
Table 14.3.1-2.1-1: Summary of solicited systemic reactions - BNT162b1 ........................................................................................
Table 14.3.1-2.2-1: Summary of solicited systemic reactions - completers only - BNT162b1 ............................................................Table 14.3.1-2.3-1: Frequency of subjects with solicited systemic reactions by grade - BNT162b1 ..................................................Table 14.3.1-2.4-1: Frequency of subjects with solicited systemic reactions by grade - completers only - BNT162b1 ...................Table 14.3.1-2.5.1-1: Descriptive statistics of time of solicited systemic reactions - BNT162b1 ......................................................Table 14.3.1-2.5.2-1: Descriptive statistics of time of solicited systemic reactions by term - BNT162b1 .........................................Table 14.3.1-2.6.1-1: Frequency of subjects with solicited systemic reactions per day - BNT162b1 ...............................................Table 14.3.1-2.6.2-1: Frequency of subjects with solicited systemic reactions by term per day - BNT162b1 ..................................
14.3.1-3 Adverse events ......................................................................................................................................................................
Table 14.3.1-3.1.1-1: Summary of TEAEs - BNT162b1 ...................................................................................................................Table 14.3.1-3.1.2-1: Summary of TEAEs - completers only - BNT162b1 .......................................................................................Table 14.3.1-3.1.3-1: Summary of TEAEs without AEs based on solicited reporting via diaries - BNT162b1 .................................Table 14.3.1-3.1.4-1: Summary of TEAEs of special interest - BNT162b1 ......................................................................................Table 14.3.1-3.2.1-1: Frequency of subjects with TEAEs by SOC and PT - BNT162b1 ..................................................................Table 14.3.1-3.2.2-1: Frequency of subjects with TEAEs related to IMP by SOC and PT - BNT162b1 ...........................................Table 14.3.1-3.2.3-1: Frequency of subjects wi
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