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Interim Clinical Study Report
Protocol C4591001
CONFIDENTIAL
1.TITLE PAGE
Vaccine Name and
Compound Number:BNT162 RNA -Based COVID -19 Vaccines, Compound
Number: PF -07302048
Report Title: Final Anal ysis Interim Report: A Phase 1/2/3, Placebo-
Controlled, Randomized, Observer -Blind, Dose -Finding
Study to Evaluate the Safety , Tolerability ,
Immunogenicit y, and Efficacy of SARS -COV -2 RNA
Vaccine Candidates Against COVI D-19 in Healthy
Individuals
Protocol Number: Protocol C4591001
Sponsor: BioNTech
Sponsor Agent: Pfizer I nc
Phase of Development: Phase 1/2/3
First Subject First Visit: 29 April 2020
Primary Completion Date: Not applicable
Data Cutoff Date s: 24 August 2020 (Phase 1 safet y and immunogenicity
data through 1 month after Dose 2)
02 September 2020 (Phase 2 safet y data 7 days after
Dose 2 only )
04 November 2020 (Phase 2/3 first interim anal ysis for
efficacy )
14 November 2020 (Phase 2/3 final anal ysis for efficacy ,
safet ydata 1 month after Dose 2 for 37,586 participants
with a median of at least 2 months of follow-up , and
available safety data f or all 43,252 participants)
090177e195afe397\Approved\Approved On: 03-Dec-2020 16:12 (GMT)
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Interim Clinical Study Report
Protocol C4591001
CONFIDENTIAL
Serology Completion
Date (s): 17 September 2020 (Phase 1, Visit 7 [post -Dose 2 blood
draw] assay completed)
12 October 2020 (Phase 2, Visit 3 [ post-Dose 2 blood
draw] assay completed)
Name and Affiliation of
Coordinating/Leading
Investigator:Stephen Thomas, MD
SUNY Upstate Medical University
725 Irving Ave, Ste. 311
Syracuse, NY 13210
The names of the principal investigators, site addresses,
and number of participants enrolled at each site are
provided in the appendix titled L ist and Description of
Investigators and Service Providers, Appendix 16.1.4.
Sponsor’s Signatories: John L . Perez, MD, MBA, MA
Vice President, Vaccines Clinical Research and
Develop ment, Pfizer Inc
Kenneth Koury , PhD
Clinical Biostatistics Head, Vaccines Clinical Research
and Development, Pfizer Inc
Ugur Sahin, MD
Chief Executive Officer, BioNTech
Internal Reports Referenced: Not applicable
Date of Current Version: 03December 2020
Date(s) of Previous
Report(s):Not applicable
GCP STATEMENT
This study was conducted in compliance with Good Clinical Practice (GCP) guidelines and,
where applicable, local country regulations relevant to the use of new therapeutic agents in
the countr y/countries of conduct, including the archiving of essential documents.
090177e195afe397\Approved\Approved On: 03-Dec-2020 16:12 (GMT)
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CONFIDENTIAL2. SYNOPSI S
3. TABLE OF CONTENTS
1. TI TLE PAGE ................................ ................................ ................................ ..................... 1
2. SYNOPSI S................................ ................................ ................................ ......................... 3
3. TABLE OF CONTENTS ................................ ................................ ................................ ... 3
4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ................................ ......
5. ETHI CS................................ ................................ ................................ ..............................
5.1. I ndependent Ethics Committee or I nstitutional Review Board................................ ...
5.2. Ethical Conduct of the Study ................................ ................................ .......................
5.3. Participant Information and Consent................................ ................................ ...........
6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE ........................
7. INTRODUCTION ................................ ................................ ................................ .............
8. STUDY OBJECTIVES AND ENDPOINTS ................................ ................................ .....
8.1. Phase 1 ................................ ................................ ................................ .........................
8.2. Phase 2/3................................ ................................ ................................ ......................
9. INVESTIGAT IONAL PL AN................................ ................................ ............................
9.1. Overall St udy Design and Plan ................................ ................................ ....................
9.1.1. Phase 1 ................................ ................................ ................................ ..................
9.1.2. Phase 2/3 ................................ ................................ ................................ ...............
9.2. Discussion of Study Design, Including Choice of Control Groups .............................
9.3. Participant Selection ................................ ................................ ................................ ....
9.3.1. I nclusion Criteria................................ ................................ ................................ ...
9.3.2. Exclusion Criteria ................................ ................................ ................................ ..
9.3.3. Criteria for Temporaril y Dela ying Vaccine Administration ................................ .
9.3.4. Withdrawal of Participants From the Study................................ ..........................
9.4. I nvestigational Product ................................ ................................ ................................
9.4.1. Vaccines Administered ................................ ................................ .........................
9.4.2. I dentity of Investigational Product(s) ................................ ................................ ....
9.4.3. Manufacturing Process ................................ ................................ ..........................
9.4.4. Method of Assigning Par ticipants to Treatment Groups ................................ .......
9.4.5. Selection of Dose Levels/Regimen ................................ ................................ .......
9.4.5.1. Phase 1 ................................ ................................ ................................ ............
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CONFIDENTIAL9.4.5.2. Phase 2/3................................ ................................ ................................ .........
9.4.6. Blinding................................ ................................ ................................ .................
9.4.7. Prior and Concomitant Vaccines, Me dications, and Procedures ..........................
9.4.8. Vaccine Compliance ................................ ................................ .............................
9.5. Efficacy , Immunogenicity , and Safet y Evaluations ................................ ....................
9.5.1. Efficacy and Immunogenicity Evaluati ons ................................ ...........................
9.5.2. Safet y Evaluations ................................ ................................ ................................ .
9.5.2.1. Clinical Safety Laboratory Evaluations (Phase 1 Participants Onl y).............
9.5.2.2. Electronic Diary ................................ ................................ ..............................
9.5.2.3. Phase 1 Stopping Rules ................................ ................................ ...................
9.5.2.4. Surveillance of Events That Could Represent Vaccine- Associated
Enhanced COVID -19 and Phase 2/3 Stopping Rule ................................ ............
9.5.2.5. Adverse Events and Serious Adverse Events ................................ .................
9.5.2.6. Events of Special I nterest ................................ ................................ ...............
9.6. Data Qualit y Assurance ................................ ................................ ...............................
9.7. Statistical Methods Planned in the Protocol ................................ ................................
9.7.1. Statistical and Analy tical Plans................................ ................................ .............
9.7.1.1. Analy sis Sets ................................ ................................ ................................ ...
9.7.2. Determination of Sample Size ................................ ................................ ..............
9.7.3. Efficacy Anal ysis................................ ................................ ................................ ..
9.7.4. I mmunogenicit y Analysis ................................ ................................ .....................
9.7.5. Safet y Anal ysis................................ ................................ ................................ ......
9.7.6. Other Anal yses................................ ................................ ................................ ......
9.7.7. Analy sis Timing ................................ ................................ ................................ ....
9.8. Changes in the Conduct of Study or Planned Analy ses................................ ..............
10. STUDY PARTI CIPANTS ................................ ................................ ...............................
10.1. Disposition of Participants ................................ ................................ .........................
10.1.1. Phase 1 ................................ ................................ ................................ ................
10.1.2. Phase 2 ................................ ................................ ................................ ................
10.1.2.1. Disposition up to 7 Day s After Dose 2 ................................ .........................
10.1.2.2. Disposition From 7 Day s After Dose 2 to the Data Cutoff Date of 14
November 2020 ................................ ................................ ................................ ....
10.1.3. Phase 2/3 ................................ ................................ ................................ .............
10.1.3.1. Participants with Median 2 Months of Follow -Up After Dose 2 Safety
Population ................................ ................................ ................................ .............
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CONFIDENTIAL10.1.3.2. All Participa nts Safety Population ................................ .............................
10.2. Protocol Deviations ................................ ................................ ................................ ...
10.2.1. Phase 1 ................................ ................................ ................................ ................
10.2.2. Phase 2 ................................ ................................ ................................ ................
10.2.3. Phase 2/3 ................................ ................................ ................................ .............
10.3. Vaccine Administration and Timing ................................ ................................ .........
10.3.1. Phase 1 ................................ ................................ ................................ ................
10.3.2. Phase 2 ................................ ................................ ................................ ................
10.3.3. Phase 2/3 ................................ ................................ ................................ .............
10.4. Data Sets Anal yzed................................ ................................ ................................ ....
10.4.1. Phase 1 ................................ ................................ ................................ ................
10.4.2. Phase 2 ................................ ................................ ................................ ................
10.4.3. Phase 2/3 ................................ ................................ ................................ .............
10.4.3.1. Safet y Populations ................................ ................................ ........................
IN-TEXT TABLES AND FIGURES ................................ ................................ .......
10.4.3.1.1.1. Participants with Median 2 Months of Follow -Up After Dose 2 .....
10.4.3.1.1.2. All Participants................................ ................................ .................
10.4.3.2. Efficacy Populations Interim Anal ysis 1................................ ...................
10.4.3.3. Efficacy Populations Final Analysis ................................ ..........................
10.5. Demographic and Other Baseline Characteristics ................................ .....................
10.5.1. Phase 1 ................................ ................................ ................................ ................
10.5.2. Phase 2 ................................ ................................ ................................ ................
10.5.3. Phase 2/3 ................................ ................................ ................................ .............
10.5.3.1. Participants with Median 2 Months of Follow -Up After Dose 2 Safety
Population Phase 2/3 ................................ ................................ .........................
10.5.3.2. All Participants Safety Population ................................ .............................
10.5.3.3. Evaluable Efficacy Populatio n Without Evidence of Infection up to 7
Days After Dose 2 Interim Analy sis 1................................ ...............................
10.5.3.4. Evaluable Efficacy Population Without Evidence of Infection up to 7
Days After Dose 2 Final Anal ysis................................ ................................ .....
10.6. Participant Compliance ................................ ................................ ..............................
10.6.1. I mmunogenicit y Blood Samples ................................ ................................ .........
10.6.1.1. Phase 1 ................................ ................................ ................................ ..........
10.6.1.2. Phase 2 ................................ ................................ ................................ ..........
10.6.1.3. Phase 2/3................................ ................................ ................................ .......
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CONFIDENTIAL10.6.2. E- Diary ................................ ................................ ................................ ................
10.6.2.1. Phase 1 ................................ ................................ ................................ ..........
10.6.2.2. Phase 2 ................................ ................................ ................................ ..........
10.6.2.3. Phase 2/3................................ ................................ ................................ .......
10.7. Prior and Concomitant Vaccines, Medications, and Procedures ...............................
10.7.1. Phase 1 ................................ ................................ ................................ ................
10.7.2. Phase 2 ................................ ................................ ................................ ................
10.7.3. Phase 2/3 ................................ ................................ ................................ .............
10.7.3.1. Participants with Median 2 Months of Follow -Up After Dose 2 Safety
Population Phase 2/3 ................................ ................................ .........................
10.7.3.2. All Par ticipants Safety Population ................................ .............................
11. EFFI CACY AND IMMUNOGENICITY EVALUATION................................ .............
11.1. Efficacy Results ................................ ................................ ................................ .........
11.1.1. I nterim Anal ysis 1................................ ................................ ...............................
11.1.1.1. First Primary Efficacy Endpoint Interim Analy sis 1 ................................ .
11.1.1.2. COVID -19 Narratives - Interim Anal ysis 1................................ ..................
11.1.1.3. Severe COVID -19 Cases - Interim Analysis 1 ................................ .............
11.1.1.4. Efficacy Conclusions -Interim Anal ysis 1................................ ...................
11.1.2. Final Anal ysis................................ ................................ ................................ ......
11.1.2.1. Signs and Sy mptoms of COVI D-19 ................................ .............................
11.1.2.2. Primary Efficacy Endpoints Final Analy sis................................ ...............
11.1.2.2.1. Vaccine Efficacy Without Prior Evidence of SARS -CoV -2 Infection
7 Day s After Dose 2 Final Anal ysis................................ ...............................
11.1.2.2.2. Vaccine E fficacy With or Without Prior Evidence of SARS -CoV -2
Infection 7 Day s After Dose 2 Final Anal ysis................................ ............
11.1.2.2.3. All Confirmed Cases o f COVID -19 After Dose 1 ................................ .
11.1.2.2.4. Vaccine Efficacy by Subgroup Final Analy sis................................ ....
11.1.2.2.4.1. Subgroups of Age, Sex, Race/Ethnicity , and Country .....................
11.1.2.2.4.2. Subgroups of Risk Status ................................ ................................ .
11.1.2.2.4.2.1. Participants Without Evidence of Infection Before and During
Vaccination Regimen ................................ ................................ .................
11.1.2.3. Secondary Efficacy Endpoints Final Analy sis................................ ...........
11.1.2.3.1. Vaccine Efficacy For COVID -19 Occurring ≥14 Day s After Dose 2
–Final Anal ysis................................ ................................ ...............................
11.1.2.3.1.1. Participants Without Evidence of Infection Before and During
Vaccination Regimen ................................ ................................ .....................
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CONFIDENTIAL11.1.2.3.1.2. Participants With or Without Evidence of Infection Before and
During V accination Regimen ................................ ................................ ........
11.1.2.3.2. Vaccine Efficacy for Severe COVID- 19 Cases Final Analy sis..........
11.1.2.3.2.1. Efficacy Against Severe COVID -19 (≥7 Day s After Dose 2) .......
11.1.2.3.2.1.1. Participants Without Evidence of Infection Before and During
Vaccination Regimen ................................ ................................ .................
11.1.2.3.2.1.2. Participants With or Without Evidence of Infection Before
and During Vaccination Regimen ................................ ..............................
11.1.2.3.2.1.3. All Confirmed Cases of Severe COVID-19 A fter Dose 1
All-Available Population................................ ................................ ............
11.1.2.3.2.2. Efficacy Against Severe COVID -19 (≥14 Day s After Dose 2) .....
11.1.2.3.2.2.1. Participants Without Evidence of Infection Before and During
Vaccination Regimen (14 Day s) Severe ................................ ..................
11.1.2.3.2.2.2. Participants With or Without Evidence of Infection Before
and During Vaccination Regimen (14 Day s) Severe ...............................
11.1.2.3.3. Vaccine Efficacy for COVID- 19 Cases per CDC Definition Final
Analy sis................................ ................................ ................................ .............
11.1.2.3.3.1. Efficacy Against COVID -19 Based on CDC -Defined S ymptoms
(≥7 Day s After Dose 2) ................................ ................................ ................
11.1.2.3.3.1.1. Participants Without Evide nce of Infection Before and During
Vaccination Regimen CDC Defined 7 Day s ................................ ........
11.1.2.3.3.1.2. Participants With or Without Evidence of Infection Before
and During Vaccination Regimen CDC Defined 7 Day s.....................
11.1.2.3.3.2. Efficacy Against COVID -19 Based on CDC -Defined S ymptoms
(≥14 Day s After Dose 2) ................................ ................................ ..............
11.1.2.4. Efficacy Conclusions Final Anal ysis................................ .........................
11.2. I mmunogenicit y Results ................................ ................................ ............................
11.2.1. Phase 1 ................................ ................................ ................................ ................
11.2.1.1. SARS -CoV -2 Neutralizing Titers Phase 1 ................................ .................
11.2.1.1.1. GMTs ................................ ................................ ................................ ......
11.2.1.1.2. GMFRs ................................ ................................ ................................ ...
11.2.1.1.3. Number (%) of Participants Achieving a ≥4-Fold Rise ........................
11.2.1.2. SARS -CoV -2 Antigen -Specific Binding Antibody Levels Phase 1 ..........
11.2.1.2.1. GMCs ................................ ................................ ................................ .....
11.2.1.2.2. GMFRs ................................ ................................ ................................ ...
11.2.1.2.3. Number (%) of Participants Achieving a ≥4-Fold Rise ........................
11.2.1.3. GMRs of SARS -CoV -2-Neutralizing Titers to SARS -CoV -2 Antigen -
Specific Binding Antibody Levels ................................ ................................ .......
11.2.2. Phase 1 Summary of I mmunogenicity Results Evaluating BNT162b1 and
BNT162b2 ................................ ................................ ................................ ................
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CONFIDENTIAL11.2.3. Phase 1 I mmunogenicity Conclusions ................................ ................................
11.2.4. Phase 2 ................................ ................................ ................................ ................
11.2.4.1. SARS -CoV -2 Neutralizing Titers and S1- Binding IgG Concentrations
Phase 2 ................................ ................................ ................................ ..................
11.2.4.1.1. GMTs/GMCs ................................ ................................ ..........................
11.2.4.1.2. GMFR s in Titers/Concentrations ................................ ...........................
11.2.4.2. SARS -CoV -2 Neutralizing Titers and S1- Binding IgG Concentrations by
Baseline SARS -CoV -2 Status ................................ ................................ ..............
11.2.4.2.1. GMTs/GMCs ................................ ................................ ..........................
11.2.4.2.2. GMFRs in Titers/Concentrations ................................ ...........................
11.2.5. Phase 2 I mmunogenicity Conclusions ................................ ................................
11.2.6. Phase 3 ................................ ................................ ................................ ................
12. SAFETY EVALUATION ................................ ................................ ...............................
12.1. Phase 1 ................................ ................................ ................................ .......................
12.1.1. L ocal Reacti ons Phase 1 ................................ ................................ ...................
12.1.2. Sy stemic Events Phase 1 ................................ ................................ ..................
12.1.3. Adverse Events Phase 1 ................................ ................................ ...................
12.1.3.1. Summary of Adverse Events Phase 1 ................................ ........................
12.1.3.1.1. Up to 1 Month After Dose 2................................ ................................ ...
12.1.3.1.2. Through the Data Cutoff Date (BNT162b2 30- µg)................................
12.1.3.2. Analy sis of Adverse Events Phase 1 ................................ ..........................
12.1.3.2.1. Adverse Events by System Organ Class and Preferred Term Phase 1
12.1.3.2.1.1. Up to 1 Month After Dose 2/3 Weeks After Dose 1 (BNT162b2
100 µg Group) ................................ ................................ ................................
12.1.3.2.1.2 . Through the Data Cutoff Date (BNT162b2 30- µg).........................
12.1.3.2.2. Related Adverse Events Phase 1 ................................ .........................
12.1.3.2.2.1. Up to 1 Month After Dose 2/3 Weeks After Dose 1 (BNT162b2
100 µg Group) ................................ ................................ ................................
12.1.3.2.2.2. Through the Data Cutoff Date (BNT162b2 30 -µg).........................
12.1.3.2.3. I mmediate Adverse Events Phase 1 ................................ ....................
12.1.3.2.4. Severe Adverse Events Phase 1 ................................ ...........................
12.1.3.2.4.1. Up to 1 Month After Dose 2/3 Weeks After Dose 1 (BNT162b2
100 µg Group) ................................ ................................ ................................
12.1.3.2.4.2. Thr ough the Data Cutoff Date (BNT162b2 30 -µg).........................
12.1.4. Deaths, Serious Adverse Events, Safet y-Related Participant Withdrawals, and
Other Si gnificant Adverse Events Phase 1 ................................ ...........................
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CONFIDENTIAL12.1.4.1. Deaths Phase 1 ................................ ................................ ...........................
12.1.4.2. Serious Adverse Events Phase 1 ................................ ................................
12.1.4.3. Safet y-Related Participant Withdra wals Phase 1 ................................ .......
12.1.4.4. Other Significant Adverse Events Phase 1 ................................ ................
12.1.4.5. Other Safet y Assessments Phase 1 ................................ ............................
12.1.4.5.1. Severe COVID -19 Illness Phase 1 ................................ ......................
12.1.4.5.2. Pregnancy Phase 1 ................................ ................................ ...............
12.1.4.6. Analy sis and Discussion of Deaths, Serious Adverse Events, Safety -
Related Participant Withdrawals, and Other Significant Adverse Events
Phase 1 ................................ ................................ ................................ ..................
12.1.5. Clinical L aboratory Evaluation Phase 1 ................................ ...........................
12.1.6. Phy sical Examination Findings Phase 1 ................................ ..........................
12.1.7. Phase 1 Summary of Safet y Results Evaluating BNT162b1 and BNT162b2 ....
12.1.8. Phase 1 Safet y Conclusions ................................ ................................ ................
12.2. Phase 2 ................................ ................................ ................................ .......................
12.2.1. L ocal Reactions Phase 2 ................................ ................................ ...................
12.2.2. Sy stemic Events Phase 2 ................................ ................................ ..................
12.2.3. Adverse Events Phase 2 ................................ ................................ ...................
12.2.3.1. Summary of Adverse Events Phase 2 ................................ ........................
12.2.3.1.1. Up to 7 Days After Dose 2 - Phase 2 ................................ ......................
12.2.3.1.2. Through the Data Cutoff Date - Phase 2 ................................ ................
12.2.3.2. Analy sis of Adverse Events Phase 2 ................................ ..........................
12.2.3.2.1. Adverse Events by System Organ Class and Preferred Term Phase 2
12.2.3.2.1.1. Up to 7 Days After Dose 2 Phase 2 ................................ ..............
12.2.3.2.1.2. Through the Data Cutoff Date Phase 2 ................................ .........
12.2.3.2.2. Related Adverse Events b y System Organ Class and Preferred Term
Phase 2 ................................ ................................ ................................ ...............
12.2.3.2.3. I mmediate Adverse Events Phase 2 ................................ ....................
12.2.3.2.4. Severe or Life-Threatening Adverse Events Phase 2 ..........................
12.2.4. Deaths, Serious Adverse Events, Safet y-Related Participant Withdrawals, and
Other Significant Adverse Events Phase 2 ................................ ...........................
12.2.4.1. Deaths Phase 2 ................................ ................................ ...........................
12.2.4.2. Serious Adverse Events Phase 2 ................................ ................................
12.2.4.3. Safet y-Related Participant Withdrawals Phase 2 ................................ .......
12.2.4.3.1. Narratives of Safety -Related Participant Withdrawals Phase 2 ..........
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CONFIDENTIAL12.2.4.4. Other Significant Adverse Event s Phase 2 ................................ ................
12.2.4.5. Analy sis and Discussion of Deaths, Serious Adverse Events, Safety -
Related Participant Withdrawals, and Other Sign ificant Adverse Events
Phase 2 ................................ ................................ ................................ ..................
12.2.5. Phase 2 Safet y Conclusions ................................ ................................ ................
12.3. Phase 2/3................................ ................................ ................................ ....................
12.3.1. L ocal Reactions Phase 2/3 ................................ ................................ ...............
12.3.2. Sy stemic Events Phase 2/3 ................................ ................................ ...............
12.3.3. Adverse Events Phase 2/3 ................................ ................................ ................
12.3.3.1. Summary of Adverse Events Phase 2/3 ................................ .....................
12.3.3.1.1. Participants with Median 2 Months of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ...........
12.3.3.1.1.1. Participants with At L east 2 Months of Follow -Up After Dose 2 ...
12.3.3.1.2. All Participants Phase 2/3 ................................ ................................ ....
12.3.3.2. Analy sis of Adverse Events Phase 2/3 ................................ ......................
12.3.3.2.1. Adverse Events by System Organ Class and Preferred Term Phase
2/3................................ ................................ ................................ ......................
12.3.3.2.1.1. Participants with Median 2 Months of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ........
12.3.3.2.1.1.1. Participants with At L east 2 Months of Follow -Up After Dose
2 ................................ ................................ ................................ ..................
12.3.3.2.1.2. All Participants Phase 2/3 ................................ .............................
12.3.3.2.2. Related Adverse Events b y System Organ Class and Preferred Term
Phase 2/3 ................................ ................................ ................................ ...........
12.3.3.2.2.1. Pa rticipants with Median 2 Months of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ........
12.3.3.2.2.2. Participants with At L east 2 Months of Follow -Up Af ter Dose 2 ...
12.3.3.2.2.3. All Participants Phase 2/3 ................................ .............................
12.3.3.2.3. I mmediate Adverse Events Phase 2/3 ................................ .................
12.3.3.2.3.1. Participants with Median 2 Month s of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ........
12.3.3.2.3.2. All Participants Phase 2/3 ................................ .............................
12.3.3.2.4. Severe or Life-Threatening Adverse Events Phase 2/3 .......................
12.3.3.2.4.1. Participants with Median 2 Months of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ........
12.3.3.2.4.2. All Participants Phase 2/3 ................................ .............................
12.3.4. Deaths, Serious Adverse Events, Safet y-Related Participant Withdrawals, and
Other Significant Adverse Events Phase 2/3 ................................ ........................
12.3.4.1. Deaths Phase 2/3 ................................ ................................ ........................
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CONFIDENTIAL12.3.4.1.1. Death Narratives ................................ ................................ .....................
12.3.4.2. Serious Adverse Events Phase 2/3 ................................ .............................
12.3.4.2.1. Participants with Median 2 Months of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ...........
12.3.4.2.2. All Participants Phase 2/3 ................................ ................................ ....
12.3.4.2.3. Serious Adverse Event Narratives Phase 2/3 ................................ ......
12.3.4.3. Safet y-Related Participant Withdrawals Phase 2/3 ................................ ...
12.3.4.3.1. Participants with Median 2 Months of Follow -Up After Dose 2
Phase 2/3 ................................ ................................ ................................ ...........
12.3.4.3.2. All Participants Phase 2/3 ................................ ................................ ....
12.3.4.3.3. Narratives of Safety -Related Participant Withdrawals Phase 2/3 .......
12.3.4.4. Other Significant Adverse Events Phase 2/3 ................................ .............
12.3. 4.5. Other Safet y Assessments Phase 2/3 ................................ .........................
12.3.4.5.1. Severe COVID -19 Illness Phase 2/3 ................................ ...................
12.3.4.5.2. Pregnancy Phase 2/3 ................................ ................................ ............
12.3.4.6. Analy sis and Di scussion of Deaths, Serious Adverse Events, Safety-
Related Participant Withdrawals, and Other Significant Adverse Events
Phase 2/3 ................................ ................................ ................................ ...............
12.3.5. Phase 2/3 Safet y Conclusions ................................ ................................ .............
13. DI SCUSSION AND OVERALL CONCLUSIONS ................................ ........................
13.1. Discussion................................ ................................ ................................ ..................
13.1.1. Phase 1 ................................ ................................ ................................ ................
13.1.2. Phase 2/3 ................................ ................................ ................................ .............
13.2. Overall Conclusions ................................ ................................ ................................ ..
LIST OF TABLES
Table 1. Phase 1 Objectives, Estimands, and Endpoints................................ ......................
Table 2. Phase 2/3 Objectives, Estimands, and Endpoints ................................ ...................
Table 3. Investigational Produc t Lot Numbers Final Analy sis Interim .............................
Table 4. Anal ysis Populations ................................ ................................ ..............................
Table 5. Disposition of All Randomized Subjects Phase 2 ................................ ...............
Table 6. Disposition o f All Randomized Subjects ~38000 Subjects for Phase 2/3
Analy sis................................ ................................ ................................ .........................
Table 7. Vaccine as Administered by Vaccine Group ~38000 Subjects for Phase 2/3
Analy sis All Randomized Subjects ................................ ................................ ............
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CONFIDENTIALTable 8. Vaccine Administration Timing ~38000 Subjects for Phase 2/3 Analy sis
All Randomized Subjects ................................ ................................ ..............................
Table 9. Safet y Population Phase 2 ................................ ................................ ...................
Table 10. Follow -Up Time After Dose 2 ~38000 Subjects for Phase 2/3 Analy sis
Safety Population ................................ ................................ ................................ ..........
Table 11. Safet y Population ~38000 Subjects for Phase 2/3 Anal ysis..............................
Table 12. Efficacy Populations Interim Anal ysis 1................................ ...........................
Table 13. Efficacy Populations ................................ ................................ .............................
Table 14. Subjects Excluded From Evaluable Efficacy Population Due to Important
Protocol Deviations on or Prior to 7 Day s After Dose 2 ................................ ...............
Table 15. Demographic Characteristics Phase 2 Safety Population ...............................
Table 16. Demographic Characteristics ~38000 Subjects f or Phase 2/3 Analy sis
Safety Population ................................ ................................ ................................ ..........
Table 17. Demographic Characteristics Subjects Without Evidence of I nfection Prior
to 7 Day s After Dose 2 Evaluable Efficacy Population (7 Day s) Interim
Analy sis 1 ................................ ................................ ................................ ......................
Table 18. Demographic Characteristics Subjects Without E vidence of I nfection Prior
to 7 Day s After Dose 2 Evaluable Efficacy (7 Day s) Population ..............................
Table 19. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2
Subjects Without Evidence of Infection Prior to 7 Day s After Dose 2 Evaluable
Efficacy Population (7 Day s) Interim Analy sis 1 ................................ ......................
Table 20. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2,
by Subgroup Subjects Without Evidence of I nfection Prior to 7 Day s After Dose
2 Evaluable Efficacy Population (7 Day s) Interim Analy sis 1 ...............................
Table 21. Severe COVID -19 Occurrence After Dose 1 Dose 1 All -Available Efficacy
Population Interim Analy sis 1 ................................ ................................ ....................
Table 22. Summary of Signs and S ymptoms for COVID -19 Occurrence From 7 Day s
After Dose 2 Subjects Without Evidence of I nfection Prior to 7 Day s After Dose
2 Evaluable Efficacy (7 Day s) Population ................................ ................................ .
Table 23. Summary of Signs and S ymptoms for COVID -19 Occurrence From 7 Day s
After Dose 2 Subjects With or Without Evidence of Infection Prior to 7 Day s
After Dose 2 Evaluable Efficacy (7 Day s) Population ................................ ...............
Table 24. Summar y of Signs and S ymptoms for COVID -19 Occurrence After Dose 1
Dose 1 All -Available Efficacy Population ................................ ................................ ....
Table 25. Summary of Signs and Sy mptoms for Severe COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infection Prior to 7 Days After
Dose 2 Evaluable Efficacy (7 Day s) Population ................................ ........................
Table 26. Summary of Signs and S ymptoms for Severe COVID -19 Occurrence After
Dose 1 Dose 1 All -Available Efficacy Population ................................ .....................
Table 27. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2
Subjects Without Evidence of Infection Prior to 7 Day s After Dose 2 Evaluable
Efficacy (7 Day s) Population ................................ ................................ ........................
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CONFIDENTIALTable 28. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2
Subjects Without Evidence of Infection Prior to 7 Day s After Dose 2 Dose 2 All -
Avai lable Efficacy Population ................................ ................................ .......................
Table 29. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2
Subjects With or Without Ev idence of Infection Prior to 7 Day s After Dose 2
Evaluable Efficacy (7 Day s) Population ................................ ................................ .......
Table 30. Vaccine Efficacy First COVID -19 O ccurrence From 7 Day s After Dose 2
Subjects With or Without Evidence of Infection Prior to 7 Day s After Dose 2
Dose 2 All -Available Efficacy Population ................................ ................................ ....
Table 31. Vaccine Efficacy First COVID -19 Occurrence After Dose 1 Dose 1 All -
Available Efficacy Population ................................ ................................ .......................
Table 32. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2,
by Subgroup Subjects Without Evidence of I nfection Prior to 7 Day s After Dose
2 Evaluable Efficacy (7 Day s) Population ................................ ................................ .
Table 33. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2,
by Subgroup Subjects With or Without Evidence of Infection Prior to 7 Day s
After Dose 2 Evaluable Efficac y (7 Day s) Population ................................ ...............
Table 34. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2,
by Requested Subgroup Subjects Without Evidence of Infection Prior to 7 Day s
After Dose 2 Evaluable Efficacy (7 Day s) Population ................................ ...............
Table 35. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After Dose 2,
by Risk Status Subjects Without Evidence of I nfection Prior to 7 Day s After
Dose 2 Evaluable Efficacy (7 Day s) Population ................................ ........................
Table 36. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After Dose 2
Subjects Without Evidence of Infection Prior to 14 Day s After Dose 2
Evaluable Efficacy (14 Day s) Population ................................ ................................ .....
Table 37. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After Dose 2
Subjects With or Without Evidence of Infection Prior to 14 Day s After Dose 2
Evaluable Efficacy (14 Day s) Population ................................ ................................ .....
Table 38. Vaccine Efficacy First Severe COVID -19 Occurrence From 7 Day s After
Dose 2 Subjects Without Evidence of Infection Prior to 7 Day s After Dose 2
Evaluable Efficacy (7 Day s) Population ................................ ................................ .......
Table 39. Vaccine Efficacy First Severe COVID -19 Occurrence From 7 Day s After
Dose 2 Subjects With or Without Evidence of Infection Prior to 7 Day s After
Dose 2 Evaluable Efficacy (7 Day s) Population ................................ ........................
Table 40. Vaccine Efficacy First Severe COVID -19 Occurrence After Dose 1 Dose
1 All- Available Efficacy Population ................................ ................................ .............
Table 41. Vaccine Efficacy First Severe COVID -19 Occurrence From 14 Day s After
Dose 2 Subjects Without Evidence of Infection Prior to 14 Day s After Dose 2
Evaluable Efficacy (14 Day s) Population ................................ ................................ .....
Table 42. Vaccine Efficacy First Severe COVID -19 Occurrence From 14 Day s After
Dose 2 Subjects With or Without Evidence of Infection Prior to 14 Day s After
Dose 2 Evaluable Efficacy (14 Day s) Population ................................ ......................
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CONFIDENTIALTable 43. Vaccine Efficacy First COVID -19 Occurrence Based on CDC- Defined
Symptoms From 7 Days After Dose 2 Subjects Without Evidence of I nfection
Prior to 7 Day s After Dose 2 Evaluable Efficacy (7 Day s) Population .....................
Table 44. Vaccine Efficacy First COVID -19 Occurrence Based on CDC- Defined
Symptoms From 7 Day s After Dose 2 Subjects With or Without Evidence of
Infection Prior to 7 Day s After Dose 2 Evaluable Efficacy (7 Day s) Population ......
Table 45. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
7 Day s After Dose 2, b y Age Group Phase 2 Safet y Population Age Group: 18 -
55 Yea rs................................ ................................ ................................ .........................
Table 46. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
7 Day s After Dose 2, b y Age Group Phase 2 Safety Population Age Group: 56 -
85 Years ................................ ................................ ................................ .........................
Table 47. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
7 Day s After D ose 2, b y System Organ Class and Preferred Term Phase 2
Safety Population ................................ ................................ ................................ ..........
Table 48. Number (%) of Subjects Reporting at Least 1 Ser ious Adverse Event From
Dose 1 to 7 Day s After Dose 2, by System Organ Class and Preferred Term
Phase 2 Safet y Population ................................ ................................ ..........................
Table 49. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
1 Month After Dose 2 ~38000 Subjects for Phase 2/3 Anal ysis Safet y
Population ................................ ................................ ................................ ......................
Table 50. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
Data Cutoff Date (14NOV2020) Subjects With 2 Months Follow- Up Time After
Dose 2 for Phase 2/3 Analy sis Safety Population ................................ ......................
Table 51. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
Data Cutoff Date (14NOV2020) Phase 2/3 (All Subjects) Safet y Population ........
Table 52. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose 1 to
1 Month After Dose 2, by S ystem Organ Class and Preferr ed Term ~38000
Subjects for Phase 2/3 Analy sis Safety Population ................................ ....................
Table 53. Number (%) of Subjects Reporting at Least 1 Adverse Even t From Dose 1 to
Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred Term 16-
17 Years of Age Safet y Population ................................ ................................ ............
Table 54. Number (%) of Subjects Reporting at Least 1 Severe Adverse Event From
Dose 1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term 16-17 Years of Age Safet y Population ................................ ..........................
Table 55. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event From
Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred Term
~38000 Subjects for Phase 2/3 Anal ysis Safet y Population ................................ .......
Table 56. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event From
Dose 1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term Phase 2/3 (All Subjects) Safet y Population ................................ ...................
Table 57. Number (%) of Subjects Reportin g at Least 1 Serious Adverse Event From
Dose 1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term 16-17 Years of Age Safet y Population ................................ ..........................
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CONFIDENTIALTable 58. Number (%) of Subjects Withdrawn Because of Adverse Events From Dose 1
to 1 Month After Dose 2, by System Organ Class and Preferred Term ~38000
Subjects for Phase 2/3 Analy sis Safety Population ................................ ....................
LIST OF FIGURES
Figure 1. Stud y Schema ................................ ................................ ................................ ........
Figure 2. Disposition of All Phase 1 Participants................................ ................................ .
Figure 3. Cumulative Incidence Curves for the First COVI D-19 Occurrence Afte r Dose
1 Dose 1 All -Available Efficacy Population ................................ ..............................
Figure 4. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ .........
Figure 5. Geometric Mean Tite rs and 95% CI: SARS -CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ .........
Figure 6. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ .........
Figure 7. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ .........
Figure 8. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 RBD -binding
IgG Level Assay Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age
BNT162b1 Evaluable Immunogenicit y Population ................................ ...................
Figure 9. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 RBD-binding
IgG Level Assay Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age,
BNT162b1 Evaluable Immunogenicit y Population ................................ ...................
Figur e 10. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 S1-binding IgG
Level Assay Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ ......
Figure 11. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 S1-binding IgG
Level Assay Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ ......
Figure 12. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 S1-binding IgG
Level Assay Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ ......
Figure 13. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 S1-binding IgG
Level Assay Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ ......
Figure 14. Geome tric Mean Concentrations and 95% CI : SARS -CoV -2 RBD -binding
IgG Level Assay Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age
BNT162b2 Evaluable Immunogenicit y Population ................................ ...................
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CONFIDENTIALFigure 15. Geometric Mean Concentrations and 95% CI : SARS -CoV -2 RBD -binding
IgG Level Assay Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age
BNT162b2 Evaluable Immunogenicit y Population ................................ ...................
Figure 16. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay
NT50 Phase 2 Dose 2 Evaluable Immunogenicity Population ...............................
Figure 17. Geometric Mean Concentrations and 95% CI : S1-Binding IgG Level Assay
Phase 2 Dose 2 Evaluable I mmunogenicity Population ................................ .............
Figure 18. Subjects Reporting Local Reactions, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 18-55 Year s of Age
BNT162b1 Safet y Population ................................ ................................ ...................
Figure 19. Subjects Reporting Local Reactions, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age
BNT162b1 Safet y Population ................................ ................................ ....................
Figure 20. Subjects Reporting Local Reactio ns, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age
BNT162b2 Safet y Population ................................ ................................ ....................
Figure 21. Subjects Reporting Local Reactions, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age
BNT162b2 Safet y Population ................................ ................................ ....................
Figure 22. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age
BNT162b1 Safet y Population ................................ ................................ ....................
Figure 23. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age
BNT162b1 Safet y Population ................................ ................................ ....................
Figure 24. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age
BNT162b2 Safet y Population ................................ ................................ ....................
Figure 25. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age
BNT162b2 Safet y Population ................................ ................................ ....................
Figure 26. Subjects Reporting Local Reactions, b y Maximum Severity , Within 7 Day s
After Each Dose, Age Group 18- 55 Years Phase 2 Safet y Population ...................
Figure 27. Subjects Reporting Local Reactions, b y Maximum Severity , Within 7 Day s
After Each Dose, Age Group 56- 85 Years Phase 2 Safet y Population ...................
Figure 28. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose, Age Group 18- 55 Years Phase 2 Safety Population ...................
Figure 29. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose, Age Group 56- 85 Years Phase 2 Safet y Population ...................
Figure 30. Subjects Reporting Local Reactions, b y Maximum Severity , Within 7 Day s
After Each Dose, Age Gr oup 16 -55 Years Reactogenicity Subset for Phase 2/3
Analy sis Safet y Population ................................ ................................ ........................
Figure 31. Subjects Reporting Local Reactions, b y Ma ximum Severity , Within 7 Day s
After Each Dose, Age Group >55 Years Reactogenicity Subset for Phase 2/3
Analy sis Safet y Population ................................ ................................ ........................
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CONFIDENTIALFigure 32. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose, Age Group 16- 55 Years Reactogenicity Subset for Phase 2/3
Analy sis Safet y Population ................................ ................................ ........................
Figure 33. Subjects Reporting S ystemic Events, by Maximum Severity , Within 7 Day s
After Each Dose, Age Group >55 Years Reactogenicity Subset for Phase 2/3
Analy sisSafet y Population ................................ ................................ .........................
Figure 34. Forest Plot of Tier 2 Adverse Events Reported From Dose 1 to 1 Month
After Dose 2 - ~38000 Subjects for Phase 2/3 Analy sis -Safet y Population ...............
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CONFIDENTIAL14. TABLES AND FIGURES ............................................................................................... 312
Supplemental Tables ................................ ................................ ................................ ..........
Phase 1 ................................ ................................ ................................ ............................
Conduct of Study ................................ ................................ ................................ .........
14.1. Disposition of All Subjects Phase 1, 2 Doses, 21 Days Apart .....................
14.2. Disposition of All Randomized Subjects Phase 1, 2 Doses, 21 Days Apart
18-55 Years of Age BNT162b1 ................................ ................................ ..
14.3. Disposition of All Randomized Subjects Phase 1 18-55 Years of Age
BNT162b1 (100 μg) ................................ ................................ ..........................
14.4. Disposition of All Randomized Sub jects Phase 1, 2 Doses, 21 Days Apart
65-85 Years of Age BNT162b1 ................................ ................................ ..
14.5. Disposition of All Randomized Subjects Phase 1, 2 Doses , 21 Days Apart
18-55 Years of Age BNT162b2 ................................ ................................ ..
14.6. Disposition of All Randomized Subjects Phase 1, 2 Doses, 21 Days Apart
65-85 Years of Age BNT162b2 ................................ ................................ ..
14.7. Vaccine as Administered b y Vaccine Group Phase 1, 2 Doses, 21 Day s
Apart 18-55 Years of Age BNT162b1 All Randomized Subjects ...........
14.8. Vaccine as Administered b y Vaccine Group Phase 1 18-55 Years of
Age BNT162b1 (100 μg) All Randomized Subjects...................................
14.9. Vaccine as Administered b y Vaccine Group Phase 1, 2 Doses, 21 Day s
Apart 65-85 Years of Age BNT162b1 All Randomized Subjects ...........
14.10. Vaccine Administration Timing Phase 1, 2 Doses, 21 Day s Apart 18-
55 Y ears of Age BNT162b1 All Randomized Subjects..............................
14.11. Vaccine Administration Timing Phase 1, 2 Doses, 21 Day s Apart 65-
85 Years o f Age BNT162b1 All Randomized Subjects..............................
14.12. Vaccine as Administered b y Vaccine Group Phase 1, 2 Doses, 21 Day s
Apart 18-55 Ye ars of Age BNT162b2 All Randomized Subjects ...........
14.13. Vaccine as Administered b y Vaccine Group Phase 1, 2 Doses, 21 Day s
Apart 65-85 Years of Age BNT162b2 All Randomized Subjects ...........
14.14. Vaccine Administration Timing Phase 1, 2 Doses, 21 Day s Apart 18-
55 Yea rs of Age BNT162b2 All Randomized Subjects..............................
14.15. Vaccine Administration Timing Phase 1, 2 Doses, 21 Day s Apart 65-
85 Years of Age BNT162b2 All Randomized Subjects..............................
14.16. Safet y Population Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of
Age BNT162b1 ................................ ................................ ..............................
14.17. Safet y Population Phase 1 18-55 Years of Age BNT162b1 (100 μg) ..
14.18. Safet y Population Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of
Age BNT162b1 ................................ ................................ ..............................
14.19. I mmunogenicit y Populations Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b1................................................................................
14.20. I mmunogenicit y Populations Phase 1 18-55 Years of Age
BNT162b1 (100 μg) ................................ ................................ ..........................
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CONFIDENTIAL14.21. I mmunogenicit y Populations Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b1................................ ................................ ................
14.22. Safet y Population Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of
Age BNT162b2 ................................ ................................ ..............................
14.23. Safet y Population Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of
Age BNT162b2 ................................ ................................ ..............................
14.24. I mmunogenicit y Populations Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b2................................ ................................ ................
14.25. I mmunogenicit y Populations Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b2................................ ................................ ................
14.26. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b1 Safet y Population ................................ ...............
14.27. Demographic Characteristics Phase 1 18-55 Years of Age
BNT162b1 (100 μg) Safety Population ................................ ..........................
14.28. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162 b1 Safet y Population ................................ ...............
14.29. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b1 Dose 1 Al l-Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.30. Demographic Characteristics Phase 1 18-55 Years of Age
BNT162b1 (100 μg) Dose 1 All -Available Immunogenicity Population ......
14.31. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b1 Dose 1 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.32. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b1 Dose 1 Evaluable Immunogenicit y Population ..
14.33. Demographic Characteristics Phase 1 18-55 Years of Age
BNT162b1 (100 μg) Dose 1 Evaluable Immunogenicity Population ............
14.34. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-
85
Years of Age BNT162b1 Dose 1 Evaluable Immunogenicit y Population ..
14.35. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-
55
Years of Age BNT162b1 Dose 2 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.36. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b1 Dose 2 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.37. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b1 Dose 2 Evaluable Immunogenicit y Population ..
14.38. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-
85
Years of Age BNT162b1 Dose 2 Evaluable Immunogenicit y Population ..
14.39. Medical History Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age
BNT162b1 Safet y Population ................................ ................................ .....
14.40. Medical History Phase 1 18-55 Years of Age BNT162b1 (100 μg)
Safety Population ................................ ................................ ..............................
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CONFIDENTIAL14.41. Medical History Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age
BNT162b1 Safet y Population ................................ ................................ .....
14.42. D emographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b2 Safet y Population ................................ ...............
14.43. Demographic Cha racteristics Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b2 Safet y Population ................................ ...............
14.44. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b2 Dose 1 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.45. Demographic Ch aracteristics Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b2 Dose 1 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.46. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b2 Dose 1 Evaluable Immunogenicit y Population ..
14.47. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-
85
Years of Age BNT162b2 Dose 1 Evaluable Immunogenicit y Population ..
14.48. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-
55
Years of Age BNT162b2 Dose 2 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.49. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b2 Dose 2 All -Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.50. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b2 Dose 2 Evaluable Immunogenicit y Population ..
14.51. Demographic Characteristics Phase 1, 2 Doses, 21 Day s Apart 65-
85
Years of Age BNT162b2 Dose 2 Evaluable Immunogenicit y Population ..
14.52. Medical History Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age
BNT162b2 Safet y Population ................................ ................................ .....
14.53. Medical History Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age
BNT162b2 Safet y Population ................................ ................................ .....
14.54. I mmunogenicit y Blood Samples Drawn Phase 1, 2 Doses, 21 Days
Apart 18-55 Years of Age BNT162b1 All Randomized Subjects ...........
14.55. I mmunogenicit y Blood Samples Drawn Phase 1 18-55 Years of Age
BNT162b1 (100 μg) All Randomized Subjects ................................ .............
14.56. I mmunogenicit y Blood Samples Drawn Phase 1, 2 Doses, 21 Days
Apart 65-85 Years of Age BNT162b1 All Randomized Subjects ...........
14.57. I mmunogenicit y Blood Samples Drawn Phase 1, 2 Doses, 21 Days
Apart 18-55 Years of Age BNT162b2 All Randomized Subjects ...........
14.58. Immunogenicit y Blood Samples Drawn Phase 1, 2 Doses, 21 Days
Apart 65-85 Years of Age BNT162b2 All Randomized Subjects ...........
14.59. E- Diary Transmission Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of
Age BNT162b1 Safety Population ................................ ..............................
14.60. E- Diary Transmissi on Phase 1 18- 55 Years of Age BNT162b1 (100
μg) Safety Population ................................ ................................ .....................
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CONFIDENTIAL14.61. E- Diary Transmission Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of
Age BNT162b1 Safety Population ................................ ..............................
14.62. E- Diary Transmission Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of
Age BNT162b2 Safety Population ................................ ..............................
14.63. E- Diary Transmission Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of
Age BNT162b2 Safety Population ................................ ..............................
14.64. Concomitant Vaccines Received From Dose 1 to 1 Month After Dose 2
Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
Immunogenicit y................................ ................................ ................................ ...........
14.65. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 18-55 Years of Age BNT162b1 Evaluable
Immunogenicit y Population ................................ ................................ ..............
14.66. Summary of Geometric Mean Titers/Concentrations Phase 1 18-55
Years of Age BNT162b1 (100 μg) Evaluable Immunogenicit y
Population ................................ ................................ ................................ ..........
14.67. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 65-85 Years of Age BNT162b1 Evaluable
Immunogenicit y Population ................................ ................................ ..............
14.68. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 18-55 Years of Age BNT162b1 All- Available
Immunogenicit y Population ................................ ................................ ..............
14.69. Summary of Geometric Mean Titers/Concentrations Phase 1 18-55
Years of Age BNT162b1 (100 μg) All-Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.70. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 65-85 Years of Age BNT162b1 All- Available
Immunogenicit y Population ................................ ................................ ..............
14.71. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 18-55 Years of Age BNT162b2 Evaluable
Immunogenicit y Popula tion................................ ................................ ..............
14.72. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 65-85 Years of Age BNT162b2 Evaluable
Immunogenicit y Population ................................ ................................ ..............
14.73. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Day s Apart 18-55 Years of Age BNT162b2 All- Available
Immunogenicit y Population ................................ ................................ ..............
14.74. Summary of Geometric Mean Titers/Concentrations Phase 1, 2 Doses,
21 Days Apart 65-85 Years of Age BNT162b2 All- Available
Immunogenicit y Population ................................ ................................ ..............
14.75. Summary of Geometric Mean Fold Rises From B efore Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 18-55
Years of Age BNT162b1 Evaluable Immunogenicity Population ..............
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CONFIDENTIAL14.76. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1 18-55 Years of Age BNT162b1
(100 μg) Evaluable Immunogenicit y Population ................................ ...........
14.77. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b1 Evaluable Immunogenicity Population ..............
14.78. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 18
-55
Years of Age BNT162b1 All- Available Immunogenicity Population ........
14.79. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1 18-55 Years of Age BNT162b1
(100 μg) All
-Available Immunogenicit y Population ................................ .....
14.80. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b1 All- Available Immunogenicity Population ........
14.81. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 18
-55
Years of Age BNT162b2 Evaluable Immunogenicity Population ..............
14.82. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 65
-85
Years of Age BNT162b2 Evaluable Immunogenicity Population ..............
14.83. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 1, 2 Doses, 21 Day s Apart 18
-55
Years of Age BNT162b2 All- Available Immunogenicity Population ........
14.84. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase
1, 2 Doses, 21 Day s Apart 65-85
Years of Age BNT162b2 All- Available Immunogenicity Population ........
14.85. Number (%) of Subjects Achie ving a ≥
4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1, 2 Doses, 21 Day s
Apart –18-55 Years of Age – BNT162b1 –Evaluable Immunogenicity
Population ................................ ................................ ................................ ..........
14.86. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1 –18-55 Years of
Age –BNT162b1 (100 μg) –Evaluable Immunogenicity Population ........
14.87. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1, 2 Doses, 21 Day s
Apart –65-85Years of Age – BNT162b1 –Evaluable Immunogenicity
Population ................................ ................................ ................................ ..........
14.88. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vacci nation to Each Subsequent Time Point – Phase 1, 2 Doses, 21 Day s
Apart –18-55 Years of Age – BNT162b1 –All-Available
Immunogenicit y Population ................................ ................................ ..............
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CONFIDENTIAL14.89. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1 –18-55 Years of
Age –BNT162b1 (100 μg) –All-Available Immunogenicit y Population ..
14.90. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1, 2 Doses, 21 Day s
Apart –65-85 Years of Age – BNT162b1 –All-Availabl e
Immunogenicit y Population ................................ ................................ ..............
14.91. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Poin t –Phase 1, 2 Doses, 21 Day s
Apart –18-55 Years of Age – BNT162b2 –Evaluable Immunogenicity
Population ................................ ................................ ................................ ..........
14.92. Number (%) of Subjects Achieving a ≥4- Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1, 2 Doses, 21 Day s
Apart –65-85 Years of Age – BNT162b2 –Evaluable Immunogenicity
Population ................................ ................................ ................................ ..........
14.93. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1, 2 Doses, 21 Day s
Apart –18-55 Years of Age – BNT162b2 –All-Available
Immunogenicit y Population ................................ ................................ ..............
14.94. Number (%) of Subjects Achieving a ≥4-Fold Rise From Before
Vaccination to Each Subsequent Time Point –Phase 1, 2 Dos es, 21 Day s
Apart –65-85 Years of Age – BNT162b2 –All-Available
Immunogenicit y Population ................................ ................................ ..............
14.95. Summary of Geometric Mean Ratios Phase 1, 2 Doses, 21 Days Apart
18-55 Years of Age BNT162b1 Evaluable Immunogenicit y Population ...
14.96. Summary of Geometric Mean R atios Phase 1, 2 Doses, 21 Day s Apart
65-85 Years of Age BNT162b1 Evaluable Immunogenicit y Population ...
14.97. Summary of Geometr ic Mean Ratios Phase 1 18-55 Years of Age
BNT162b1 (100 μg) Evaluable Immunogenicity Population ........................
14.98. Summary of Geometric Mea n Ratios Phase 1, 2 Doses, 21 Day s Apart
18-55 Years of Age BNT162b1 All- Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.99. Summary of Geometric Mean Ratios Phase 1 18-55 Years of Age
BNT162b1 (100 μg) All-Available Immunogenicity Population ..................
14.100. Summary of G eometric Mean Ratios Phase 1, 2 Doses, 21 Day s Apart
65-85 Years of Age BNT162b1 All-Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.101 . Summary of Geometric Mean Ratios Phase 1, 2 Doses, 21 Day s Apart
18-55 Years of Age BNT162b2 Evaluable Immunogenicit y Population
14.102. Summary of Geometric Mean Ratios Phase 1, 2 Doses, 21 Day s Apart
65-85 Years of Age BNT162b2 Evaluable Immunogenicit y Population
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CONFIDENTIAL14.103. Summary of Geometric Mean Ratios Phase 1, 2 Doses, 21 Day s Apart
18-55 Years of Age BNT162b2 All-Available I mmunogenicity
Population ................................ ................................ ................................ ..........
14.104. Summary of Geometric Mean Ratios Phase 1, 2 Doses, 21 Day s Apart
65-85 Years of Age BNT162b2 All-Available I mmunogenicity
Population ................................ ................................ ................................ ..........
Local Reactions................................ ................................ ................................ ............
14.105. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.106. L ocal Reactions, by Maximum Severity , With in 7 Day s After Dose 1
Phase 1 18-55 Years of Age BNT162b1 (100 μg) Safety Population ......
14.107. L ocal Reactions, by Maximum Sever ity, Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.108. Onset Days for Local Reactions Phase 1, 2 Doses, 21 Day s Apart 18-
55 Years of Age BNT162b1 Safet y Population ................................ ..........
14.109. Onset Day s for Local Reactions Phase 1 18-55 Years of Age
BNT162b1 (100 μg) Safety Population ................................ ..........................
14.110. Onset Day s for Local Reactions Phase 1, 2 Doses, 21 Day s Apart 65-
85 Years of Age BNT162b1 Safet y Population ................................ ..........
14.111. Duration (Day s) From First to Last Day of L ocal Rea ctions Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b1 Safet y
Population ................................ ................................ ................................ ..........
14.112. Duration (Day s) From First to Last Day of L ocal Reactions Phase 1
18-55 Years of Age BNT162b1 (100 μg) Safety Population ......................
14.113. Duration (Day s) From First to La st Day of L ocal Reactions Phase 1, 2
Doses, 21 Day s Apart 65-85 Years of Age BNT162b1 Safet y
Population ................................ ................................ ................................ ..........
14.114. L ocal Reactions , by Maximum Severity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.115. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.116. Onset Day s for Local Reactions Phase 1, 2 Doses, 21 Day s Apart 18-
55 Years of Age BNT162b2 Safet y Population ................................ ..........
14.117. Onset Day s for Local Reactions Phase 1, 2 Doses, 21 Day s Apart 65-
85 Years of Age BNT162b2 Safet y Population ................................ ..........
14.118. Duration (Day s) From First to Last Day of L ocal Reactions Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b2 Safet y
Population ................................ ................................ ................................ ..........
14.119. Duration (Day s) From First to Last Day of L ocal Reactions Phase 1, 2
Doses, 21 Day s Apart 65-85 Years of Age BNT162b2 Safet y
Population ................................ ................................ ................................ ..........
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CONFIDENTIALSystemic Events ................................ ................................ ................................ ...........
14.120. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.121. Sy stemic Events, by Maximum Severity , Within 7 Day s After Dose 1
Phase 1 18-55 Years of Age BNT162b1 (100 μg) Safety Population ......
14.122. Sy stemic Events, by Maximum Se verity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.123. Ons et Day s for Sy stemic Events Phase 1, 2 Doses, 21 Day s Apart 18-
55 Years of Age BNT162b1 Safet y Population ................................ ..........
14.124. Onset Day s for Systemic Events Phase 1 18-55 Years of Age
BNT162b1 (100 μg) Safety Population ................................ ..........................
14.125. Duration (Day s) From First to Last Day of Sy stemic Events Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b1 Safet y
Population ................................ ................................ ................................ ..........
14.126. Duration (Day s) From First to Last Day of Sy stemic Events Phase 1
18-55 Years of Age BNT162b1 (100 μg) Safety Population ......................
14.127. Onset Day s for Sy stemic Events Phase 1, 2 Doses, 21 Day s Apart 65-
85 Years of Age BNT162b1 Safet y Population ................................ ..........
14.128. Duration (Day s) From First to Last Day of Sy stemic Events Phase 1, 2
Doses, 21 Day s Apart 65-85 Years of Age BNT162b1 Safet y
Population ................................ ................................ ................................ ..........
14.129. Sy stemic Eve nts, by Maximum Severity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.130. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each Dose
Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.131. Onset Day s for Sy stemic Events Phase 1, 2 Doses, 21 Day s Apart 18-
55 Years of Age BNT162b2 Safet y Population ................................ ..........
14.132. Duration (Day s) From First to Last Day of Sy stemic Events Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b2 Safet y
Population ................................ ................................ ................................ ..........
14.133. Onset Day s for Sy stemic Events Phase 1, 2 Doses, 21 Day s Apart 65-
85 Years of Age BNT162b2 Safet y Population ................................ ..........
14.134. Duration (Day s) From First to Last Day of Sy stemic Events Phase 1, 2
Doses, 21 Day s Apart 65-85 Years of Age BNT162b2 Safet y
Population ................................ ................................ ................................ ..........
Adverse Events ................................ ................................ ................................ ............
14.135. Number (%) of Subjects Reporting at Least 1 Adverse Event After Dose
1 Phase 1, 2 Doses, 21 Day s Apart 18 -55 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
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CONFIDENTIAL14.136. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Before Dose 2 Phase 1 18-55 Years of Age BNT162b1 (100 μg)
Safety Population ................................ ................................ ..............................
14.137. Num ber (%) of Subjects Reporting at Least 1 Adverse Event After Dose
1 Phase 1, 2 Doses, 21 Day s Apart 65 -85 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.138. Number (%) of Subjects Reporting at Least 1 Adverse Event After Dose
1 Phase 1, 2 Doses, 21 Day s Apart 18 -55 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.139. Number (%) of Subjects Reporting at Least 1 Adverse Event After Dose
1 Phase 1, 2 Doses, 21 Day s Apart 65 -85 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.140. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020) Phase 1 18-55 Years of Age
BNT162b2 (30 μg) Safety Population ................................ ...........................
14.141. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020) Phase 1 65-85 Years of Age
BNT162b2 (30 μg) Safety Population ................................ ...........................
14.142. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term
Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.143. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 3 Weeks After Dose 1, by System Organ Class and Preferred Term
Phase 1 18-55 Years of Age BNT162b1 (100 μg) Safety Population ......
14.144. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term
Phase 1, 2 Doses, 21 Days Apar t 65-85 Years of Age BNT162b1
Safety Population ................................ ................................ ..............................
14.145. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term
Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.146. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term
Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age BNT162b2
Safety Population ................................ ................................ ..............................
14.147. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term Phase 1 18-55 Years of Age BNT162b2 (30 μg) Safet y
Population ................................ ................................ ................................ ..........
14.148. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term Phase 1 65-85 Years of Age BNT162b2 (30 μg) Safet y
Population ................................ ................................ ................................ ..........
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CONFIDENTIAL14.149. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Safety Population ................................ ................................ ...........................
14.150. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to 3 Weeks After Dose 1, b y System Organ Class and Preferred
Term Phase 1 18-55 Years of Age BNT162b1 (100 μg) Safet y
Population ................................ ................................ ................................ ..........
14.151. Number (%) of Subjects Reporti ng at Least 1 Related Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Safety Population ................................ ................................ ...........................
14.152. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Safety Population ................................ ................................ ...........................
14.153. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to 1 Month After Dose 2, by System Organ Class and Preferred
Term Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2
Safety Population ................................ ................................ ...........................
14.154. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 1, b y System Organ Class and Preferred Term Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b1 Safet y
Population ................................ ................................ ................................ ..........
14.155. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 1, b y System Organ Class and Preferred Term Phase 1, 2
Doses, 21 Days Apart 65-85 Years of Age BNT162b1 Safet y
Population ................................ ................................ ................................ ..........
14.156. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 1, b y System Organ Class and Preferred Term Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b2 Safet y
Population ................................ ................................ ................................ ..........
14.157. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 2, b y System Organ Class and Preferred Term Phase 1, 2
Doses, 21 Day s Apart 18-55 Years of Age BNT162b2 Safet y
Population ................................ ................................ ................................ ..........
14.158. Number (%) of Subjects Reporting at Least 1 Severe or Life -Threatening
Adverse Event From Dose 1 to 1 Month After Dose 2, by S ystem Organ
Class and Preferred Ter m Phase 1, 2 Doses, 21 Day s Apart 1855 Years
of Age BNT162b1 Safet y Population ................................ .........................
14.159. Number (%) of Subjects Reporting at Lea st 1 Severe or Life -Threatening
Adverse Event From Dose 1 to 3 Weeks After Dose 1, by S ystem Organ
Class and Preferred Term Phase 1 18-55 Years of Age BNT162b1 (100
μg) Safety Population ................................ ................................ .....................
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CONFIDENTIAL14.160. Number (%) of Subjects Reporting at Least 1 Severe or Life -Threatening
Adverse Event From Dose 1 to 1 Month After Dose 2, by S ystem Organ
Class and Preferred Term Phase 1, 2 Doses, 21 Da ys Apart 6585 Years
of Age BNT162b1 Safet y Population ................................ .........................
14.161. Number (%) of Subjects Reporting at Least 1 Severe or Life -Threate ning
Adverse Event From Dose 1 to 1 Month After Dose 2, by S ystem Organ
Class and Preferred Term Phase 1, 2 Doses, 21 Day s Apart 18-55 Years
of Age BNT162b2 Safet y Population ................................ .........................
14.162. Number (%) of Subjects Reporting at Least 1 Severe or Life -Threatening
Adverse Event From Dose 1 to 1 Month After Dose 2, by S ystem Organ
Class and Preferred Term Phase 1, 2 Doses, 21 Day s Apart 65-85 Years
of Age BNT162b2 Safet y Population ................................ .........................
Clinical L aboratory Evaluations ................................ ................................ ..................
14.163. Percentage of Laboratory Test Abnormalities Phase 1, 2 Doses, 21
Days Apart 18-55 Years of Age BNT162b1 Safety Population ..............
14.164. Shift Summary of Laboratory Results by Grade Phase 1, 2 Doses, 21
Days Apart 18-55 Years of Age BNT162b1 Safety Population ..............
14.165. Percentage of Laboratory Test Abnormalities Phase 1 18-55 Years of
Age BNT162b1 (100 μg) Safet y Population ................................ ...............
14.166. Shift Summary of Laboratory Results by Grade Phase 1 18-55 Years
of Age BNT162 b1 (100 μg) Safety Population ................................ ...........
14.167. Percentage of Laboratory Test Abnormalities Phase 1, 2 Doses, 21
Days Apart 65-85 Years of Age BNT162b1 Safety Population ..............
14.168. Shift Summary of Laboratory Results by Grade Phase 1, 2 Doses, 21
Days Apart 65-85 Years of Age BNT162b1 Safety Population ..............
14.169. Percentage of Laboratory Test Abnormalities Phase 1, 2 Doses, 21
Days Apart 18-55 Years of Age BNT162b2 Safety Population ..............
14.170. Shift Summary of Laboratory Results by Grade Phase 1, 2 Doses, 21
Days Apart 18-55 Years of Age BNT162b2 Safety Population ..............
14.171. Percentage of Laboratory Test Abnormalities Phase 1, 2 Doses, 21
Days Apart 65-85 Years of Age BNT162b2 Safety Population ..............
14.172. Shift Summary of Laboratory Results by Grade Phase 1, 2 Doses, 21
Days Apart 65-85 Years of Age BNT162b2 Safety Population ..............
Physical Examinations ................................ ................................ ................................ .
14.173. Phy sical Examination Findings at Baseline Phase 1, 2 Doses, 21 Day s
Apart 18-55 Years of Age BNT162b1 All Randomized Subjects ...........
14.174. Abnormal Phy sical Examination Findings After Randomization Phase
1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1 All
Randomized Subjects ................................ ................................ ........................
14.175. Phy sical Examination Findings at Baseline Phase 1 18-55 Years of
Age BNT162b1 (100 μg) All Randomized Subjects...................................
14.176. Abnormal Phy sical Examination Findings From Dose 1 to 3 Weeks After
Dose 1 Phase 1 18-55 Years of Age BNT162b1 (100 μg) All
Randomized Subjects ................................ ................................ ........................
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CONFIDENTIAL14.177. Phy sical Examination Findings at Baseline Phase 1, 2 Doses, 21 Day s
Apart 65-85 Years of Age BNT162b1 All Randomized Subjects ...........
14.178. Abnormal Phy sical Examination Findings After Randomization Phase
1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1 All
Randomized Subjects ................................ ................................ ........................
14.179. Phy sical Examination Findings at Baseline Phase 1, 2 Doses, 21 Day s
Apart 18-55 Years of Age BNT162b2 All Randomized Subjects ...........
14.180. Abnormal Phy sical Examination Findings After Randomization Phase
1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2 All
Randomized Subjects ................................ ................................ ........................
14.181. Phy sical Examination Findings at Baseline Phase 1, 2 Doses, 21 Day s
Apart 65-85 Years of Age BNT162b2 All Randomized Subjects ...........
14.182. Abnormal Phy sical Examination Findings After Randomization Phase
1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2 All
Randomized Subjects ................................ ................................ ........................
Phase 2 ................................ ................................ ................................ ............................
Conduct of Study ................................ ................................ ................................ .........
14.183. Disposition of All Randomized Subje cts, by Age Group Phase 2 Age
Group: 18- 55 Years ................................ ................................ ...........................
14.184. Disposition of All Randomized Subjects, by Age Group Phase 2 Age
Group: 56- 85 Years ................................ ................................ ...........................
14.185. Vaccine as Administered b y Vaccine Group Phase 2 All Randomized
Subjects ................................ ................................ ................................ .............
14.186. Vaccine Administration Timing Phase 2 All Randomized Subjects.....
14.187. I mmunogenicit y Populations Phase 2 ................................ ......................
14.188. Demographic Characteristics, b y Age Group Phase 2 Safet y
Population Age Group: 18 -55 Years ................................ ................................ .
14.189. Demographic Characteristics, b y Age Group Phase 2 Safet y
Population Age Group: 56 -85 Years ................................ ................................ .
14.190. Medical History Phase 2 Safet y Population ................................ ..........
14.191. Demographic Characteristics Phase 2 Dose 2 Evaluable
Immunogenicit y Population ................................ ................................ ..............
14.192. Demographic Characteristics Phase 2 Dose 2 All -Available
Immunogenicit y Population ................................ ................................ ..............
14.193. I mmunogenicit y Blood Samples Drawn Phase 2 All Randomized
Subjects ................................ ................................ ................................ .............
14.194. E- Diary Transmission Phase 2 Safety Population ................................ .
Immunogenicit y................................ ................................ ................................ ...........
14.195. Summary of Geometric Mean Titer s/Concentrations Phase 2 Dose 2
Evaluable Immunogenicity Population ................................ .............................
14.196. Summary of Geometric Mean Titers NT90 Phase 2 Dose 2
Evaluable Immunogenicity Population ................................ .............................
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CONFIDENTIAL14.197. Summary of Geometric Mean Titers/Concentrations Phase 2 Dose 2
All-Available Immuno genicity Population ................................ .......................
14.198. Summary of Geometric Mean Titers NT90 Phase 2 Dose 2 All -
Available Immunogenicity Population ................................ ..............................
14.199. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 2 Dose 2 Evaluable Immunogenicity
Population ................................ ................................ ................................ ..........
14.200. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point NT90 Phase 2 Dose 2 Evaluable
Immunogenicit y Population ................................ ................................ ..............
14.201. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point Phase 2 Dose 2 All -Available
Immunogenicit y Population ................................ ................................ ..............
14.202. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point NT90 Phase 2 Dose 2 All -Available
Immunogenicit y Population ................................ ................................ ..............
14.203. Summary of Geometric Mean Titers/Conc entrations by Baseline SARS -
CoV -2 Status Phase 2 Dose 2 Evaluable Immunogenicity Population .......
14.204. Summary of Geometric Mean Titer s by Baseline SARS -CoV -2 Status
NT90 Phase 2 Dose 2 Evaluable Immunogenicity Population ...................
14.205. Summary of Geometric Mean Titers/Concentrations by Baseline SARS -
CoV -2 Status Phase 2 Dose 2 All -Available Immunogenicit y Population .
14.206. Summary of Geometric Me an Titers b y Baseline SARS -CoV -2 Status
NT90 Phase 2 Dose 2 All -Available Immunogenicity Population .............
14.207. Summary of Geometric Mean Titers/Concentrations Positive SARS -
CoV -2 Prior to 1 Month After Dose 2 Phase 2 Dose 2 All -Available
Immunogenicit y Population ................................ ................................ ..............
14.208. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point by Baseline SARS -CoV -2 Status Phase 2
Dose 2 Evaluable Immunogenicity Population ................................ .................
14.209. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point by Baseline SARS -CoV -2 Status NT90
Phase 2 Dose 2 Evaluable I mmunogenicity Population ................................ .
14.210. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Point by Baseline SARS -CoV -2 Status Phase 2
Dose 2 All-Available Immunogenicit y Population ................................ ...........
14.211. Summary of Geometric Mean Fold Rises From Before Vaccination to
Each Subsequent Time Po int by Baseline SARS -CoV -2 Status NT90
Phase 2 Dose 2 All -Available Immunogenicit y Population ...........................
14.212. Summary of Geometric Mean F old Rises From Before Vaccination to
Each Subsequent Time Point Positive SARS -CoV -2 Prior to 1 Month After
Dose 2 Phase 2 Dose 2 All -Available Immunogenicity Population ...........
Local Reactions................................ ................................ ................................ ............
14.213. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose
Phase 2 Safet y Population ................................ ................................ ...........
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CONFIDENTIAL14.214. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose,
by Age Group Phase 2 Safety Population ................................ ...................
14.215. Onset Day s for Local Reactions Phase 2 Safety Population .................
14.216. Onset Day s for Local Reactions, b y Age Group Phase 2 Safety
Population ................................ ................................ ................................ ..........
14.217. Duration (Day s) From First to Last Day of L ocal Reactions Phase 2
Safety Population ................................ ................................ ..............................
14.218. Duration (Day s) From First to Last Day of L ocal Reactions, by Age
Group Phase 2 Safety Population ................................ ................................
Systemic Events ................................ ................................ ................................ ...........
14.219. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each Dose
Phase 2 Safet y Population ................................ ................................ ...........
14.220. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each
Dose, b y Age Group Phase 2 Safet y Population ................................ .........
14.221. Onset Day s for Sy stemic Events Phase 2 Safety Population ................
14.222. Onset Day s for Systemic Events, by Age Group Phase 2 Safety
Population ................................ ................................ ................................ ..........
14.223. Duration (Day s) From First to Last Day of Sy stemic Events Phase 2
Safety Population ................................ ................................ ..............................
14.224. Duration (Day s) From First to Last Day of Sy stemic Events, b y Age
Group Phase 2 Safety Population ................................ ................................
Adverse Events ................................ ................................ ................................ ............
14.225. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 7 Day s After Dose 2 Phase 2 Safet y Population ................................ ..
14.226 . Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020) Phase 2 Safety Population ...............
14.227. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y Age Group Phase 2 Safet y
Population Age Group: 18 -55 Years ................................ ................................ .
14.228. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y Age Group Phase 2 Safet y
Population Age Group: 56 -85 Years ................................ ................................ .
14.229. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 7 Day s After Dose 2, by System Organ Class and Preferred Term, b y
Age Group Phase 2 Safety Population Age Group: 18 -55 Years ...............
14.230. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 7 Day s After Dose 2, by System Organ Class and Preferred Term, b y
Age Group Phase 2 Safet y Population Age Group: 56 -85 Years ...............
14.231. Number (%) of S ubjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term Phase 2 Safety Population ................................ ................................ .
14.232. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term, b y Age Group Phase 2 Safet y Population Age Group: 18 -55 Years
Page 31
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CONFIDENTIAL14.233. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term, b y Age Group Phase 2 Safet y Population Age Group: 56 -85 Years
14.234. Number (%) of Subjects Reporting at Least 1 Related Adve rse Event
From Dose 1 to 7 Day s After Dose 2, by System Organ Class and Preferred
Term Phase 2 Safety Population ................................ ................................ .
14.235. Number (%) of Subjects Reporting at Least 1 Severe or Life -Threatening
Adverse Event From Dose 1 to 7 Day s After Dose 2, by System Organ Class
and Preferred Term Phase 2 Safet y Population ................................ ...........
14.236. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 7 Day s After Dose 2, by System Organ Class and Preferred
Term, b y Age Group Phase 2 Safet y Population Age Group: 18 -55 Years
14.237. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 7 Day s After Dose 2, by System Organ Class and Preferred
Term, b y Age Group Phase 2 Safet y Population Age Group: 56 -85 Years
14.238. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term Phase 2 Safet y Population ................................ ...........
14.239. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Phase 2 Safet y Population Age
Group: 18- 55 Years ................................ ................................ ...........................
14.240. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferr ed Term, by Age Group Phase 2 Safet y Population Age
Group: 56- 85 Years ................................ ................................ ...........................
14.241. Number (%) of Subjects Withdrawn Because of Adverse Events From
Dose 1 to 7 Day s After Dose 2, by System Organ Class and Preferred Term
Phase 2 Safet y Population ................................ ................................ ...........
Phase 2/3 ................................ ................................ ................................ .........................
Conduct of Study ................................ ................................ ................................ .........
14.242. Disposition of All Randomized Subjects, by Age Group ~38000
Subjects for Phase 2/3 Analy sis Age Group: 16 -55 Years ................................
14.243. Disposition of All Randomized Subjects, by Age Group ~38000
Subjects for Phase 2/3 Analy sis Age Group: >55 Years ................................ ...
14.244. Disposition of All Ran domized Subjects, by Baseline SARS -CoV -2
Status ~38000 Subjects for Phase 2/3 Anal ysis Baseline SARS -CoV -2
Status: Positive ................................ ................................ ................................ ..
14.245. D isposition of All Randomized Subjects, by Baseline SARS -CoV -2
Status ~38000 Subjects for Phase 2/3 Anal ysis Baseline SARS -CoV -2
Status: Negative ................................ ................................ ................................ .
14.246. Disposition of All Randomized Subjects, by Baseline SARS -CoV -2
Status and Age Group ~38000 Subjects for Phase 2/3 Anal ysis Baseline
SARS -CoV -2 Status: Positive Age Group: 16 -55 Years ................................ ..
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CONFIDENTIAL14.247. Disposition of All Randomized Subjects, by Baseline SARS -CoV -2
Status and Age Group ~38000 Subjects for Phase 2/3 Anal ysis Baseline
SARS -CoV -2 Status: Positive Age Group: >55 Y ears................................ .....
14.248. Disposition of All Randomized Subjects, by Baseline SARS -CoV -2
Status and Age Group ~38000 Subjects for Phase 2/3 Anal ysis Baseline
SARS -CoV -2 Status: Negative Age Group: 16- 55 Years ................................ .
14.249. Disposition of All Randomized Subjects, by Baseline SARS -CoV -2
Status and Age Group ~38000 Subjects for Phase 2/3 Anal ysis Baseline
SARS -CoV -2 Status: Negative Age Group: >55 Years ................................ ....
14.250. Disposit ion of All Randomized Subjects, by Ethnicit y ~38000 Subjects
for Phase 2/3 Anal ysis Ethnicity : Hispanic/Latino ................................ ...........
14.251. Disposition of All Randomized Subjects, by Ethnicit y ~38000 Subjects
for Phase 2/3 Anal ysis Ethnicity : Non -Hispanic/Non -Latino ...........................
14.252. Disposition of All Randomized Subjects, by Ethnicit y ~38000 Subjects
for Phase 2/3 Anal ysis Ethnicity : Not Reported ................................ ...............
14.253. Disposition of All Ra ndomized Subjects, by Race ~38000 Subjects for
Phase 2/3 Anal ysis Race: White ................................ ................................ ........
14.254. Disposition of All Randomized Subjects, by Race ~38000 Subjects for
Phase 2/3 Anal ysis Race: Black or African American ................................ ......
14.255. Disposition of All Randomized Subjects, by Race ~38000 Subjects for
Phase 2/3 Anal ysis Race: All Others ................................ ................................ .
14.256. Disposition of All Randomized Subjects, by Sex ~38000 Subjects for
Phase 2/3 Anal ysis Sex: Male ................................ ................................ ...........
14.257. Disposition of All Randomized Subjects, by Sex ~38000 Subjects for
Phase 2/3 Anal ysis Sex: Female ................................ ................................ ........
14.258. Disposition of All Randomized Subjects Phase 2/3 (All Subjects)..........
14.259. Disposition of All Randomized Subjects, by Age Group Phase 2/3 (All
Subjects) Age Group: 16 -55 Years ................................ ................................ ...
14.260. Disposition of All Randomized Subjects, by Age Group Phase 2/3 (All
Subjects) Age Group: >55 Years ................................ ................................ ......
14.261. Safet y Population, by Age Group ~38000 Subjects for Phase 2/3
Analy sis................................ ................................ ................................ .............
14.262. Safet y Population, by Baseline SARS -CoV -2 Status ~38000 Subjects
for Phase 2/3 Anal ysis................................ ................................ .......................
14.263. Safet y Population, by Baseline SARS -CoV -2 Status and Age Group
~38000 Subj ects for Phase 2/3 Anal ysis................................ ...........................
14.264. Safet y Population, by Ethnicit y ~38000 Subjects for Phase 2/3
Analy sis................................ ................................ ................................ .............
14.265. Safet y Population, by Race ~38000 Subjects for Phase 2/3 Analysis ......
14.266. Safet y Population, by Sex ~38000 Subjects for Phase 2/3 Anal ysis........
14.267. Safet y Population Phase 2/3 (All Subjects)..............................................
14.268. Safet y Population, by Age Group Phase 2/3 (All Subjects) .....................
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CONFIDENTIAL14.269. Follow -Up Time After Dose 2 Phase 2/3 (All Subjects) Safet y
Population ................................ ................................ ................................ ..........
14.270. Demographic Characteristics, b y Age Group ~38000 Subjects for
Phase 2/3 Anal ysis Safety Population Age Group: 16- 55 Years ...................
14.271. Demographic Characteristics, b y Age Group ~38000 Subjects for
Phase 2/3 Anal ysis Safety Population Age Group: >55 Years ......................
14.272. Demographic Characteristics, b y Baseline SARS -CoV -2 Status ~38000
Subjects for Phase 2/3 Analy sis Safety Population Baseline SARS -CoV -2
Status: Positive ................................ ................................ ................................ ..
14.273. Demographic Characteristics, b y Baseline SARS -CoV -2 Status ~38000
Subjects for Phase 2/3 Analy sis Safety Population Baseline SARS -CoV -2
Status: Negative ................................ ................................ ................................ .
14.274. Demographic Characteristics, b y Baseline SARS -CoV -2 Status and Age
Group ~38000 Subjects for Phase 2/3 Anal ysis Safety Population
Baseline SARS -CoV -2 Status: Positive Age Group: 16- 55 Years ...................
14.275. Demographic Characteristics, b y Baseline SARS -CoV -2 Status and Age
Group ~38000 Subjects for Phase 2/3 Anal ysis Safety Population
Baseline SARS -CoV -2 Status: Positive Age Group: >55 Years .......................
14.276. Demographic Characteristics, b y Baseline SARS -CoV -2 Status and Age
Group ~38000 Subjects for Phase 2/3 Anal ysis Safety Population
Baseline SARS -CoV -2 Status: Negative Age Group: 16 -55 Years ..................
14.277. Demographic Characteristics, b y Baseline SARS -CoV -2 Status and Age
Group ~38000 Subjects for Phase 2/3 Anal ysis Safety Population
Baseline SARS -CoV -2 Status: Negative Age Group: >55 Years .....................
14.278. Demographic Characteristics, b y Ethnicity ~38000 Subjects for Phase
2/3 Analy sis Safety Population Ethnicity : Hispanic/L atino ...........................
14.279. Demographic Characteristics, b y Ethnicity ~38000 Subjects for Phase
2/3 Analy sis Safety Population Ethnicity : Non- Hispanic/Non- Latino ..........
14.280. Demographic Characteristics, b y Ethnicity ~38000 Subjects for Phase
2/3 Analy sis Safety Population Ethnicity : Not Reported ...............................
14.281. Demographic Characteristics, b y Race ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Race: White ................................ .......................
14.282. Demographic Characteristics, b y Race ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Race: Black or African American ......................
14.283. Demographic Characteristics, b y Race ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Race: All Others ................................ ................
14.284. Demographic Characteristics, b y Sex ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Sex: Male ................................ ...........................
14.285. Demographic Characteristics, b y Sex ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Sex: Female ................................ .......................
14.286. Demographic Characteristics 16-17 Years of Age Safet y Population ..
14.287. Medica l History ~38000 Subjects for Phase 2/3 Anal ysis Safet y
Population ................................ ................................ ................................ ..........
14.288. Baseline Charlson Comorbidities ~38000 Subjects for Ph ase 2/3
Analy sis Safet y Population ................................ ................................ ............
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CONFIDENTIAL14.289. Baseline Charlson Comorbidities, by Age Group ~38000 Subjects for
Phase 2/3 Anal ysis Safety Population Age Group: 16- 55 Years ...................
14.290. Baseline Charlson Comorbidities, by Age Group ~38000 Subjects for
Phase 2/3 Anal ysis Safety Population Age Group: >55 Years ......................
14.291. Demographic Characteristics Phase 2/3 (All Subjects) Safety
Population ................................ ................................ ................................ ..........
14.292. Demographic Characteristics, b y Age Group Phase 2/3 (All Subjects)
Safety Population Age Group: 16- 55 Years ................................ ......................
14.293. Demographic Characteristics, b y Age Group Phase 2/3 (All Subjects)
Safety Population Age Group: >55 Years ................................ .........................
14.294. Medical History Phase 2/3 (All Subjects) Safet y Population ................
14.295. Baseline Charlson Comorbidities Phase 2/3 (All Subjects) Safety
Population ................................ ................................ ................................ ..........
14.296. Baseline Charlson Comorbid ities, by Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: 16 -55 Years ................................ ...
14.297. Baseline Charlson Comorbidities, by Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: >55 Years ................................ ......
14.298. Demographic Characteristics Subjects Without Evi dence of I nfection
Prior to 7 Day s After Dose 2 Dose 2 All -Available Efficacy Population
Interim Anal ysis 1................................ ................................ .............................
14.299. Demographic Cha racteristics Subjects Without Evidence of I nfection
Prior to 7 Day s After Dose 2 Dose 2 All -Available Efficacy Population ......
14.300. D emographic Characteristics Subjects Without Evidence of I nfection
Prior to 14 Day s After Dose 2 Evaluable Efficacy (14 Day s) Population .....
14.301. Demographic Characteristics Dose 1 All -Available Efficacy Population
14.302. Demographic Characteristics Subjects With or Without Evidence of
Infection Prior to 7 Day s After Dose 2 Evaluable Efficacy (7 Day s)
Population ................................ ................................ ................................ ..........
14.303. Demographic Characteris tics Subjects With or Without Evidence of
Infection Prior to 7 Day s After Dose 2 Dose 2 All -Available Efficacy
Population ................................ ................................ ................................ ..........
14.304. D emographic Characteristics Subjects With or Without Evidence of
Infection Prior to 14 Days After Dose 2 Evaluable Efficacy (14 Day s)
Population ................................ ................................ ................................ ..........
14.305. E- Diary Transmission Reactogenicity Subset for Phase 2/3 Analy sis
Safety Population ................................ ................................ ..............................
14.306. Concomitant Vaccin es Received After Dose 1 ~38000 Subjects for
Phase 2/3 Anal ysis Safety Population ................................ ............................
14.307. Concomitant Vaccines Received After Dose 1 Phase 2/3 (All Subjects)
Safety Population ................................ ................................ ...........................
Efficacy ................................ ................................ ................................ ........................
14.308. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After
Dose 2 Subjects Without Evidence of Infection Prior to 7 Day s After Dose
2 Dose 2 All -Available Efficacy Population Interim Analy sis 1 ................
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CONFIDENTIAL14.309. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After
Dose 2, b y Subgroup Subjects Without Evidence of Infection Pri or to 7
Days After Dose 2 Dose 2 All -Available Efficacy Population Interim
Analy sis 1 ................................ ................................ ................................ ..........
14.310. Summary of Signs and Sy mptoms for Sev ere COVID -19 Occurrence
From 7 Day s After Dose 2 Subjects With or Without Evidence of Infection
Prior to 7 Day s After Dose 2 Evaluable Efficacy (7 Day s) Population .........
14.311. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infection Prior to 7 Days
After Dose 2 by Age Group Evaluable Efficacy (7 Day s) Population Age
Group: 16-55 Years ................................ ................................ ...........................
14.312. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infe ction Prior to 7 Days
After Dose 2 by Age Group Evaluable Efficacy (7 Day s) Population Age
Group: >55 Years ................................ ................................ ..............................
14.313. Summary of Sign s and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 – Subjects Without Evidence of Infection Prior to 7
Days After Dose 2 – by Age Group – Evaluable Efficacy (7 Day s)
Population Age Group: ≥65 Years ................................ ................................ ..
14.314. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infection Prior to 7 Days
After Dose 2 Dose 2 All -Available Efficacy Population ...............................
14.315. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infection Prior to 7 Days
After Dose 2 by Age Group Dose 2 All -Available Efficacy Population
Age Group: 16 -55 Years ................................ ................................ ...................
14.316. Summ ary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infection Prior to 7 Days
After Dose 2 by Age Group Dose 2 All -Available Efficacy Population
Age Group: >55 Years ................................ ................................ ......................
14.317. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 – Subjects Without Evidence of Infection Prior to 7
Days After Dose 2 – by Age G roup –Dose 2 All -Available Efficacy
Population Age Group: ≥65 Years ................................ ................................ ..
14.318. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
7 Day s After Dose 2 by Age Group Evaluable Efficacy (7 Day s)
Population Age Group: 16 -55 Years ................................ ................................ .
14.319. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
7 Day s After Dose 2 by Age Group Evaluable Efficacy (7 Day s)
Population Age Group: >55 Years ................................ ................................ ....
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CONFIDENTIAL14.320. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 – Subjects With or Without Evidence of Infection Prior
to 7 Day s After Dose 2 –by Age Group – Evaluable Efficacy (7 Day s)
Population Age Group: ≥65 Years ................................ ................................ ..
14.321. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
7 Day s After Dose 2 Dose 2 All -Available Efficacy Population ...................
14.322 . Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
7 Day s After Dose 2 by Age Group Dose 2 All -Available Efficacy
Population Age Group: 16 -55 Years ................................ ................................ .
14.323. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
7 Day sAfter Dose 2 by Age Group Dose 2 All -Available Efficacy
Population Age Group: >55 Years ................................ ................................ ....
14.324. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 7
Days After Dose 2 – Subjects With or Without Evidence of Infection Prior
to 7 Day s After Dose 2 –by Age Group – Dose 2 All -Available Efficacy
Population Age Group: ≥65 Years ................................ ................................ ..
14.325. Summary of Signs and Sy mptoms for COVID -19 Occurrence After Dose
1 by Age Group Dose 1 All -Available Efficacy Population Age Group:
12-15 Years ................................ ................................ ................................ .......
14.326. Summary of Signs and Sy mptoms for COVID -19 Occurrence After Dose
1 by Age Group Dose 1 All -Available Efficacy Population Age Group:
16-55 Years ................................ ................................ ................................ .......
14.327. Summary of Signs and Sy mptoms for COVID -19 Occurrence After Dose
1 by Age Group Dose 1 All -Available Efficacy Population Age
Group: >55 Years ................................ ................................ ..............................
14.328. Summary of Signs and Sy mptoms for COVID -19 Occurrence After Dose
1 –by Age Group – Dose 1 All -Available Efficacy Popula tion Age
Group: ≥65 Years ................................ ................................ ............................
14.329. Summary of Signs and Sy mptoms for Severe COVID -19 Occurrence
From 14 Day s After Dose 2 Subjects Wit hout Evidence of Infection Prior
to 14 Day s After Dose 2 Evaluable Efficacy (14 Day s) Population ..............
14.330. Summary of Signs and Sy mptom s for Severe COVID- 19 Occurrence
From 14 Day s After Dose 2 Subjects With or Without Evidence of
Infection Prior to 14 Days After Dose 2 Evaluable Efficacy (14 Day s)
Population ................................ ................................ ................................ ..........
14.331. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 Evaluable Efficacy (14 Day s) Population .......................
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CONFIDENTIAL14.332. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects Without Evidence of Infection Prior to 14
DaysAfter Dose 2 by Age Group Evaluable Efficacy (14 Day s)
Population Age Group: 16 -55 Years ................................ ................................ .
14.333. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 by Age Group Evaluable Efficacy (14 Day s)
Population Age Group: >55 Years ................................ ................................ ....
14.334. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 – Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 – by Age Group – Evaluable Efficacy (14 Day s)
Population Age Group: ≥65 Years ................................ ................................ ..
14.335. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 Dose 2 All -Available Efficacy Population ......................
14.336. Summary of Signs a nd Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 by Age Group Dose 2 All -Available Efficacy
Population Age Group: 16 -55 Years ................................ ................................ .
14.337. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 by Age Group Dose 2 All -Available Efficacy
Population Age Group: >55 Years ................................ ................................ ....
14.338. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
DaysAfter Dose 2 – Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 – by Age Group – Dose 2 All -Available Efficacy
Population Age Group: ≥65 Years ................................ ................................ ..
14.339. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
14 Day s After Dose 2 Evaluable Efficacy (14 Day s) Population ..................
14.340. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
14 Day sAfter Dose 2 by Age Group Evaluable Efficacy (14 Day s)
Population Age Group: 16 -55 Years ................................ ................................ .
14.341. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
14 Day s After Dose 2 by Age Group Evaluable Efficacy (14 Day s)
Population Age Group: >55 Years ................................ ................................ ....
14.342. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 – Subjects With or Without Evidence of Infection Prior
to 14 Day s After Dose 2 –by Age Group – Evaluable Effi cacy (14 Day s)
Population Age Group: ≥65 Years ................................ ................................ ..
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CONFIDENTIAL14.343. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
14 Day s After Dose 2 Dose 2 All -Available Efficacy Population .................
14.344. Summa ry of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
14 Day s After Dose 2 by Age Group Dose 2 All -Available Efficacy
Population Age Group: 16 -55 Years ................................ ................................ .
14.345. Summary of Signs and Sy mptoms for COVID -19 Occurrence From 14
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to
14 Day s After Dose 2 by Age Group Dose 2 All -Available Efficacy
Population Age Group: >55 Years ................................ ................................ ....
14.346. Summary of Signs and Sy mptoms for COV ID-19 Occurrence From 14
Days After Dose 2 – Subjects With or Without Evidence of Infection Prior
to 14 Day s After Dose 2 –by Age Group – Dose 2 All -Available Efficacy
Population Age Group: ≥65 Years ................................ ................................ ..
14.347. Summary of Signs and Sy mptoms for COVID -19 Occurrence Based on
CDC -Defined S ymptoms After Dose 1 Dose 1 All -Available Efficacy
Population ................................ ................................ ................................ ..........
14.348. Summary of Signs and Sy mptoms for COVID -19 Occurrence Based on
CDC -Defined S ymptoms From 7 Day s After Dose 2 Subjects Without
Evidence of Infection Prior to 7 Day s Aft er Dose 2 Evaluable Efficacy (7
Days) Population ................................ ................................ ...............................
14.349. Summary of Signs and Sy mptoms for COVID -19 Occurrence Based on
CDC -Defined S ymptoms From 7 Day s After Dose 2 Subjects With or
Without Evidence of I nfection Prior to 7 Day s After Dose 2 Evaluable
Efficacy (7 Day s) Population ................................ ................................ ............
14.350. Summary of Signs and Sy mptoms for COVID -19 Occurrence Based on
CDC -Defined S ymptoms From 14 Day s After Dose 2 Subjects Without
Evidence of Infection Prior to 14 Day s After Dose 2 Evaluable Efficacy
(14 Day s) Population ................................ ................................ .........................
14.351. Summary of Signs and Sy mptoms for COVID -19 Occurrence Based on
CDC -Defined S ymptoms From 14 Day s After Dose 2 Subjects With or
Withou t Evidence of I nfection Prior to 14 Day s After Dose 2 Evaluable
Efficacy (14 Day s) Population ................................ ................................ ..........
14.352. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After
Dose 2, b y Subgroup Subjects Without Evidence of Infection Prior to 7
Days After Dose 2 Dose 2 All -Available Efficacy Population ......................
14.353. Vaccine Efficacy First COVID -19 Occurrence From 7 Day s After
Dose 2, b y Subgroup Subjects With or Without Evidence of Infection Prior
to 7 Day s After Dose 2 Dose 2 All -Available Efficacy Population ...............
14.354. Vaccine Efficacy First COVID -19 Occurrence After Dose 1, b y
Subgroup Dose 1 All -Available Efficacy Population ................................ ....
14.355. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After
Dose 2, b y Subgroup Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 Evaluable Efficacy (14 Day s) Population .......................
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CONFIDENTIAL14.356. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After
Dose 2 Subjects Wi thout Evidence of Infection Prior to 14 Days After
Dose 2 Dose 2 All -Available Efficacy Population ................................ .........
14.357. Vaccine Efficacy First C OVID -19 Occurrence From 14 Day s After
Dose 2, b y Subgroup Subjects Without Evidence of Infection Prior to 14
Days After Dose 2 Dose 2 All -Available Efficacy Population ......................
14.358. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After
Dose 2, b y Subgroup Subjects With or Without Evidence of Infection Prior
to 14 Day s After Dose 2 Evaluable Efficacy (14 Day s) Population ..............
14.359. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After
Dose 2 Subjects With or Without Evidence of Infection Prior to 14 D ays
After Dose 2 Dose 2 All -Available Efficacy Population ...............................
14.360. Vaccine Efficacy First COVID -19 Occurrence From 14 Day s After
Dose 2, b y Subgroup Subjects With or Without Evidence of Infection Prior
to 14 Day s After Dose 2 Dose 2 All -Available Efficacy Population .............
14.361. Vaccine Efficacy First COVID -19 Occurrence Based on CDC- Defined
Symptoms From 14 Days After Dose 2 Subjects With or Without Evidence
of Infection Prior to 14 Day s After Dose 2 Evaluable Efficacy (14 Day s)
Population ................................ ................................ ................................ ..........
14.362. Vaccine Efficacy First COVID -19 Occurrence Based on CDC- Defined
Symptoms From 14 Days After Dose 2 Subjects Without Evidence of
Infection Prior to 14 Days After Dose 2 Evaluable Efficacy (14 Day s)
Population ................................ ................................ ................................ ..........
14.363. COVID -19 Occurrence After Dose 1 Based on CDC -Defined S ymptoms
Dose 1 All -Available Efficacy Population ................................ .....................
Local Reactions................................ ................................ ................................ ............
14.364. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose
Reactogenicity Subset for Phase 2/3 Anal ysis Safety Population ...............
14.365. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose,
by Age Group Reactogenicity Subset for Phase 2/3 Analy sis Safety
Population ................................ ................................ ................................ ..........
14.366. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose,
by Baseline SARS -CoV -2 Status Reactogenicity Subset for Phase 2/3
Analy sis Safet y Population ................................ ................................ ............
14.367. L ocal Reactions, by Maximum Severity , Within 7 Day s After Each Dose,
by Baseline SARS -CoV -2 Status and Age Group Reactogenicit y Sub set
for Phase 2/3 Anal ysis Safety Population ................................ ......................
14.368. Onset Day s for Local Reactions Reactogenicity Subset for Phase 2/3
Analy sis Safet y Population ................................ ................................ ............
14.369. Onset Day s for Local Reactions, b y Age Group Reactogenicity Subset
for Phase 2/3 Anal ysis Safety Populati on ................................ ......................
14.370. Duration (Day s) From First to Last Day of L ocal Reactions
Reactogenicity Subset for Phase 2/3 Anal ysis Safety Population ..................
14.371. Duration (Day s) From First to Last Day of L ocal Reactions, by Age
Group Reactogenicity Subset for Phase 2/3 Analy sis Safet y Population ...
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CONFIDENTIALSystemic Events ................................ ................................ ................................ ...........
14.372. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each Dose
Reactogenicity Subset for Phase 2/3 Anal ysis Safety Population ...............
14.373. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each
Dose, b y Age Group Reactogenicity Subset for Phase 2/3 Anal ysis
Safety Population ................................ ................................ ..............................
14.374. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each
Dose, b y Baseline SARS -CoV -2 Status Reactogenicity Subset for Phase
2/3 Analy sis Safety Population ................................ ................................ ......
14.375. Sy stemic Events, by Maximum Severity , Within 7 Day s After Each
Dose, b y Baseline SARS -CoV -2 Status and Age Group Reactogenicity
Subset for Phase 2/3 Analy sis Safety Population ................................ ...........
14.376. Onset Day s for Sy stemic Events Reactogenicity Subset for Phase 2/3
Analy sis Safet y Population ................................ ................................ ............
14.377. Onset Day s for Sy stemic Events, by Age Group Reactogenicity Subset
for Phase 2/3 Anal ysis Safety Population ................................ ......................
14.378. Duration (Day s) From First to Last Day of Sy stemic Events
Reactogenicity Subset for Phase 2/3 Anal ysis Safety Population ..................
14.379. Duration (Day s) From First to Last Day of Sy stemic Events, b y Age
Group Reactogenicity Subset for Phase 2/3 Analy sis Safet y Population ...
Adverse Events ................................ ................................ ................................ ............
14.380. Number (% ) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Age Group ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Age Group: 16 -55 Years ................................ ....
14.381. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Age Group ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Age Group: >55 Years ................................ .......
14.382. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Baseline SARS -CoV -2 Status ~38000
Subjects for Phase 2/3 Analy sis Safety Population Baseline SARS -CoV -2
Status: Positive ................................ ................................ ................................ ..
14.383. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Baseline SARS -CoV -2 Status ~38000
Subjects for Phase 2/3 Analy sis Safety Population Baseline SARS -CoV -2
Status: Negative ................................ ................................ ................................ .
14.384. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Baseline SARS -CoV -2 Status and Age Group
~38000 Subjects for Phase 2/3 Anal ysis Safet y Population B aseline
SARS -CoV -2 Status: Positive Age Group: 16 -55 Years ................................ ..
14.385. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Baseline SARS -CoV -2 Status and Age Group
~38000 Subjects for Phase 2/3 Anal ysis Safet y Population Baseline
SARS -CoV -2 Status: Positive Age Group: >55 Years ................................ .....
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CONFIDENTIAL14.386. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Baseline SARS -CoV -2 Status and Age Group
~38000 Subjects for Phase 2/3 Anal ysis Safet y Population Baseline
SARS -CoV -2 Status: Negative Age Group: 16- 55 Years ................................ .
14.387. Number (%) of Subjects Reporting at Least 1 Adverse Event Fr om Dose
1 to 1 Month After Dose 2, by Baseline SARS -CoV -2 Status and Age Group
~38000 Subjects for Phase 2/3 Anal ysis Safet y Population Baseline
SARS -CoV -2 Status: Negative Age Group: >55 Years ................................ ....
14.388. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Ethnicit y ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Ethnicity : Hispa nic/Latino................................ .
14.389. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Ethnicit y ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Ethnicity: Non- Hispanic/Non- Latino ................
14.390. Number (%) of Subjects Reporting at Lea st 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Ethnicit y ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Ethnicity : Not Reported ................................ .....
14.391. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Race ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Race: White ................................ .......................
14.392. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Race ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Race: Black or A frican American ......................
14.393. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Race ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Race: All Others ................................ ................
14.394. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Sex ~38000 Subjects for Phase 2/3 Anal ysis
Safety Population Sex: Male ................................ ................................ ..........
14.395. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by Sex ~38000 Subjects for Phase 2/3 Anal ysis
Safety Population Sex: Female ................................ ................................ ......
14.396. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y Age Group Subjects With 2
Months Follow -Up Time After Dose 2 for Phase 2/3 Analy sis Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.397. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y Age Group Subjects With 2
Months Follow -Up Time After Dose 2 for Phase 2/3 Analy sis Safety
Population Age Group: >55 Years ................................ ................................ ....
14.398. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: 16 -55 Years ................................ ...
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CONFIDENTIAL14.399. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: >55 Years ................................ ......
14.400. Tier 2 Adverse Events Reported From Dose 1 to 1 Month After Dose 2,
by System Organ Class and Preferred Term ~38000 Subjects for Phase 2/3
Anal ysis Safet y Population ................................ ................................ ............
14.401. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Age Group ~38000 Subjects for Phase 2/3 Analy sis Safet y Population
Age Group: 16 -55 Years ................................ ................................ ...................
14.402. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Age Group ~38000 Subjects for Phase 2/3 Analy sis Safet y Population
Age Group: >55 Years ................................ ................................ ......................
14.403. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Baseli ne SARS -CoV -2 Status ~38000 Subjects for Phase 2/3 Anal ysis
Safety Population Baseline SARS -CoV -2 Status: Positive ...............................
14.404. Number ( %) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Baseline SARS -CoV -2 Status ~38000 Subjects for Phase 2/3 Anal ysis
Safety Population Baseline SARS -CoV -2 Status: Negative .............................
14.405. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Prefe rred Term, b y
Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects for Phase
2/3 Analy sis Safety Population Baseline SARS -CoV -2 Status: Positive
Age Group: 16 -55 Years ................................ ................................ ...................
14.406. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects for Phas e
2/3 Analy sis Safety Population Baseline SARS -CoV -2 Status: Positive
Age Group: >55 Years ................................ ................................ ......................
14.407. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects for Phase
2/3 Analy sis Safety Population Baseline SARS -CoV -2 Status: Negative
Age Group: 16- 55 Years ................................ ................................ ...................
14.408. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Clas s and Preferred Term, b y
Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects for Phase
2/3 Analy sis Safety Population Baseline SARS -CoV -2 Status: Negative
Age Group: >55 Years ................................ ................................ ......................
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CONFIDENTIAL14.409. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Ethnicity ~38000 Subjects for Phase 2/3 Anal ysis Safet y Population
Ethnicity : Hispanic/Latino ................................ ................................ ................
14.410. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Ethnicity ~38000 Subjects for Phase 2/3 Anal ysis Safety Population
Ethnicity : Non -Hispanic/Non- Latino ................................ ................................
14.411. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Ethnicity ~38000 Subjects for Phase 2/3 Anal ysis Safety Population
Ethnicity : Not Reported ................................ ................................ ....................
14.412. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Race ~38000 Subjects for Phase 2/3 Anal ysis Safety Population Race:
White ................................ ................................ ................................ .................
14.413. Number (%) of Subjects Re porting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Race ~38000 Subjects for Phase 2/3 Anal ysis Safety Population Race:
Black or African American ................................ ................................ ...............
14.414. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Race ~38000 Subjects for Pha se 2/3 Anal ysis Safety Population Race:
All Others ................................ ................................ ................................ ..........
14.415. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Sex ~38000 Subjects for Phase 2/3 Anal ysis Safety Population Sex:
Male ................................ ................................ ................................ ...................
14.416. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 1 Month After Dose 2, by System Organ Class and Preferred Term, b y
Sex ~38000 Subjects for Phase 2/3 Anal ysis Safety Population Sex:
Female ................................ ................................ ................................ ...............
14.417. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term Subjec ts With 2 Months Follow- Up Time After Dose 2 for Phase 2/3
Analy sis Safet y Population ................................ ................................ ............
14.418. Number (%) of Subjects Reporting at Lea st 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term, b y Age Group Subjects With 2 Months Follow- Up Time After Dose
2 for Phase 2/3 Anal ysis Safety Population Age Group: 16 -55 Years ...........
14.419. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term, by Age Group Subjects With 2 Months Follow- Up Time After Dose
2 for Phase 2/3 Anal ysis Safety Population Age Group: >55 Years..............
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CONFIDENTIAL14.42 0. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term Phase 2/3 (All Subjects) Safet y Population ................................ .......
14.421. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Date (14NOV2020), b y System Organ Class and Preferred
Term, b y Age Group Phase 2/3 (All Subjects) Safety Population Age
Group: 16- 55 Years ................................ ................................ ...........................
14.422. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to Data Cutoff Dat e (14NOV2020), by System Organ Class and Preferred
Term, b y Age Group Phase 2/3 (All Subjects) Safety Population Age
Group: >55 Years ................................ ................................ ..............................
14.423. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 7 Day s After Dose 1 (as of Data Cutoff Date of 14NOV2020), by
System Organ Class and Preferred Term Phase 2/3 (All Subjects) Safet y
Population ................................ ................................ ................................ ..........
14.424. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
2 to 7 Day s After Dose 2 (as of Data Cutoff Date of 14NOV2020), by
System Organ Class and Preferred Term Phase 2/3 (All Subjects) Safet y
Population ................................ ................................ ................................ ..........
14.425. Number (%) of Subjects Reporting at Least 1 Adverse Event F rom Dose
1 to 7 Day s After Dose 1 (as of Data Cutoff Date of 14NOV2020), by
System Organ Class and Preferred Term, by Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: 16 -55 Years ................................ ...
14.426. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
1 to 7 Day s After Dose 1 (as of Data Cutoff Date of 14NOV2020), by
System Organ Class and Preferred Term, by Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: >55 Years ................................ ......
14.427. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
2 to 7 Day s After Dose 2 (as of Data Cutoff Date of 14NOV2020), by
System Organ Class and Preferred Term, by Age Group Phase 2/3 (All
Subjects) Safet y Population Age Group: 16 -55 Years ................................ ...
14.428. Number (%) of Subjects Reporting at Least 1 Adverse Event From Dose
2 to 7 Day s After Dose 2 (as of Data Cutoff Date of 14NOV2020), by
System Organ Class and Preferred Term, by Age Gr oup Phase 2/3 (All
Subjects) Safet y Population Age Group: >55 Years ................................ ......
14.429. Number (%) of Subjects Reporting at Least 1 Related Adv erse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term ~38000 Subjects for Phase 2/3 Anal ysis Safety Population ..............
14.430. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Age Group: 16 -55 Years ................................ ................................ .
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CONFIDENTIAL14.431. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Age Group: >55 Years ................................ ................................ ....
14.432. Numbe r (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term Phase 2/3 (All Subjects) Safet y Population ................
14.433. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Phase 2/3 (All Subjec ts) Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.434. Number (%) of Subjects Reporting at Least 1 Related Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Phase 2/3 (All Subjects) Safety
Population Age Group: >55 Years ................................ ................................ ....
14.435. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 1, b y System Organ Class and Preferred Term ~38000 Subjects
for Phase 2/3 Anal ysis Safety Population ................................ ......................
14.436. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 2, b y System Organ Class and Preferred Term ~38000 Subjects
for Phase 2/3 Anal ysis Safety Population ................................ ......................
14.437. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 1, b y System Organ Class and Preferr ed Term Phase 2/3 (All
Subjects) Safet y Population ................................ ................................ ...........
14.438. Number (%) of Subjects Reporting at Least 1 I mmediate Adverse Event
After Dose 2, by System Organ Class and Preferred Term Phase 2/3 (All
Subjects) Safet y Population ................................ ................................ ...........
14.439. Number (%) of Subjects Report ing at Least 1 Severe Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term ~38000 Subjects for Phase 2/3 Anal ysis Safety Population ..............
14.440. Number (%) of Subjects Reporting at Least 1 L ife-Threatening Adverse
Event From Dose 1 to 1 Month After Dose 2, b y System Organ Class and
Preferred Term ~38000 Subjects for Phase 2/3 Analy sis Safety
Popul ation..........................................................................................................
14.441. Number (%) of Subjects Reporting at Least 1 Severe Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Cla ss and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.442. Number (%) of Subjects Reporting at Least 1 Severe Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Age Group: >55 Years ................................ ................................ ....
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CONFIDENTIAL14.443. Number (%) of Subjects Reporting at Least 1 L ife-Threatening Adverse
Event From Dose 1 to 1 Month After Dose 2, b y System Organ Class and
Preferred Ter m, by Age Group ~38000 Subjects for Phase 2/3 Anal ysis
Safety Population Age Group: 16- 55 Years ................................ ......................
14.444. Number (%) of Subjects Repo rting at Least 1 L ife-Threatening Adverse
Event From Dose 1 to 1 Month After Dose 2, b y System Organ Class and
Preferred Term, b y Age Group ~38000 Subjects for Phase 2/3 Anal ysis
Safety Population Age Group: >55 Years ................................ .........................
14.445. Number (%) of Subjects Reporting at Least 1 Severe Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term Phase 2/ 3 (All Subjects) Safet y Population ................
14.446. Number (%) of Subjects Reporting at Least 1 L ife-Threatening Adverse
Event From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ
Class and Preferred Term Phase 2/3 (All Subjects) Safet y Population .......
14.447. Number (% ) of Subjects Reporting at Least 1 Severe Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Phase 2/3 (All Subjects) Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.448. Number (%) of Subjects Reporting at Least 1 Severe Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Phase 2/3 (All Subjects) Safety
Population Age Group: >55 Years ................................ ................................ ....
14.449. Number (%) of Subjects Reporting at Least 1 L ife-Threatening Adverse
Event From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ
Class and Preferred Term, by Age Group Phase 2/3 (All Subjects) Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.450. Number (%) of Subjects Reporting at Least 1 L ife-Threatening Adverse
Event From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ
Class and Preferred Term, by Age Group Phase 2/3 (A ll Subjects) Safety
Population Age Group: >55 Years ................................ ................................ ....
14.451. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Do se 1 to 1 Month After Dose 2, by System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.452. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Popula tion Age Group: >55 Years ................................ ................................ ....
14.453. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2 , by System Organ Class and Preferred
Term, b y Baseline SARS -CoV -2 Status ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Baseline SARS -CoV -2 Status: Positive .............
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CONFIDENTIAL14.454. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Baseline SARS -CoV -2 Status ~38000 Subjects for Phase 2/3
Anal ysis Safet y Population Baseline SARS -CoV -2 Status: Negative ...........
14.455. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects
for Phase 2/3 Anal ysis Safety Population Baseline SARS -CoV -2 Status:
Positive Age Group: 16 -55 Years ................................ ................................ .....
14.456. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects
for Phase 2/3 Anal ysis Safety Population Baseline SARS -CoV -2 Status:
Positive Age Group: >55 Years ................................ ................................ ........
14.457. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects
for Phase 2/3 Anal ysis Safety Population Baseline SARS -CoV -2 Status:
Negative Age Group: 16 -55 Years ................................ ................................ ....
14.458. Number (%) of Subjects Reporti ng at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Baseline SARS -CoV -2 Status and Age Group ~38000 Subjects
for Phase 2/3 Anal ysis Safety Population Baseline SARS -CoV -2 Status:
Negative Age Group: >55 Years ................................ ................................ .......
14.459. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, by System Organ Class and Preferred
Term, b y Ethnicity ~38000 Subjects for Phase 2/3 Analy sis Safet y
Population Ethnicity : Hispanic/Latino ................................ ..............................
14.460. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Ethnicity ~38000 Subjects for Phase 2/3 Analy sis Safet y
Population Ethnicity : Non -Hispanic /Non -Latino ................................ ..............
14.461. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Or gan Class and Preferred
Term, b y Ethnicity ~38000 Subjects for Phase 2/3 Analy sis Safet y
Population Ethnicity : Not Reported ................................ ................................ ..
14.462. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Race ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Race: White ................................ ................................ .....................
14.463. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Race ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Race: Black or African American ................................ ...................
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CONFIDENTIAL14.464. Number (%) of Subjects Reporting at L east 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Race ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Race: All Others ................................ ................................ ..............
14.465. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Sex ~38000 Subjects for Phase 2/3 Analy sis Safety Population
Sex: Male ................................ ................................ ................................ ...........
14.466. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to 1 Month Afte r Dose 2, by System Organ Class and Preferred
Term, b y Sex ~38000 Subjects for Phase 2/3 Analy sis Safety Population
Sex: Female ................................ ................................ ................................ .......
14.467. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term ~38000 Subjects for Phase 2/3 Analy sis Safety
Population ................................ ................................ ................................ ..........
14.468. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Age Group: 16 -55 Years ................................ ....
14.469. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group ~38000 Subjects for Phase 2/3
Analy sis Safet y Population Age Group: >55 Years ................................ .......
14.470. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term Subjects With 2 Months Follow -Up Time After Dose
2 for Phase 2/3 Anal ysis Safety Population ................................ ...................
14.471. Number (%) of Subjects Reporting at Least 1 Serious Adve rse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Subjects With 2 Months Follow- Up
Time After Dose 2 for Phase 2/3 Anal ysis Safety Population Age Group:
16-55 Years ................................ ................................ ................................ .......
14.472. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Subjects With 2 Months Follow- Up
Time After Dose 2 for Phase 2/3 Anal ysis Safety Population Age
Group: >55 Years ................................ ................................ ..............................
14.473 . Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferred Term, b y Age Group Phase 2/3 (All Subjects) Safety
Population Age Group: 16 -55 Years ................................ ................................ .
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CONFIDENTIAL14.474. Number (%) of Subjects Reporting at Least 1 Serious Adverse Event
From Dose 1 to Data Cutoff Date (14NOV2020), by System Organ Class
and Preferre d Term, by Age Group Phase 2/3 (All Subjects) Safety
Population Age Group: >55 Years ....................................................................
14.475. Number (%) of Subjects Withdrawn Because of Adverse Events From
Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Analy sis Safety
Population Age Group: 16 -55 Years ................................ ................................ .
14.476. Number (%) of Subjects Withdrawn Because of Adverse Events From
Dose 1 to 1 Month After Dose 2, b y System Organ Class and Preferred
Term, b y Age Group ~38000 Subjects for Phase 2/3 Ana lysis Safety
Population Age Group: >55 Years ................................ ................................ ....
14.477. Number (%) of Subjects Withdrawn Because of Adverse Events From
Dose 1 to Data C utoff Date (14NOV2020), b y System Organ Class and
Preferred Term Phase 2/3 (All Subjects) Safet y Population .......................
14.478. Number (%) of S ubjects Withdrawn Because of Adverse Events From
Dose 1 to Data Cutoff Date (14NOV2020), b y System Organ Class and
Preferred Term, b y Age Group Phase 2/3 (All Subjects) Safet y
Population Age Group: 16 -55 Years ................................................................ .
14.479. Number (%) of Subjects Withdrawn Because of Adverse Events From
Dose 1 to Data Cutoff Date (14NOV2020), b y System Organ Class and
Preferred Term, b y Age Group Phase 2/ 3 (All Subjects) Safet y
Population Age Group: >55 Years ................................ ................................ ....
Supplemental Figures ................................ ................................ ................................ .........
14.1. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT90 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ ....
14.2. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT90 Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b 1
Evaluable Immunogenicity Population ................................ ................................ ....
14.3. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ ...
14.4. Reverse Cumulative Distribution Cu rves, SARS -CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ ....
14.5. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutralization Assay
NT90 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b1
Evaluable Immunogenicity Population ................................ ................................ ...
14.6. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutralization Assay
NT90 Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b1
Evaluable Immunogenicity Populatio n................................
....................................
14.7. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT90 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ ....
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CONFIDENTIAL14.8. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT90 Phas e 1, 2 Doses, 21 Day s Apart 65-
85 Years of Age BNT162b2
Evaluable Immunogenicity Population ....................................................................
14.9. Reverse Cumulative Distribution Curves, SARS -CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 18-
55 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ ....
14.10. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutralization Assay -
NT50 Phase 1, 2 Doses, 21 Day s Apart 65-85 Years of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ ....
14.11. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutralization Assay
NT90 Phase 1, 2 Doses, 21 Day s Apart 18-55 Years of Age BNT162b2
Evaluable Immunogenicity Popul ation ................................ ................................ ....
14.12. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutralization Assay
NT90 Phase 1, 2 Doses, 21 Day s Apart 65-85 Y ears of Age BNT162b2
Evaluable Immunogenicity Population ................................ ................................ ....
14.13. Reverse Cumulative Distribution Curves, RBD -Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age BNT162b1 Evaluable
Immunogenicit y Population ................................ ................................ .....................
14.14. Reverse Cumulative Distribution Curves, RBD -Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age BNT162b1 Evaluable
Immunogenicit y Population ................................
.....................................................
14.15. Reverse Cumulative Distribution Curves, S1- Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age BNT162b1 Evaluable
Immunogenicit y Population ................................ ................................ .....................
14.16. Reverse Cumulative Distribution Curves, S1- Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age BNT162b1 Evaluable
Immunogenicit y Population ................................ ................................ .....................
14.17. Reverse Cumulative Distribution Curves, RBD -Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age BNT162b2 Evaluable
Imm unogenicit y Population ................................
.....................................................
14.18. Reverse Cumulative Distribution Curves, RBD -Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 65-
85 Years of Age BNT162b2 Evaluable
Immunogenicit y Population ................................ ................................ .....................
14.19. Reverse Cumulative Distribution Curves, S1- Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 18-55 Years of Age BNT162b2 Evaluable
Immunogenicit y Population ................................ ................................ .....................
14.20. Reverse Cumulative Distribution Curves, S1 -Binding IgG Level Assay
Phase 1, 2 Doses, 21 Days Apart 65-85 Years of Age BNT162b2 Evaluable
Immunogenicit y Population ................................ ................................ .....................
14.21. Geometric Mean Titers and 95% CI: SARS- CoV -2 Neutralization Assay -
NT90 Phase 2 Dose 2 Evaluable Immunogenicity Population ..........................
14.22. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutraliation Assay
NT50 Phase 2 Dose 2 Evaluable Immunogenicity Population ..........................
14.23. Reverse Cumulative Distribution Curves, SARS- CoV -2 Neutraliation Assay
NT90 Phase 2 Dose 2 Evaluable Immunogenicity Population ..........................
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CONFIDENTIAL14.24. Reverse Cumulative Distribution Curves, S1- Binding IgG Level Assay
Phase 2 Dose 2 Evaluable I mmunogenicity Population .......................................
14.25. Subjects Reporting Local Reactions, by Maximum Severity , Within 7 Day s
After Each Dose Phase 2 Safet y Population ......................................................
14.26. Subjects Reporting S ystemic Events, b y Maximum Severity , Within 7 Day s
After Each Dose Phase 2 Safet y Population ......................................................
14.27. Cumulative I ncidence Curves for the First COVID -19 Occurrence From 7
Days After Dose 2 Subjects Without Evidence of Infection Prior to 7 Days
After Dose 2 Evaluable Efficacy (7 Day s) Population ................................ .........
14.28. Cumulative I ncidence Curves for the First COVID -19 Occurrence From 7
Days After Dose 2 Subjects With or Without Evidence of Infection Prior to 7
Days After Dose 2 Evaluable Ef ficacy (7 Day s) Population ................................
Subject Narratives...............................................................................................................
15.REFERENCES ................................................................................................................ 2033
ERRATA
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16. APPENDI CES
16.1. Study Information
16.1.1. Final Protocol and Protocol Amendments
16.1.2. Sample Case Report Form(s) (CRF)/Data Collection Tool(s) (DCT)
16.1.3. Independent Ethics Committees (I ECs) or Institutional Review
Boards (IRBs) and Sample Standard Subject Information Sheet and
Informed Consent Document (I CD)
16.1.4. List and Des cription of Investigators and Service Providers
16.1.5. Signatures of Principal or Coordinating/Leading Investigator(s) or
Sponsor's Responsible Medical Officer, Depending on the Regulatory
Authority 's Requirement
16.1.5.1. Sponsor and Sponsor Agent
16.1.5 .2. CSR I nvestigator Declaration
16.1.6. Listing of Subjects Receiving Investigational Product From
Specific Batches, Where More Than One Batch Was Used
16.1.7. Randomization Scheme and Codes (Subject I dentification and
Vaccine Assigned)
16.1.8 . Audit Cert ificates
16.1.9. Documentation of Statistical Methods
16.1.10. Documentation of Interlaboratory Standardization Methods (and
Quality Assurance Procedures if Used) (Refer to Module 5.3.1.4 for
immunoassay and RT -PCR methods)
16.1.11. Publications Based on t he Study
16.1.12. Important Publications Referenced in the Report (Available on
Request)
16.1.13. I ndependent Oversight Committees
16.2. Subject Data Listings
16.2.1. Discontinued Subjects
16.2.2. Protocol Deviations
16.2.3. Subjects Excluded From the Anal ysis
16.2.4. Demographic Data
16.2.5. Subject Compliance Data
16.2.6. Assay Data
16.2.7. Adverse Events by Subject
16.2.8. Individual Laboratory Measurements by Subject
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16.3. Case Report Form(s) (CRF) or Data Collection Tool(s) (DCT)
16.3.1. CRFs (or DCTs) For Deaths, Other Serious Adverse Events, and
Subject Withdrawals due to Adverse Events
16.3.2. Other CRFs (or DCTs)
16.4. Individual Subject Data Listings
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4. LIST OF ABBREVIATION S AND DEFINITION OF TERMS
Abbreviation Definition
AE adverse event
AESI adverse event of special interest
BDR blinded data review
BLQ below the level of quantitation
BMI body mass index
CDC Centers for Disease Control and Prevention (United States)
COVID -19 coronavirus disease 2019
CRF case report form
CRO contract research organization
CSR clinical study report
CV curriculum vitae
DCT data collection tool
DMC data monitoring committee
e-diary electronic diary
EU European Union
FIH first-in-human
FSFV first subject first visit
GCP Good Clinical Practice
GMC geometric mean concentration
GMFR geometric mean fold rise
GMR geometric mean ratio
GMT geometric mean titer
HBc Ab hepatitis B core antibod y
HBsAg hepatitis B surface antigen
HBV hepatitis B virus
HCS human convalescent ser um
HCV hepatitis C virus
HCV Ab hepatitis C virus antibody
HIV human immunodeficiency virus
IA interim analy sis
ICD informed consent document
ICH International Council for Harmonisation
ICU intensive care unit
IEC independent ethics committee
IgG immunoglobulin G
IgM immunoglobulin M
IND Investigational New Drug
IRB institutional review board
IRC internal review committee
IRR illness rate ratio
IRT interactive response technology
LLOQ lower limit of quantitation
LNP lipid nanoparticle
MedDRA Medical Dictionary for Regulatory Activities
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Abbreviation Definition
MERS Middle East respiratory syndrome
modRNA nucleoside -modified messenger ribonucleic acid
NAAT nucleic acid amplification test
N-binding SARS -CoV -2 nucleoprotein binding
NT50 neutralizing titer 50
NT90 neutralizing titer 90
NVA nonvaccine antigen
P2 S SARS -CoV -2 full -length, P2 mutant, prefusion spike gl ycoprotein
PD protocol deviation
Prevax prevaccination
PT preferred term
QA quality assurance
QTL quality tolerance limit
RBD receptor -binding domain
RCDC reverse cumulative distribution curve
RDC remote data capture
RNA ribonucleic acid
SAE serious adverse event
SAP statistical analy sis plan
SARS severe acute respiratory syndrome
SARS -CoV -2 severe acute respiratory syndrome coronavirus 2
SIRVA shoulder injury related to vaccine administration
SMQ standardized MedDRA queries
SOC system organ class
Tdap diphtheria vaccine toxoid; pertussis vaccine acellular 3
component; tetanus vaccine toxoid
TME targeted medical event
US United States
Vax vaccination
VE vaccine efficacy
WBC white blood cell count
WHO World Health Organization
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5.ETHICS
5.1. Independent Ethics Committee or Institutional Review Board
The final protocol, an y amendments ( Appendix 16.1.1), and ICD ( Appendix 16.1.3.2) were
reviewed and approved by the IRBs and/or
IECs for each of the investigational centers
participating in the stud y. The I RBs and IECs are listed in Appendix 16.1.3.1.
5.2.Ethical Conduct of the Study
This study was conducted in compliance with the ethical principles originating in or derived
from the Declaration of Helsinki and in compliance with all ICH GCP guidelines. In
addition, all local regulatory requirements were followed, in particular, those affording
greater protectio n to the safet y of trial participants.
5.3.Participant Information and Consent
In this clinical stud y report, the terms “participant” and “subject” are used interchangeabl y.
A signed and dated informed consent was required before an y stud y-specific activity was
performed. Informed consent was collected as detailed in the protocol. Refer to
Appendix 16.1.1, Protocol Section 10.1.2 for further information regarding informed consent.
6. INVESTIGATORS AND ST UDY ADMINISTRATIVE S TRUCTURE
The study was conducted by investigators contracted by and under the direction of Pfizer.
The investigators were responsible for adhering to the study procedures described in the
protocol, for keeping records of the study intervention, and for ensuring ac curate completion
of the CRFs and DCTs supplied by Pfizer.
Refer to Appendix 16.1.4 for a list of investigators and sites (including participants by
country ) and a list of service providers and external clinical testing laboratories involved in
this stud y. Refer to Appendix 16.1.10 for a list of internal and external clinical testing
laboratories involved in this study , with the tests that they performed.
No sites were terminated from the study to date.
7.INTRODUCTION
In December 2019, a pneumonia outbreak of unknown cause occurred in Wuhan, China.
InJanuary 2020, a novel coronavirus was discovered as the underly ing cause. Later in
January , the genetic sequence of the novel coronavirus became available to the WHO and
public (MN908947.3), and the virus wa s categorized as a Betacoronavirus . By sequence
analysis, the phy logenetic tree revealed a closer relationship to SARS coronavirus isolates
than to other coronaviruses that infect humans, including the MERS coronavirus.1,2
Infections b y the virus, named SARS -CoV -2, and the resulting disease, COVID -19, have
spread globall y.
On 11 March 2020, the WHO declared the COVID -19 o utbreak to be a pandemic.3 The
United States currently has the most reported cases globall y. At the time of this report, the 090177e195afe397\Approved\Approved On: 03-Dec-2020 16:12 (GMT)
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CONFIDENTIAL
number of confirmed cases exceeds 32 million globally and continues to rise.4 There are
currentl y no licensed vaccines to prev ent SARS -CoV -2 infections or COVID -19.5
An RNA -based prophy lactic COVID -19 vaccine is one of the most flexible and fastest
approaches available to potentially protect against the emerging virus.6,7
BioNTech has developed RNA vaccine platforms, including modRNA, with enhanced
intracellular stability and translation efficiency , blunted innate immune sensor activating
capacity and corres ponding increased antigen expression in the host cell. BioNTech has also
licensed an LNP delivery sy stem, with which the RNA is formulated. Each modRNA
candidate encodes either a P2 mutant S gly coprotein (P2 S) or the trimerized RBD of the
Sglycoprotein. Each candidate is given a V number that indicates t he specific version of the
optimized antigen coding sequence. Further details can be found in the investigator's
brochure .8 The candidates tested in this study were:
BNT162b1 (RBP020.3) modRNA encodi ng RBD (V5)
BNT162b2 (RBP020.2) modRNA encoding P2 S (V9).
BioNTech has been conducting a FIH, dose level –finding, Phase 1/2 study (BNT162 -01) in
German y to gather safet y and immunogenicit y data to evaluate multiple vaccine candidates,
This study isconducted under an approved German Clinical Trial Agreement and not under
the US IND .
In order to facilitate the interpretation of the immunogenicity data generated by the Phase 1
study , a human convalescent serum(HCS) panel was obtained from Sanguine Bi osciences
(Sherman Oaks, CA), the MT Group (Van Nu ys, CA), and Pfizer Occupational Health and
Wellness (Pearl River, NY). The 38 sera in the HCS were collected from SARS -CoV -2
infect ed or /COVID -19 positive individu als18 to 83 years of age at least 14 days after PCR -
confirmed diagnosis, and at a time when subjects were as ymptomatic . The serum donors
predominantly had sy mptomatic infections (35/38), and one had been hospitalized.9
Following evaluation of Phase 1 safet y and immunogenicity data for BNT162b1 and
BNT1 62b2 administered at different dose levels to adults in 2 age groups (18 to 55 y ears of
age and 65 to 85 years of age), Phase 2/3 evaluation commenced for this study on
27July 2020 using BNT162b2 at the 30 µg dose level in adult individuals.
This study isongoing, and participants are continuing to be enrolled and evaluated in Phase 3
at the time of this CSR . Efficacy data are presented at the data cutoff dates for the interim
and final anal ysis of efficacy . Demographic , disposition and safety data are p resented as
2cohorts . The first cohort includes 37,706 (N~38,000) participants who have a median
follow -up time of 2 months after the second dose. Safety data arealsopresented separatel y
for a subset of this cohort of 19,067 (N~19,000) participants who have 2 months or more of
safet y follow-up. The second cohort comprises all participants enrolled in the study as of a
data cutoff date (N~44,000) . The latter cohort is intended to provide a comprehensive
evaluation of safety as of the cutoff date, but the follow -up time will not be uniform across
all participants . This interim CSR summarizes:090177e195afe397\Approved\Approved On: 03-Dec-2020 16:12 (GMT)
Page 58
FDA-CBER-2021-5683-0780629
Interim Clinical Study Report
Protocol C4591001
CONFIDENTIAL
Phase 1 results of safet y and immunogenicit y for BNT162b1 and BNT162b2 in the
candidate -and dose level -finding part of the stud y for each dose l evel, age group, and
vaccine group (data cutoff date 24 August 2020) and long -term safet y follow -up
(approximately 4months after Dose 2 [as of cutoff date 14 November 2020]) for
BNT162b2 30 -µg.
Phase 2 primary safet y analyses (7 day s after Dose 2) for the first 360 participants
(180 randomized to active vaccine BNT162b2 and 180 to placebo, and stratified
approximately equall y between 18 to55years and >55 to 85 years) dosed at the
commencement of the Phase 2/3 part of the stud y (data cutoff date 02 Septe mber 2020)
and long -term safet y follow- up (includes at least 2 months of follow -up after Dose 2 [as
of the cutoff date of 14 November 2020]) .
Phase 2 exploratory immunogenicity anal yses for the first 360 participants 1 month after
Dose 2 (data cutoff date 12 October 2020)
Phase 2/3 primary safety anal ysis (1 month afte
…[truncated]

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