Document text
Pfizer -BioNTech COVID -19 Vaccine
C4591008 NON -INTERVENTIONAL INTERIM REPORT
22June 2021
PFIZER CONFIDENTIALNON- INTERVENTIONAL ( NI) INTERIM STUDY REPORT
Study Information
Title HERO-Together: A Post-Emergency Use
Authorization Observational C ohort S tudy to
Evaluate the S afety of the Pfizer -BioNTech
COVID -19 Vaccine in US Healthcare
Workers , Their Families, and Their
Communities
Protocol number C4591008
Version identifier of the interim study
reportv. 1.0
Date 22June 2021
EU Post Authorization Study (PAS)
register numberEUPAS38671
Active substance N/A
Medicinal product COVID -19 Vaccine
BNT162b2
Research question and objectives The research questions addressed b y this
study are:a) what are the incidence rates of
safet y events of interest and other clinicall y
significant events among persons vaccinated
with the Pfizer -BioNTech COVID -19
vaccine in a cohort of US healthcare
workers, their families, and their
communities andb) how do those rates
compare to expected rates of those events?
Primary study objectives:
Estimate the real- world incidence of
safet y events of interest and other
clinically significant events among
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PFIZER CONFIDENTIALUS healthcare workers , their
families, and their communities
+who are vaccinated with the Pfizer -
BioNTech COVID -19 vaccine
following Emergency Use
Authorization.
Secondary objective s
Evaluate whether the vaccine
recipients experience increased the
risk of safet y events of interest and
other clinicall y significant events
post-vaccination.
Estimate the incidence rates of safet y
events of interest and other clinicall y
significant events among subcohorts
of interest such as individuals who
are pregnant, individuals who are
immunocompromised, and stratified
by age.
Author Emily O’Brien, PhD
Duke Clinical Research Institute
200 Mor ris Street
Durham, NC 27701
This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, by
accepting or reviewing this document, you agree to hold this information in confidence and not copy or disclose it to
others (except where required by applicable law) or use it for unauthorized purposes. In the event of any actual or
suspected breach of this obligation, Pfizer must be promptly notified.
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PFIZER CONFIDENTIALTABLE OF CONTENTS
1. ABSTRACT (STAND -ALONE DOCUMENT) ................................ ...............................
2. LIST OF ABBREVIATIONS ................................ ................................ ............................
3. INVESTIGATORS ................................ ................................ ................................ ............
4. OTHER RESPONSI BLE PARTIES ................................ ................................ ..................
5. MILESTONES ................................ ................................ ................................ ...................
6. RATIONALE AND BACKGROUND ................................ ................................ ..............
7. RESEARCH QUESTION AND OBJECTI VES ................................ ...............................
8. AMENDMENTS AND UPDATES ................................ ................................ ...................
9. RESEARCH METHODS ................................ ................................ ................................ ..
9.1. Study design ................................ ................................ ................................ ................
9.2. Setting ................................ ................................ ................................ ..........................
9.3. Subjects................................ ................................ ................................ ........................
9.3.1. I nclusion Criteria ................................ ................................ ................................ ...
9.3.2. Exclusion Criteria ................................ ................................ ................................ ..
9.3.3. R ecruitment ................................ ................................ ................................ ...........
9.3.4. Enrollment................................ ................................ ................................ .............
9.3.5. Retention ................................ ................................ ................................ ...............
9.3.6. Participant Follow -up and Data Collection ................................ ...........................
9.4. Variables ................................ ................................ ................................ ......................
9.4.1. Safet y events of interest ................................ ................................ ........................
9.5. Data sources and measurement ................................ ................................ ....................
9.5.1. Participant report ................................ ................................ ................................ ...
9.5.2. Call Center Data Collection ................................ ................................ ..................
9.5.3. Clinical Events Ascertainment (CEA) ................................ ................................ ..
9.6. Bias ................................ ................................ ................................ ..............................
9.7. Study Size ................................ ................................ ................................ ....................
9.8. Data transformation ................................ ................................ ................................ .....
9.9. Statistical methods ................................ ................................ ................................ .......
9.9.1. Main summary measures ................................ ................................ .......................
9.9.2. Main statistical methods................................ ................................ ........................
9.9.3. Missing values ................................ ................................ ................................ .......
9.9.4. Sensitivity analy ses................................ ................................ ...............................
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PFIZER CONFIDENTIAL9.9.5. Amendments to the statistical anal ysis plan ................................ ..........................
9.10. Quality control ................................ ................................ ................................ ...........
9.11. Protection of human subjects................................ ................................ .....................
10. RESUL TS................................ ................................ ................................ ........................
10.1. Participants ................................ ................................ ................................ ................
10.2. Descriptive data ................................ ................................ ................................ .........
10.3. Main results ................................ ................................ ................................ ...............
10.4. Other analy ses................................ ................................ ................................ ...........
10.5. Safet y events / adverse reactions...............................................................................
11. DI SCUSSION ................................ ................................ ................................ ..................
11.1. Key results ................................ ................................ ................................ .................
11.2. L imitations ................................ ................................ ................................ .................
11.3. I nterpretation ................................ ................................ ................................ .............
11.4. Generalizability ................................ ................................ ................................ .........
12. OTHER INFORMATION ................................ ................................ ...............................
13. CONCL USIONS ................................ ................................ ................................ ..............
14. REFERENCES ................................ ................................ ................................ ................
LIST OF TABLES
Table 1. Amendments to the Protocol ................................ ................................ ..................
Table 2. HERO Registry Participants (Preliminary Data) as of December 2020 ................
Table 3. Demographic Composition of the HERO Registry (Preliminary Data) as of
December 2020 ................................ ................................ ................................ ..............
Table 4. Schedule of Assessments................................ ................................ ........................
Table 5. Description of Final Event Classifications................................ .............................
Table 6. Estimated Precision of Observed Event Rates* ................................ .....................
Table 7. Completion rates for anal ysis populations ................................ .............................
LIST OF FIGURES
Figure 1. Participant Jou rney................................ ................................ ................................
Figure 2. Confirmation of Safet y Events of Interest During Follow -up ..............................
Figure 3. CONSORT Diagram ................................ ................................ .............................
Figure 4. Distribution of Age in the PASP and CNP ASP ................................ ....................
Figure 5. Baseline Demographics of the PASP and CNPASP ................................ .............
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PFIZER CONFIDENTIALFigure 6. Counts of Participants who had Adverse Events of Special Interest in the
PASP ................................ ................................ ................................ .............................
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PFIZER CONFIDENTIAL15. LIST OF SOURCE TABLES AND FIGURES................................ ...............................
Table 15.5.1 -Disposition and Retention ................................ ................................ ...........
Figure 15.5.1.1 - Cumulative Rate of Study Discontinuation All Consented
Population ................................ ................................ ................................ ....................
Figure 15.5.1.2 - Cumulative Rate of Study Discontinuation Primary Analy sis Safet y
Population ................................ ................................ ................................ ....................
Table 15.5.2 -Visit Co mpletion ................................ ................................ .........................
Table 15.1.1 -Baseline Demographics ................................ ................................ ...............
Table 15.1.2.1 -Baseline Medical History (Participant Reported) ................................ ....
Table 15.1.2.2 -Baseline Medical Hist ory Stratified by Pfizer vs Non- Pfizer Vaccine
(Participant Reported) and by Enrolment Within 10 Day s ................................ .........
Table 15.1.3 -Baseline Medicatio ns ................................ ................................ ..................
Table 15.1.4 -Baseline Pregnancy / Baseline Vaccine History ................................ .........
Table 15.3.1.1 -Participant Reported Unplanned Hospitalization Anytime After Receipt
of at Least 1 Dose of COVID -19 Vaccine ................................ ................................ ..
Table 15.3.1.2 -Participant Reported Unplanned Hospitalization Anytime After Receipt
of at Least 1 Dose of COVID -19 Vaccine by Baseline Vaccine Ty pe -Pfizer -All
Consented Population ................................ ................................ ................................ ..
Table 15.3.1.3 -Participant Reported Unplanned Hospitalization Anytime After Receipt
of at Least 1 Dose of COVID -19 Vaccine by Baseline Vaccine Ty pe -Other
COVID -19 Vaccine - All Consented Population ................................ ........................
Table 15.3.1.4 -Participant Reported Unplanned Hospitalization Anytime After Receipt
of at Least 1 Dose of COVID -19 Vaccine by Baseline Pregnancy -Primary
Analy sis Safet y Population ................................ ................................ .........................
Table 15.3.1.5 -Participant Reported Unplanned H ospitalization Any time After Receipt
of at Least 1 Dose of COVID -19 Vaccine by Baseline Age Group -Primary
Analy sis Safet y Population ................................ ................................ .........................
Table 15.3.1.6 -Participant Reported Unplanned Hospitalization Anytime After Receipt
of at Least 1 Dose of COVID -19 Vaccine by Baseline I mmunocompromised Status
-Primary Anal ysis Safety Population ................................ ................................ .........
Table 15.3.1.7 -Participant Reported Unplanned Hospitalization Anytime After Receipt
of at Least 1 Dose of Pfizer COVID -19 Vaccine by Dose Status -Primary Analy sis
Safety Population ................................ ................................ ................................ ........
Table 15.3.2.1.1 -Participants Reported Adverse Events of Special Interest Any time
After Receipt of at Least 1 Dose of COVID -19 Vaccine ................................ ............
Table 15.3.2.1.2 -Participants Reported Adverse Events of Special Interest Any time
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline Vaccine Ty pe
-Pfizer - All Consented Population ................................ ................................ ............
Table 15.3.2.1.3 -Participants Reported Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline Vaccine Ty pe
-Other COVID -19 Vaccine -All Consented Population ................................ ............
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PFIZER CONFIDENTIALTable 15.3.2.1.4 -Participants Reported Adverse Events of Special Interest Any time
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline Pregnancy -
Primary Anal ysis Safet y Population ................................ ................................ ............
Table 15.3.2.1.5 -Participants Reported Adverse Events of Special Interest Any time
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Age Group -Primary
Analy sis Safet y Population ................................ ................................ .........................
Table 15.3.2.1.6 -Participants Reported Adverse Events of Special Interest Any time
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Immunocompromised Individuals - Primary Analy sis Safet y Population ..................
Table 15.3.2.1.7 -Participants Reported Adverse Events of Sp ecial Interest Any time
After Receipt of at Least 1 Dose of Pfizer COVID -19 Vaccine b y Dose Status -
Primary Anal ysis Safet y Population ................................ ................................ ............
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22June 2021
PFIZER CONFIDENTIALAnnex 1. List of stand -alone documents
Appendix 1. SIGNATURES
Appendix 2. PROTOCOL
Appendix 3. I NVESTIGATORS AND CORRESPONDI NG INDEPENDENT
ETHI CS COMMITTEES (I ECs) OR INSTITUTIONAL REVIEW BOARDS (I RBs)
Refer to section 3 I nvestigators and section 5 Milestones.
Appendix 4. STATI STICAL ANALYSI S PL AN
Appendix 5. SAMPLE CASE REPORT FORM (CRF) / DATA COLLECTION TOOL
(DCT))
Not applicable
Appendix 6. SAMPLE STANDARD SUBJECT I NFORMATION SHEET AND
INFORMED CONSENT DOCUM ENT (I CD)
Appendix 7. LIST OF SUBJECT DATA LI STINGS
Listing 7.7.1Withdrawn Subjects
Listing 7.7.2 Protocol Deviations
Listing 7.7.3 Subjects Excluded from the Anal ysis
Listing 7.7.4Demographic Data
Listing 7.7.5Medication/Treatment Data
Listing 7.7.6 Participant Reported Unplanned Hospitalization
Listing 7.7.7 Participant Reported Non -Hospitaliz ation Safety Events of Interest
Appendix 8. ADDI TIONAL DOCUMENTS
Not applicable
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PFIZER CONFIDENTIAL1.ABSTRACT (STAND -ALONE DOCUME NT)
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PFIZER CONFIDENTIAL2. LIST OF ABBREVIATIONS
Abbreviation Definition
ACP All Consented Population
ADaM Analy sis Data Model
AESI Adverse Event of Special Interest
CEA Clinical Events Ascertainment
CNPASP Consented but Not in the Primary Anal ysis Safet y
Population
DCRI Duke Clinical Research Institute
EUA Emergency Use Authorization
GEP Good Epidemiological Practice
GPP Good Pharmacoepidemiology Practices
HCW Health care worker
HERO Healthcare Worker Exposure Response and
Outcomes
ICF Informed Consent Form
IEA International Epidemiological Association
IEC Independent Ethics Committee
IRB Institutional Review Board
PASS Post-Authorization Safety Study
PASP Primary Anal ysis Safet y Population
SAP Statistical analy sis plan
SDTM Study Data Tabulation Model
SOP Standard operating procedure
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PFIZER CONFIDENTIAL3. INVESTIGATORS
Principal Investigator (s)of the Protocol
Name, degree(s) Job Title Affiliation Address
Emily O’Brien, PhD Epidemiologist Duke Clinical Research
Institute200 Morris Street
Durham, NC 27701
Adrian Hernandez,
MD, MHSExecutive Director Duke Clinical Research
Institute200 Morris Street
Durham, NC 27701
Heather Rubino,
PhD, MSDirector , Global
Medical
EpidemiologyPfizer Inc. 235 E 42ndSt,
New York, NY 10017
Ann Madsen, PhD Director, G lobal
Medical
EpidemiologyPfizer Inc. 235 E 42ndSt,
New York, NY 10017
4.OTHER RESPONSIBLE PA RTIES
Not applicable.
5.MILESTONES
Milestone Planned date Actual date Comments
Start of data collection 17 December 2020 17 December 2020
End of data collection 30 June 2023
Registration in the EU PAS
registerPrior to start of data
collection,
December 2020
Interim Reports 30 June 2021
31 December 2021
30 June 2022
31 December 202222June 2021
Final report of study results 31 December 2023
6.RATIONALE AND BACKGR OUND
In the US, Pfizer -BioNTech COVID -19 vaccine was approved for emergency use
authorization (EUA) to prevent Coronavirus Disease 2019 (COVID- 19) for individuals 16
years of age and older on December 11, 2020. Detailed distribution plans for the COVID-19
vaccine within the US are currently determined by local jurisdictions based on federal
recommendations to prioritize vaccination of healthcare workers and people living in long
term care facilities under an EUA. This study is designed to provide earl y real-world safet y
information on a c ohort of vaccinated healthcare workers, their families, and their
communities for two years after vaccination.
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PFIZER CONFIDENTIALThis non- interventional study was designated as a Post -Authorization Safety Study (PASS)
and wa s commit ted to the FDA in the US PVP .
7.RESEARCH Q UESTION AND OBJECTIV ES
The research questions addressed b y this study are :a) what are the incidence rates of adverse
safet y events of interest and other clinicall y significant events among persons vaccinated
with the Pfizer -BioNTech COVID -19 vaccine in a cohort of US healthcare workers, their
families, and their communities and b) how do those rates compare to expected rates of those
events?
Primary study objectives:
Estimate the real- world incidence of safety events of interest and other clinically
significant events among US healthcare workers, their families, and their
communities who are vaccinated with the Pfizer- BioNTech COVID -19 vaccine
following Emergency Use A uthorization.
Secondary objective s
Evaluate whether vaccine recipients experience increased risk of safet y events of
interest and other clinically significant events post -vaccination.
Estimate the incidence rates of safet y events of interest and other clin ically significant
events among subcohorts of interest such as individuals who are pregnant, individuals
who are immunocompromised, and stratified b y age.
8.AMENDMENTS AND UPDAT ES
Table 1.Amendments to the Protocol
Amendment
numberDate Protocol section(s)
changed Summary of
amendment(s)Reason
1 22
January
2021Title page
Abstract
Milestones
Rationale and
BackgroundAdded field for EU PAS
registration number on
title page.
Removed interim report
on 31 March 2021.
Removed designation as
Category 3 post -
authorization safety study
in EU risk management
plan (RMP) and noted
study is included in the
US PVP.EU PAS registration number
was inadvertently left out.
Data from the first quarter of
2021 are limited. US
vaccinations p rogram not
fully deployed until January
Study was not included in
final RMP
2 20 April
2021Title page
Abstract
Research question and
objectives
Research methodsExpanded population to
include HCW families
and community members Revisions in response to FDA
protocol review comments
Expanded population
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PFIZER CONFIDENTIALTable 1.Amendments to the Protocol
Amendment
numberDate Protocol section(s)
changed Summary of
amendment(s)Reason
Inclusion criteria
Participant follow -up
Clinical events
ascertainment
Data analysisAdded Project Baseline
Community Study to
recruitment sources
Updated subgroups
Additional detail about
CEA Committee process
and event confirmation
Additional recruitment
strategies
Removed medical release
requirement for
enrollmentRecruitment pathway through
Project Baseline Community
Study added
Event confirmation step
added
Removal of medical release
require ment from inclusion
criteria only
Editorial changes
9.RESEARCH METHODS
9.1.Study design
This study is a prospective observational stud y designed to evaluate the incidence rates of
safet y events of interest and other clinicall y significant events within a coh ort of healthcare
workers, their families, and their communities who receive the Pfizer -BioNTech COVID -19
vaccine under the EUA program in the United States. The study is a primary data collection
study with review of medical records. Receipt of the vaccin e is required for inclusion in the
study , but the decision to be vaccinated is made at the discretion of the recipient.
As described in the protocol ( see Appendix 2), t his study will enroll and follow 20,000
vaccinated healthcare workers, their families, and their communities during a 30- month study
period. Information on hospitalization and diagnosis of safet y events of interest are collected
from participant report at regular intervals following vaccination, primarily using a secure ,
participant -facing web portal. Participant reports of safet y events of interest and/or
hospitalization trigger a request for and review of participant medical record information for
confirmation and adjudication of the event (see Figure 1 for additional details). To address
the primary objective, incidence rates of safet y events will be estimated based on cases that
are positivel yadjudicat ed.To address the secondary objective regarding assessment of
increased risk, a self -matched comparative anal ysis will be undertaken for feasible safety
events (e.g., events with a known risk interval and sufficient case counts). Additional context
for the r ates observed in vaccinated individuals will be sought from population background
rates and/or unvaccinated person years in the HERO Registry.
As no participant reported events had completed adjudication as of April 29, 2021, this
interim report 1 descrip tively summarizes self -reported hospitalizations and safet y events of
interest that have been confirmed. Future interim reports will summarize the comparative
analyses performed on fully adjudicated events.
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PFIZER CONFIDENTIAL9.2. Setting
In this stud y, there are no treating -healthcare providers serving as investigators that oversee
the recruitment, enrollment, or data collection for study participants. Rather, participants self-
enroll via a secure ,participant- facing web portal, either at the vaccination site or remotel y.
While participants may enroll from any where in the US, the study is actively promoted
through three main settings. The firstsetting is the Healthcare Worker Exposure Response
and Outcomes (HERO) Registry Study , launched in April 2020 to characterize COVID -19
risk factors and outcomes among healthcare workers (HCWs) in the United States by the
Duke Clinical Research Institute (DCRI ).In April 2021, due to HERO Registry members
consistently identify ing the family unit as an important focus area for research and as vaccine
supply has grown sufficient to make vaccine more widel y available outside of limited
occupational and age groups, the HERO Registry was expanded to include HCW families
and community members (defined as the group of people that live, work, or interact with
healthcare workers in their households, or an yone in the community ). The overall goal of the
HERO Registry is to create and engage a community of healthcare workers, their families,
and thei r communities, who may be eligible for participation in future research studies,
including studies of COVID -19 proph ylaxis and treatment. The HERO registry currentl y
comprises over 30 ,000 participants in all 50 states and is recruiting new participants for
inclusion on an ongoing basis. Due to the broad population definition and limited
inclusion/exclusion criteria, the registry supports enrollment of a diverse population and
greater generalizability of results. The population for this first interim report includes only
healthcare worker participants who enrolled prior to study expansion ( 30 April 2021).
Existing HERO Registry participants aresent notifications of the opportunity for healthcare
workers, their families, and community members to participate i n a stud y of long -term
outcomes after vaccination .
The demographic characteristics of the HERO Registry as of December 2020 are described
inTable 2 and Table 3.
Table 2.HERO Registry Participants (Preliminary Data) as of December 2020
Total HERO Registry
Participants (n=15,629)Frequency Percent Cumulative
FrequencyCumulative
Percent
Physician 3265 20.89 3265 20.89
Nurse (RN/LPN) 5202 33.28 8467 54.17
Param edic/Emergency Medical
Technician463 2.96 8930 57.14
Other (free text) 2442 15.62 11372 72.76
Physician's assistant/Nurse
practitioner (PA/NP)1226 7.84 12598 80.61
Other Health Diagnosing and
Treating Practitioners1321 8.45 13919 89.06
Health technologists,
technicians, and clinical
support staff 343 2.19 14262 91.25
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PFIZER CONFIDENTIALTable 2.HERO Registry Participants (Preliminary Data) as of December 2020
Total HERO Registry
Participants (n=15,629)Frequency Percent Cumulative
FrequencyCumulative
Percent
Healthcare support,
administrative, and research
staff 1367 8.75 15629 100.00
Frequency Missing = 220
Table 3.Demographic Composition of the HERO Registry (Preliminary Data) as of
December 2020
Gender
Male Fem ale OtheraTotal
Race White 2,973
(18.56%)10,507
(65.59%)41
(0.26%)13,521
(84.41%)
Black or African American 123
(0.77%)487
(3.04%)2
(0.01%)612
(3.82%)
American Indian or Alaska Native 7
(0.04%)33
(0.21%)1
(0.01%)41
(0.26%)
Asian 364
(2.27%)588
(3.67%)2
(0.01%)954
(5.96%)
Native Hawaiian or Other Pacific Islander 4
(0.02%)16
(0.10%)0
(0.00%)20
(0.12%)
Other 81
(0.51%)180
(1.12%)0
(0.00%)261
(1.63%)
Multi -race 72
(0.45%)237
(1.48%)2
(0.01%)311
(1.94%)
Not Available (Prefer not to answer) 94
(0.59%)184
(1.15%)21
(0.13%)299
(1.87%)
Ethnicity Yes, Hispanic (Latino/Latina) 303
(1.89%)961
(6.00%)4
(0.02%)1,268
(7.92%)
No, not of Hispanic, Latino, or Spanish origin 3,347
(20.89%)11,137
(69.52%)46
(0.29%)14,530
(90.70%)
Not Available (Prefer not to answer) 68
(0.42%)134
(0.84%)19
(0.12%)221
(1.38%)
Total 3,718
(23.21%)12,232
(76.36%)69
(0.43%)16,019
(100.00%)
a.Gender = Other include male-to-female , female -to-male , gender expansive/variant, gender not listed, and
prefer not to answer
The second setting is major health s ystems distributing Pfizer -BioNTech COVID- 19 vaccine
to its employ ees, their families, and community members as determined by local
jurisdictional EUA rollout plans. R ecruitment efforts focused on healthcare sy stems allocated
large number of Pfizer COVID- 19 vaccine doses, fea sibility of recruitment and geographic
diversity . Study navigators at some sites facilitate denrollment of vaccine recipients . At the
data lock point for this interim report, families and community members from this settin g
were not eligible for the study and therefore their data is not included in this report.
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PFIZER CONFIDENTIALA third setting for recruiting patients is the Project Baseline Community Study platform
launched in April 2019 by Verily Life Sciences to acquire, organize, anal yze, and activate
phenoty pic data for a group of participants over time. At the data lock point for t his interim
report, families and community members from this setting were not eligible for the study and
therefore their data is not included in this report .
9.3.Subjects
Subjects in HERO -Together include healthcare workers, their famil ies, or any one in the
surrounding community who is 18 y ears or older as of December 17, 2020 (date of stud y
launch) . The population for this first interim report includes only healthcare worker
participants who enrolled prior to study expansion ( 30 April 2021) reflecting initial inclusion
criteria for this study .
9.3.1. Inclusion Criteria
Participant s must be one of the following:
1. A healthcare worker (individual currentl y working in a setting where individuals
receive healthcare in the US including emergency medical services);
OR
2. Part of a famil yto which healthcare workers may also belong *
OR
3. Any one in the surrounding community *
Participant s must also be all of the following :
Age ≥18years.
Able to speak and read English or Spanish **.
Recei pt of the first d ose of a COVID -19 vaccine for prevention of SARS- CoV -2
infection within the past 60 day s.
Evidence of informed consent indicating that the participant (or a legall y acceptable
representative) has been informed of all pertinent aspects of the study .
* Recr uitment criteria added with 20 April 2021 protocol revision.
**Spanish language recruitment materials , study materials and Baseline Community Study
web portal were not available in Spanish during the reporting period for this interim report
(17 December 2020 to 29 April 2021 ).
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PFIZER CONFIDENTIAL9.3.2. Exclusion Criteria
There are no exclusion criteria for this study . All participants meeting inclusion criteria will
be eligible for anal ysis.
9.3.3. Recruitment
All methods for recruitment and retention are detailed in a separate recruitment and retention
workplan, which is continuously updated with ongoing and planned recruitment efforts.
Recognizing the limitations of an entirel y participant -driven study , there are several
strategies in place to ensure that recruitment goals are met, while minimizing missing and
inaccurate data, and loss to follow-up.
A potential participant may learn about the opportunity to receive a COVID -19vaccine
through a variet y of mechanisms that may include their employ eror by email sent to existing
HERO Registry or Project Baseline Community Study members. Recruitment materials may
also be present in the vaccine administration area.
In addition to registry and health sy stem -based recru itment, promotion efforts leverage public
communication, social media and other advertising, and printed enrollment materials with
information about the study at vaccination sites. These efforts include 5 primary strategies: 1)
Digital promotion through on line advertising; 2) Partnerships with local health organizations
(for example, NC Department of Health and Human Services) and professional societies (for
example, the American Society for Clinical Oncology and the American Association for
Respiratory Care) for dissemination of information 3) Grand rounds/educational
presentations to institutional audiences provided by HERO -Together investigators; 4) Social
media influencer partnerships; and 5) Participant- driven outreach including tag -a-friend
campaigns a nd “Why I joined” videos on the study website. Each of these strategies are
anticipated to broaden our reach bey ond major health sy stems and facilitate connection with
healthcare workers, and members of their families and communities who may have had later
access to vaccines. Additionally , given that the primary anal ysis will include recipients of the
Pfizer -BioNTech vaccine, digital promotion efforts target the geographic regions represented
in current Pfizer -BioNTech vaccine distribution plans. Participan t enrollment through these
channels is activel y tracked and recruitment plans will be revised to reflect the highest -yield
strategies.
All recruitment materials focus on enrollment into a research stud y on vaccine safet y and
avoid language promoting the Pf izer-BioNTech COVID- 19 vaccine itself.
Diversity -Focused Recruitment
The study team is currently implementing 3 strategies focused on enhancing diversit y in
HERO-Together specificall y. These include 1) an extended recruitment plan with broad
strategies to reach healthcare workers , their families and their communities who may not be
connected to major healthcare s ystems, including those who work in long -term care facilities;
2) culturall y sensitive electronic and printed recruitment materials to ensure that imagery
reflects a diverse population with respect to race/ethnicity and professional role; and 3)
customized recruitment materials for specific professional roles (for example, long-term care
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PFIZER CONFIDENTIALfacility staff, dental health providers , and first responders ). The demographic and
professional role distributions of enrolled participants arecontinually monitored and
diversity -focused recruitment strategies will be refined accordingl y.
BRecruitment of HCWs, and their families and communities not participating in the HERO
Registry occur via public communication, social media and other advertising, and printed
enrollment materials with information about the study at vaccination sites.
9.3.4. Enro llment
Participants may enroll at the vaccination s ite or may self-enroll remotel y.At select
vaccination sites, study navigators are available to assist with recruitment and enrollment
after individuals are vaccinated. Virtual study navigators may also as sist with enrollment via
phone and/or text. Study navigators may assist with entry of vaccine -related information
(date, manufacturer, lot #) in the web portal to ensure accuracy . Based on conversations with
many institutions affiliated with the HERO Regi stry, optimal navigator workflow is
determined depending on institutional plans for vaccination. For example, at some
institutions, the navigator willinteract with the potential participant shortl y before receiving
the vaccine (e .g., at the time of regis tration, or at check -in to the vaccine administration area),
while others may interact with potential participants in the recovery area where recipients
will spend time after the vaccine.
As shown in Figure 1, existing members of the HERO Registry and the Project Baseline
Community Study are instructed to complete a screening questionnaire and an informed
consent form (I CF), at which point they are enrolled in the study . Non-members are enrolled
in the HERO Registry or in the Project Baseline Community Study Community and then
directed to complete the screening questionnaire and informed consent form. I n addition,
proxy contact information is collected at enrollment to sup port data capture in the event that
the participant cannot be reached (e.g., participant is hospitalized).
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PFIZER CONFIDENTIAL
Figure 1.Participant Journey
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PFIZER CONFIDENTIAL9.3.5. Retention
As part of the HERO Registry , participant engagement is sought by a series of community
building activities and modules that are informed by the participant’s “voice.” Prior to the
launch of HERO -Together, HERO Registry participants have demonstrated high
responsiveness. As described below, “rescue” strategies to prompt survey completion have
resulted in substantially improved completion.
Additionally , there is an automated sy stem built into the Verily web portal that notifies the
DCRI Call C enter when a participant has not completed a survey . The DCRI Call Center,
with their staff of bilingual interviewers (Spanish and English), operates 7 day s a week,
offers toll -free lines for participant use, and includes time zone accommodations.
Interviewers undergo extensive orientation , ethics training, and are taught standardized
interviewing techniques. The DCRI Call Center provides follow -up support to participants
who do not complete their digital survey s -this process is known as “rescue” . In addition, the
Call Center is available to answer questions about the study prior to and during enrollment.
The role of the DCRI Call Center is to rescue survey s that are not completed, or are missing
key components, by contacting participants, using contact information pr ovided by the
participant at baseline. Participants are offered preferred times to call and a toll -free line to
use at their convenience.
9.3.6. Participant Follow -up and Data Collection
Participants are followed from date of enrollment until the end of the 24 -month period
following first vaccine dose, end of the stud y period, death, loss- to-follow up (no response
after a notable interval of attempted Call Center contacts), or withdrawal from study .
Following enrollment, all participants enter data into a secure, participant -facing web portal
at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6-, 9 -, 12- 18- , and 24 -months
following receipt of the first dose of the vaccine. Second dose information is solicited during
follow up. Participants are queried regarding their general health and events requiring
medical attention. Participants who do not complete data entry within a notable period of
time of the expected completion date for a given time point are contacted by the Call Center
for an update on health status. Participants who report a clinicall y important medical event
(e.g., non- routine visit to medical provider or hospitalization) are prompted to complete a
medical record release form in the web portal, which is used to collect medical records for
review b y the Clinical Event Ascertainment group for confirmation of the occurrence of a
safet y event of interest. For an y participant who reports a potential safet y event of interest ,
medical records during the y ear prior to vaccination may also be r eviewed to support a self -
matched comparative analy sis.Only descriptive analy ses are presented in this report. Self -
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PFIZER CONFIDENTIALmatched comparative results will be presented in future reports, after participant reported
events have been full y adjudicated.
9.4.Variables
Variable Role Data Source(s)
Date of 1stdose COVID- 19 vaccination Exposure Participant
Site where 1stdose COVID -19 vaccine was
administeredExposure Participant
COVID -19 vaccine lot number (1stdose) Exposure Participant
Date of 2nddose COVID- 19 vaccination Exposure Participant
Site where 2nddose COVID -19 vaccine was
administeredExposure Participant
COVID -19 vaccine lot number (2nddose) Exposure Participant
Pregnancy Information (pregnancy status
and estimated due date)Outcome (utilization
analyses) and covariate
(safety analyses)Participant
Dem ographics Outcome ( utilization
analyses) and covariate
(safety analyses)Participant
Medical History Outcome ( utilization
analyses) and covariate
(safety analyses)Participant
Employment characteristics of the
participantOutcome (utilization
analyses) and covariate
(safety analyses)Participant
Vaccination details Exposure variable Participant
Concomitant medications Outcome (utilization
analyses) and covariate
(safety analyses)Participant
Participant -reported outcomes Outcome Participant
Safety events of interest ( Section 9.4.1 ) Outcome Particip ant, proxy, or medical
record/insurance claims review
COVID -19 Diagnosis Outcome Participant, proxy, or medical
record/insurance claims review
Hospitalizations Outcome Participant, proxy, or medical
record/insurance claims review
Death Outcome Proxy, or medical
record/insurance claims review
9.4.1. Safety events of interest
For this first interim report, all participant -reported safet y events are awaiting full clinical
adjudication and should be treated as preliminary . The safet y events of interest in this s tudy
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PFIZER CONFIDENTIALare based on the Priorit y List of Adverse Events of Special Interest from the Brighton
Collaboration’s Safet y Platform for Emergency vACcines (SPEAC) Project1and CDC
enhanced safety monitoring recommendations2). The safet y events of interest in this study
include:
Neurologic:
Generalized convulsion/seizures
Guillain -Barre S yndrome
Aseptic meningitis
Encephalitis/encephalomyelitis
Other acute dem yelinating diseases
Transverse m yelitis
Multiple sclerosis
Optic neuritis
Bell’s pals y
Immunologic :
Anaph ylaxis
Vasculitides*
Arthritis/arthralgia
Multisy stem inflammatory syndrome (in adults)
Kawasaki disease
Fibrom yalgia
Autoimmune thy roiditis
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PFIZER CONFIDENTIALCOVID -19:
Severe COVID -19 disease*
Microangiopat hy*
Heart failure and cardiogenic shock*
Stress cardiom yopath y*
Coronary artery disease*
Arrh ythmia *
Deep vein thrombosis
Pulmonary embolus
Cerebrovascular stroke
Limb ischemia*
Hemorrhagic disease*
Acute kidney injury *
Liver injury
Chilblain -like lesions
Single organ cutaneous vasculitis*
Erythema multiforme*
Cardiac:
Myocarditis
Pericarditis
Acute m yocardial infarction
Hematologic:
Thrombocy topenia
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PFIZER CONFIDENTIALDisseminated intravascular coagulation
Other:
Pregnancy outcomes
Death
Narcoleps y and cataplexy ;
Non-anaph ylactic allergic reactions
*Hospitalized manifestations only
9.5.Data sources and measurement
Data arecaptured through several mechanisms, described below. All data collected in the
context of this study arestored and evaluated per applicable regulatory requ irements and
guidance for electronic records. Data arestored and evaluated in a manner that protects
participant confidentiality in accordance with the legal stipulations apply ing to
confidentiality of data.
9.5.1. Participant report
Participants provide informa tion on COVI D-19 vaccination, baseline characteristics, seeking
of non-routine medical care (including hospitalization) and potential occurrence of safet y
events of interest. Following enrollment, the participant enters data into a secure ,participant
facing web -portal . Data entry occurs according to the schedule of assessments described in
Table 4. Participants who miss assessments during follow-up, and individuals with longer
than a 2- day interval between vaccination and enrollment are administered a retrospective
assessment to capture participant- reported safet y information occurring within this interval.
If an assessment is incomplete after a notable period of time, the participant will be contacted
by the Call Center for completion of missed assessments.
Table 4.Schedule of Assessments
Enrollment
Data
CollectionFollow -up Data Collection
Baseline After 1stdose
1 week 2 weeks 4 weeks 8 weeks 12 weeks 6, 9, 12,
18, 24
months
E-consent X
Eligibility criteria confirmed X
Vaccine Dose 1 information
Date
Lot number
SiteX
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PFIZER CONFIDENTIALTable 4.Schedule of Assessments
Enrollment
Data
CollectionFollow -up Data Collection
Baseline After 1stdose
1 week 2 weeks 4 weeks 8 weeks 12 weeks 6, 9, 12,
18, 24
months
Vaccine Dose 2 information
Date
Lot number
SiteX
(and
subsequent
visits if
second
dose not
reported as
received )
Medical record release X** X** X** X** X** X** X**
Demographics
Demographics formX
Medical history
Medical history formX
Employment Information
Employment information formX
Concomitant medications
All current medications
reported at baseline
Changes to medications
reported at follow -up X X*
PROs
Fatigue severity scale
PROMIS Global 10
CDC Impact ScaleX X X X X X X*
COVID -19 Information
Positive COVID -19 test with
date
COVID -19 diagnosis
(presumptive)X X X X X
Health questionnaire
Potential safety events of
interest or clinically significant
events
Pregnancy statusX X X X X X X*
*Follow -up pregnancy, PROs and medication information collected only at 6, 12, 18, and 24 month
intervals.
** Medical record release collected at the time of reporting a health event of interest.
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PFIZER CONFIDENTIAL9.5.2. Call Center Data Collection
The DCRI Call Center serves two main functions in this study :
1. To serve as a “rescue” mechanism to minimize incomplete data from non-response
and loss to follow -up, and
2. To request medical records for confirmation of the occurrence of safet y event s of
interest.
If a participant does not complete an assessment after a notable period of time, the DCRI Call
Center is alerted to contact the participant using participant contact information transferred
from the participant -facing web portal into the com munications sy stem used by the Call
Center. This communications sy stem manages call queues, scheduling, and call processing
information. The study data obtained by the DCRI Call Center is entered directl y into the
web portal. For a given survey assessment, if the participant is not reached after a notable
interval of call attempts, the participant data will be considered missing.
At enrollment, participants provide contact information for a prox y to complete assessments
in the situation where the participa nt is non- responsive to survey prompts. If a prox y cannot
be reached, the call center will continue to contact the participant for a defined period of
time, after which the data for that assessment will be marked as “missing”. Future
assessments will be t argeted for completion according to the planned schedule
9.5.3. Clinical Events Ascertainment (CEA)
The DCRI Call Center requests medical records for all participants reporting a hospitalization
or potential safety event of interest at an y point during follow -up.The following components
of medical records are sought as appropriate:
Emergency room notes
Discharge summary /death summary
Admission history and phy sical exam
Progress/clinic/urgent care notes
Diagnostic tests
Laboratory reports
Medication records
Event assessment proceeds through two phases: confirmation and adjudication. As no
participant -reported events have y et been adjudicated, only events that have undergone the
confirmation process are summarized in this interim report. Future reports will s ummarize
fully adjudicated events. The DCRI Call Center provides a listing of events reported and
status of source documents obtained to the DCRI CEA Confirmation Team for review and
confirmation of the event. During the confirmation phase, the DCRI CEA Cl inical Trial
Coordinator or CEA Project Leader reviews the available source documents for discharge
diagnosis/diagnostic code consistent with the reported event. During the confirmation stage,
each event will be classified as suspected event (unknown), sus pected event (not confirmed),
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PFIZER CONFIDENTIALor probable event (diagnosis code consistent with reported AESI is present in source
document). DCRI CEA provides the listing with these categories to the DCRI Statistical
Group for interim reporting anal ysis. Probable events will then proceed to clinical event
adjudication, where each event will be classified into one of the following categories:
oNegativel y adjudicated event
oPositively adjudicated event
The “probable event” category is defined for interim reporting purposes and does not
constitute a final classification. The below provides the definitions for final event
classifications.
Table 5.Description of Final Event Classifications
# Category Description
1 Suspected event
(unknown)Participant reports an AESI on the web portal, but
requests for medical records are not successful
2 Suspected event (not
confirmed)Medical records are received, but the diagnosis code
list does not indicate an event consistent with the
participant repor t
3 Negativel y adjudicated
eventMedical records are reviewed b y the CEA Committee,
but the event does not meet the event definition in the
CEA Charter or there is insufficient information
4 Positively adjudicated
eventMedical records are reviewed b y the CEA Committee,
and the event does meet the event definition in the
CEA Charter
Upon completion of the CEA Charter and CEA adjudication platform sy stem, these events
will be adjudicated b y CEA phy sician reviewers trained on the HERO- Together study
protocol and CEA charter.
All events classified as “Probable” during the confirmation process will proceed to CEA
adjudication. Following confirmation, for each probable event, the DCRI Clinical Event
Ascertainment (CEA) group will review the medical records and confirm the occurrence of
an event as part of an adjudication process. Safet y event definitions will be specified a priori
in the clinical events ascertainment (CEA) charter as appropriate. Refer to the below
Figure 2for a summary of this process.
The CEA group is responsible for ongoing anal ysis of potential safet y events of interest or
other clinicall y significant diagnoses and of their adjudication as study endpoints.
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PFIZER CONFIDENTIALThe CEA group includes specialists relevant to the safet y events of interest, including
cardiologist s, immunologists, neurologists, and other specialists . Additional details about
review procedures will be provided in an adjudication charter.
Figure 2.Confirmation of Safety Events of Interest During Follow -up
9.6.Bias
At the time of data lock, most outcomes consist of participant report ed safety events of
interest , which may be subject to inaccurate reporting of clinical diagnosis. As events are
adjudicated, outcomes w ill more accuratel y reflect the clinical definition of the events.
Participants electing to participate in the stud y may be more or less motivated to report
events that woul d bias the event rate in unknown way s. In particular, participants may enroll
anytime within 60 day s of vaccine and may elect to participate onl y after experiencing an
event.
9.7.Study Size
This study will aim to enroll 20,000 HCWs and members of their famil ies and communities
who have received a COVID -19 vaccine for prevention of COVID -19. This study size will
help ensure a diverse population of participants with respect to geograph y, primary work
setting, and demographics, and stratification b y important su bgroups of professional role,
age, and region.
As the primary objective is descriptive, this sample size target is designed to ensure adequate
precision for a plausible range of AE and SAE rates in the population of vaccinated HCWs
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PFIZER CONFIDENTIALand members of their families and communities. Table 6 display santicipated precision (95%
confidence interval widths) generated using the Clopper-Pearson exact method for a range of
safet y event rates in a sample of 20,000 participants (overall) and samples of 5,000 and
10,000 p articipants (potential subgroups and allowing for some exclusions due to attrition).
As shown below, precision is high for observed event rates ranging from 0.1% to 20.0%.
Table 6.Estimated Precision of Observed Event Rates *
Observed Rate Exact 95% Confidence
Interval
(n=5,000)Exact 95% Confidence
Interval
(n=10,000)Exact 95% Confidence
Interval
(n=20,000)
0.1% 0.0, 0.23 0.0, 0.18 0.0, 0.15
0.5% 0.32, 0.74 0.37, 0.66 0.41, 0.61
1% 0.74, 1.32 0.81, 1.21 0.87, 1.15
2% 1.63, 2.43 1.73, 2.29 1.81, 2.20
5% 4.41, 5.64 4.58, 5.45 4.70, 5.31
10% 9.18, 10.87 9.42, 10.6 0 9.59, 10.42
20% 18.90, 21.14 19.22, 20.80 19.45, 20.56
*From the Clopper Pearson Exact Method3
The following forecasts for this study are based on experience to date with the HERO
registry : a 2% withdrawal rate, a 75% survey completion rate and enrollment of n=200
participants (1%) who would be excluded from primary anal yses due to receipt of non-
Pfizer-BioNTech vaccine. This would result in withdrawal of n=400 people, exclusion of
n=200 participants due to receiving a non -Pfizer -BioNTech vaccine and no or partial
questionnaire data for ~4,900 participants. Therefore, it isanticipate dthat enrollme nt of
approximately 20,000 participants will result in comprehensive questionnaire data for
approximately 14,500 participants.
To address the second objective regarding assessment of increased risk of safet y events in
vaccinated individuals, informal comp arisons will made with hospitalization rates among
non-vaccinated participants available from the HERO Registry .To formally evaluate
whether vaccinated persons experience increased risk, a self-matched comparative analysis
will be conducted for feasible events, such as those with an adequate case count and known
risk interval. Statistical power to detect various effect sizes assuming a range of background
incidence rates in a self- matched comparative analy sis will be described in the statistical
analysis plan for the final report .
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PFIZER CONFIDENTIAL9.8.Data transformation
Detailed methodology for data transformations, particularl y complex transformations (e.g.,
many raw variables used to derive an anal ytic variable), are documented in the statistical
analysis plan (SAP) and associated programming specifications, which are dated, filed and
maintained by the sponsor (Appendix 4).
Several key general data processing rules implemented during interim reporting include:
Analy sis preference is given to Call Center records over Participant reported records
whenever there is source data from both reporters.
Events/hospitalizations recorded as happening before the first vaccine date are
suppressed from the reporting.
Unique events or hospitalizati ons that have multiple reporting for the same date are
collapsed into a single unique event or hospitalization for that date.
CEA event status for a hospitalization date is applied to all events for that
hospitalization date.
Participants who were vaccinat ed more than 60 day s prior to enrollment or after
enrollment are not included in anal ysis.
9.9.Statistical methods
9.9.1. Main summary measures
Categorical demographics and baseline medical characteristics are summarized using
frequencies and percentages.
Continuous demographics and baseline medical characteristics are summarized by the
count of non- missing values, the mean, the standard deviation, the median, 25thand 75th
percentiles, and the minimum and maximum values.
Participant -reported hospitalizatio ns and safety events of interest are summarized by
frequencies and proportions and for the total number of reports as well as the number of
participants reporting an event.
9.9.2. Main statistical methods
Since this report only includes the participant -reported events, this anal ysis is confined to the
calculation of the summary statistics described in Section 9.9.1 . The summary measures are
provided across several populations based on vaccine received and day s from first
vaccination to enrollment.
These include:
Full Anal ysis/All Consented Population (ACP)
The full anal ysis popul ation is defined as all consented participants. The ACP will be
used for secondary anal yses and s afety evaluations.
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PFIZER CONFIDENTIALPrimary Analysis Safety Population (PASP)
The Primary Anal ysis Safe ty Population is defined as participants who received the
Pfizer -BioNTech COVID-19 vaccine and enrolled in this study within 10 day s of the
first dose of the vaccination. Theprimary objective of the study will be analy zed
within t he PASP to mitigate the risk of enrolment and disproportionate representation
of participants enrolling after experiencing a health event proximate to receipt of
vaccine.
Consented But Not In T he Primary Anal ysis Population (CNPASP)
Consented but not in Primary Anal ysis Safet y Population includes partici pants that
are members of the ACP , but are not members of the PASP . This population includes
thefollowing subsets:
oParticipants who received the Pfizer -BioNTech COVID- 19 vaccine , but
enrolled more than 10 day s after the first dose of the vaccination.
Nohypothesis testing occurred in this anal ysis, and all statements comparing the results
between populations are based solel y on the summary meas ures.
9.9.3. Missing values
In general, the processing of missing values is handled in the statistical programming
specifications in precise detail. Of note, if the first vaccination date is missing on the
vaccination data collection form, then it is obtained from the screening form. Also, if a
subject is missing data on the manufacturer of the vaccine received at one dose but it is
present at another dose for subjects with a two -dose regimen, then we impute the missing
manufacturer from the dose that is prese nt.
9.9.4. Sensitivity analyses
None.
9.9.5. Amendments to the statistical analysis plan
None.
9.10. Quality control
The statistical reporting for this project was conducted under the control of DCRI SOP ST -S-
010 as well as the Pfizer Programming Plan per CT24- WI-GL14 -RF01. Allstatistical
programming work was specified in advance per DCRI SOP ST -S-009 and verified via the
quality control measures per DCRI SOP ST -S-010. The vast majority programing was
confirmed through independent repeated double programming. This was done for all derived
datasets (e.g., SDTM, ADaM) as well as for the tables, figures, and listings that the report is
based on.
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PFIZER CONFIDENTIAL9.11. Protection of human subjects
Subject information and consent
Informed consent Appendix 2 was obtained electronically prior to the subject entering the
study (before initiation of study protocol -specified procedures); the nature, purpose, and
duration of the study was explained to each subject. Each subject was informed that he/she
could withdraw from the study at an y time and for any reason. Each subject was given
sufficient time to consider the implications of the study before deciding whether to
participate. Subjects who chose to participate electronicall y signed an informed consent
document.
Independent Ethics Committee (IEC)/Institutional Review Board (I RB)
The final protocol, an y amendments, and informed consent documentation were reviewed
and approved b y an IRB(s) and/or IEC(s) for each site participating in the study. This direct -
to-participant study is bein g conducted b y DCRI as the sole site.
Ethical conduct of the study
The study was conducted in accordance with legal and regulatory requirements, as well as
with scientific purpose, value and rigor and follow generall y accepted research practices
described in the Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the
International Societ y for Pharmacoepidemiology , and Good Epidemiological Practice (GEP)
guidelines issued b y the International Epidemiological Association (IEA) .
10.RESULTS
At the time of this report, no parti cipant reported events had undergone full adjudication.
Participant -reported events for which medical records were available had undergone the
confirmation process (see Section 9.5.3 ). As such, all events in this report should be
interpreted with caution .
10.1. Participants
The data for this interim report include subjects enrolling before 29 April 2021 , prior to a
protocol amendment expanding eligibility criteria to include participants beyond health care
workers. The following CONSORT diagram in Figure 3shows the flow of the subjects
through the stud y.
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PFIZER CONFIDENTIALFigure 3. CONSORT Diagram
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PFIZER CONFIDENTIALSurvey completion rates for the applicable time period of this interim report are described in
Table 7, Completion rates for anal ysis populations. Of note ,survey completi onrates are
reflect ive of the fact that the study is ongoing and partic ipants may not have reached a survey
point. Additionally participants were eligible to enroll up to 60 day s after vaccination and
may not have required a survey , e.g., at week 1.
Table 7.Completion rates for analysis populations
All Consented
Population (ACP)
(N=7824)Primary Analysis Safety
Population (PASP)
(N=2511)Consented but not in Primary
Analysis Safety Population
(CNPASP)
(N=5313)
Participants
Completed
Survey atExpected Completed Expected Completed Expected Completed
Week 1 3767 / 7824
(48.1%)709 / 3767
(18.8%)2511 / 2511
(100%)446 / 2511
(17.8%)1256 / 5313
(23.6%)263 / 1256
(20.9%)
Week 2 4515 / 7824
(57.7%)1700 / 4515
(37.7%)2510 / 2511
(>99.0%)871 / 2510
(34.7%)2005 / 5313
(37.7%)829 / 2005
(41.3%)
Week 4 6677 / 7824
(85.3%)3763 / 6677
(56.4%)2502 / 2511
(>99.0%)1570 / 2502
(62.7%)4175 / 5313
(78.6%)2193 / 4175
(52.5%)
Week 8 7685 / 7824
(98.2%)4522 / 7685
(58.8%)2478 / 2511
(98.7%)1609 / 2478
(64.9%)5207 / 5313
(98.0%)2913 / 5207
(55.9%)
Week 12 5910 / 7824
(75.5%)5319 / 5910
(90.0%)2175 / 2511
(86.6%)1946 / 2175
(89.5%)3735 / 5313
(70.3%)3373 / 3735
(90.3%)
Source: Table 15.5.2
Note: Expected completion is based on time from vaccination date. Many of the first participants to enroll did so very
close to the end of the inclusion criteria. As such, the window between enrollment and completion of the first set of
surveys was very short, and many were not able to complete those surveys withi n the time allotted for rescue. This
resulted in depressed Week 1 and Week 2 survey completion rates
10.2. Descriptive data
The demographic characteristics of the ACP and PASP can be found in Table 15.1.1 ,
Figure 4and Figure 5. Some observations from the demographics table include:
The PASP subset has less missing sex, race, and ethnicity data than the broader ACP .
About 75% of the overall ACP and subset PASP and CNPASP populations are between
30 and 60 years of age (76.9% of ACP, 80.1% of PASP, and 75.4% of CNPASP)
Most participants are f emale in the overall ACP (66.1%) and the subset PASP (70.3%)
Most participants in the overall ACP ( 72.1%) and the PASP subset reported White race.
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PFIZER CONFIDENTIALMost participants in the overall ACP (74.1%) and PASP subset (82.0%) identified asNot
Hispanic or Latino ethnicity .
Other descriptive findings include:
The proportion of participants who withdrew from the study is less than 2% in the overall
ACP (1.2%) and inthe PASP (1.8% ) (see Table 15.5.1). Theseis less than the estimated
forecast of 2 % described in the protocol (see Protocol S ection 9.5) . Most participants
who withdrew cited “other” reason (60%). The most frequent ly cited specific reason for
subject withdraw al wasdue to the study being too time -intensive (38%).
The t op four medical histories are: obesity /overweight ( PASP : 23.6%, ACP : 20.9%),
hypertensi on (PASP : 11.4%, AC P: 11.3%), a sthma ( PASP : 11.1%, AC P: 10.7%), and
previous COVID- 19 diagnosis ( PASP : 8.8%, AC P: 8.3%) (see Table 15.1.2.1) When
looking at these four histories by vaccination manufacturer, slightl y higher proportions of
these histories were observed in the Pfizer -BioNTech vaccine group compared with the
othervaccine sgroup (see Table 15.1.2.2).
The proportions of b aseline pregnancy and 6 month prior vaccination status were also
numericall y similar for the two populations (PASP: 81.1%, ACP: 78.4%) (see Table
15.1.4).
Figure 4
.Distribution of Age in the PASP and CNPASP
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PFIZER CONFIDENTIALFigure 5.Baseline Demographics of the PASP and CNPASP
10.3. Main results
Hospitalization reported by participants for the overall ACP and PASP and CNP ASP subsets
are reported. Additional details are provided for the PASP, the population of interest for the
primary objective of the study . At the time of this report, no participant reported events had
undergone full adjudication. However, an y participant -reported events for which medical
records had been received have undergone the confirmation process ( Section 9.5.3). As such,
event counts in this interim report are likely an underrepresentation of the final count and
should be interpreted with caution.
Participants reported unplanned hospitalization any time after receipt of 1 dose of COVID -19
vaccine for subjects enrolled (as of 29 April 2021) .
Primary Anal ysis Safet y Population
oFewer than 1% (16/2511) of participants reported hospitalization (see Table
15.3.1.1).
oHospitalization was reported in 5.9% (6/101) of participants who also reported
that they or their partner were pregnant at the time of vaccination (see Table
15.3.1.4)
oThe age group reporting the highest percentage of hospitalizations is 30-39 year
old participants and the rate is <1% (7/915) (see Table 15.3.1.5 )
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PFIZER CONFIDENTIALoReported hospitalizations were <1% (1/181) in patients identify ing as
immunocompromised (see Table 15.3.1.6)
Full Anal ysis / All Consented Population
oFewer than 1% (63/7824) of participants reported hospitalization (see Table
15.3.1.1).
Consented But Not In The Primary Anal ysis Population
oFewer than 1% ( 47/5313 ) of participants reported hospitalization (see Table
15.3.1.1).
Participant reported S afety Event of Interest any time after receipt of at least 1 dose of
COVID -19 through 29 April 2021:
Primary Anal ysis Safet y Population
oA safet y event of interest was reported in 12.7% (320/2511) of participants (see
Table 15.3.2.1.1).
oAs shown in Figure 6, the top 5 self -reported safety events of interest were:
1.Other (9.4%; 236/2511) (see Table 15.3.2.1.1)
2. Joint stiffness or pain (e.g., arthralgia, arthritis) (1.3% ; 32/2511) (see
Table 15.3.2.1.1)
3.Pregnancy -related issue (<1%; 19/2511) (see Table 15.3.2.1.1 )
4.Non-severe allergic reaction (<1%; 15/2511) (see Table 15.3.2.1.1 )
5.COVID -19 infection (<1%; 15/2511) (see Table 15.3.2.1.1 )
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PFIZER CONFIDENTIALFigure 6.Counts of Participants who had Adverse Events of Special Interest in the
PAS P
oOne death was reported but it was not reported as COVID -19 related (see Listing
7.7.2).
oApproximately 16.8% (17/101) of participants and their partners reporting
pregnancy reported any safet y events of interest (see Table 15.3.2.1.4 )
oThe proportion of participants reporting at least one safet y event in this population
were 21.5% (39/181) forimmunocompromised participants and 12.1% for
participants not identify ing as immunocompromised (281/2330) (see Table
15.3.2.1.6 )
oThe age group with highest proportion (13.6%; 124/915 ) of participants reporting
at least one safet y event is 30-39 year old (see Table 15.3.2.1.5)
Full Ana lysis / All Consented Population
oAt least one safety event of interest after an y dose of COVID -19 vaccine was
reported b y 11.9% (928/7824) of participants (see Table 15.3.2.1.1).
oTwo death s were reported, but they were not reported as COVID -19 related (see
Listing 7.7.2).
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PFIZER CONFIDENTIALConsented But Not In The Primary Anal ysis Population
o11.4% (608/5313) of participants reported a safety event of interest (see Table
15.3.2.1.1 ).
oOne death was reported, but it was not reported as C OVID -19 related (see Listing
7.7.2).
10.4. Other analyses
None.
10.5. Safety event s / adverse reactions
The primary objective of this study is to describe the incidence rates of safety events of
interest and other clinically significant events among US healthcare workers, their families,
and members of their communities who are vaccinated with the Pfizer-BioNTech COVID-19
vaccine following Emergency Use Authorization. At the time of the data cut for this interim
report, only participant -reported information is available and these events have not
undergone full adjudicat ion.Per the statistical analy sis plan, only the proportion of
participants who report safet y events of interest arereported. Rates will be reported in future
reports as data on adjudicat ed events mature. All event tables are summarized in
Section 10.3 .
11.DISCUSSION
11.1. Key results
Data in this report are limited to the population of healthcare workers enrolled prior to the
expansion to family and community members.
This interim report presents descriptive statistics on the demographic and clinical
characteristics of the first 7824 participants enrolled in HERO -Together between 17
December 2020 and 29 April 2021. Given the theoretical potential for preferential self -
enrollment of individuals experiencing a safet y event (or earl y symptoms of a safety event),
the primary analy sis safety population was limited to those who received the irfirst dose of
the Pfizer -BioNTech COVID- 19 vaccine within 10 day s (n=2511). The median day s since
vaccination among participants in this group enrolled as of 29 April 2021 was just3 day s,
supporting the characterization of this safety population as prospe ctive and minimizing the
potential for bias due to selective over-enrollment of higher risk participants at later time
periods.
The HERO-Together study was designed to maximize comprehensive capture of safet y
information over time through a secure, partic ipant -facing web portal with periodic reminder
emails and a centralized call center to minimize missed survey s and reduce loss -to-follow -up.
For example, approximately three -quarters of the consented population w ereexpected to
complete the week 12 survey as of 29 April 2021; of these, approximately 90% of
participants completed survey s as expected. HERO- Together withdrawal for the all-
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PFIZER CONFIDENTIALconsented population was also low ( 1.2%), with the primary reported reasons for withdrawal
including “other” (58.9%) and “too -time intensive” (37.8%).
Population demographics reflect the healthcare worker inclusion criterion, the online nature
of the study and the requirement for vaccination prior to enrollment. Consistent with
participants in the HERO Registry , the population of HERO -Together is primarily white,
female, and under the age of 50.4A recent report from the US Department of Health and
Human Services, He alth Resources and Services Administration suggests that the
demographic distribution of participants may in part be a function of professional role.5
Nationally, men represent approximately 52.8% of the US healthcare worker workforce, with
greater male representation among ph ysicians (65.1%) and EMTs/Paramedics (68.5%), and
less representation among registered nurses (9.6%) and medical assistants (7.8%). Given that
the HERO Registry has greater representation from registered nurses and medical assistants,5
the predominance of female gender is consistent with expectations. Additionally,
Black/African American healthcare workers represent 11.6% of the national healthcare
worker population, but only 3.0% of th e consented HERO -Together population. A number of
factors, including lower initial national vaccination rates among racial/ethnic minority
populations and lower representation of non -white participants in the HERO Registry , may
have contributed to lower en rollment of Black/African American participants.
Prevalence of common cardiovascular risk factors, including h ypertension, obesity, and
diabetes mellitus, was relatively low,6,7likely in part due to the younger age of study
participants, and that they are generally healthy workers. Fewer than 1% of participants
reported a prior history of significant cardiovascular disease, such as heart failure, stroke, or
myocardial infarction. However, prevalence of bo th asthma and autoimmune disease were
comparable to current estimates of general population prevalence.8,9Pregnant participants
comprised 3.4% of all HERO- Together participants with complete information on pregnancy ,
with the majority reporting receipt of other vaccines in the 6 months prior to the first
COVID -19 vaccine dose. The proportion of participants reporting a previous diagnosis of
COVID -19 at enrollment was 8.4%, in line with cumulative incidence estimates for total
confirmed cases in the US.10
Participant self -reported safet y event data collected as of 29 April 2021 have not y et
undergone full adjudicatio n. Given the participant -reported nature of this information, these
events should be regarded as preliminary pending full adjudication (review of source
documentation to determine whether standard event definitions are met ). As of 29 April
2021 , the participant reported hospitalization proportion was 0.8% in the total consented
population and 0.6% in the PASP . Based on the initial confirmation process, 25.4% of
participant self -reported events resulted in classification as “probable ”based on presence of
diagnostic information in source materials that was consistent with a safet y event of interest.
This proportion was similar in the PASP , though the number of probable hospitalized self-
reported events to date was small (n=4). In the total consented population, 11.5% of
participants reported a non- hospitalized AESI . Of these, the majorit ywere still pending
medical record review and confirmation; however , 24.8% were classified as suspected, and
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PFIZER CONFIDENTIAL1.0% were classified as probable in the total consented population. Proportions were similar
in the primary consented safet y population.
The most commonly reported AESIs in the total study population included joint stiffness or
pain (1.4%), pregnancy -related issue (0.7%), non -severe allergic reaction (0.6%), and
COVID -19 infection (0.5%). The most commonly reported AESIs in the PASP were similar
in magnitude, with 1.3% reporting joint stiffness or pain, 0.8% pregnancy -related issue, 0.6%
non-severe allergic reaction, and 0.6% COVID -19 infection. Approximately 8.6% of
participants reported an event classified as “other” in the total popul ation, with a comparable
proportion in the primary safet y population (9.4%). Source documentation will be requested
for these participant -reported events to determine occurrence of an y AESI s consistent with
study definitions.
11.2. Limitations
This study is intended to provide comprehensive real- world safet y information about the
Pfizer -BioNTech COVID-19 vaccine in US healthcare workers. To date, the number of
participant -reported events was low for most pre -specified AESIs, and all events were still in
the pr ocess of full adjudication. Prior studies have demonstrated bias in participant -reported
event information. Therefore, all reported AESIs in this report should be interpreted with
caution, particularl y given the large number of reported AESIs collected and the multiple
subgroups of interest. Additionally, allowing for enrollment several days or weeks following
vaccination may introduce the potential for preferential self -enrollment of individuals
experiencing a safet y event (or earl y symptoms of a safet y event). As a result, the primary
safet y population is restricted individuals enrolling within 10 days of first vaccination dose.
Asparticipants enroll voluntarily , the general izability of study results is a function of the
diversity of the enrolled sample. While the inclusion criteria for HERO -Together are
intentionally broad, theracial/ethnic diversit y of the initial population is lower than
anticipated. Future efforts to enhance diversity will include recruitment efforts that
preferen tially target racial/ethnic minority populations. Finally , thisobservational study is
susceptible to confounding due to measured and unmeasured confounders. Future anal yses of
adjudicated events will implement bias reduction strategies including use of st andardized
event definitions and self -matched comparative analy ses.
11.3. Interpretation
This report includes interim descriptive anal yses of participant -reported outcomes after
vaccination which may not be due to vaccination itself. Given that data collectio n is
underway and lack of adjudicated event availability at the time of this first interim report and
the known limitations of participant- reported event information, all events in this report
should be interpreted with caution. Final anal yses will use sel f-matched controls and
subgroup anal yses of adjudicated events to inform risk -benefit assessment of the Pfizer-
BioNTech COVID -19 vaccine in this real- world population.
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PFIZER CONFIDENTIAL11.4. Generalizability
As described in Section 11.1 Key Results, the distribution of participant characteristics in the
enrolled population to date is consistent with expectations, given the HERO Registry
population and patterns of early vaccination uptake. The inclusion criteria for HERO -
Together (including the definition of “healthcare worker” as an yone who works in a setting
where people receive healthcare) are intentionall y broad . Additionally , use of an online web
portalfor screening, consent, and data collection enables study participation for a
geographically diverse population, and withdrawal rates to date are low, minimizing potential
selection bias. However, racial/ethnic diversity of the initial population is l ower than
anticipated.
12.OTHER INFORMATION
Not applicable.
13.CONCLUSIONS
The initial study population enrolled in HERO-Together is primaril y white, female, and had a
low comorbidity burden at baseline. The proportion of participant s report ingsafet y event s of
interest, including hospitalizations, were low and most commonly included joint stiffness or
pain, pregnancy -related issue, non- severe allergic reaction, and COVID -19 infection. Future
analyses of adjudicated events will provide additional insight into the rate sof safet y events in
vaccinated persons and any increased risk of certain safet y events of interest after vaccination
overall and among subpopulations of interest.
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PFIZER CONFIDENTIAL14.REFERENCES
1. Brighton Collaboration Priority List of Adverse Events of Special Inter est: COVID -19.
Accessed March 4, 2021. Available: https://brightoncollaboration.us/priority -list-aesi-
covid/.
2. Shimabukuro T. "Enhanced safet y monitoring for COVID -19 vaccines in early phase
vaccination." September 22, 2020. Available:
https://www.cdc.gov/ vaccines/acip/meetings/downloads/slides -2020 -09/COVID -03-
Shimabukuro.pdf.
3. C.J. Clopper ESP. The Use of Confidence or Fiducial L imits Illustrated in the Case of
the Binomial. Biometrika, Volume 26, I ssue 4, December 1934, Pages 404 –413,
https://doi.org/10.1093/biomet/26.4.404.
4. Forrest CB, Xu H, Thomas LE, et al. Impact of the Earl y Phase of the COVID -19
Pandemic on US Healthcare Workers: Results from the HERO Registry . J Gen Intern
Med. 2021;36(5):1319- 1326.
5. U.S. Department of Health and Human Services Healt h Resources and Services
Administration. Sex, Race, and Ethnic Diversity of U.S. Health Occupations (2011-
2015). August 2017. Available: https://bhw.hrsa.gov/sites/default/files/bureau -health-
workforce/data -research/diversity -us-health- occupations.pdf.
6. Virani SS, Alonso A, Aparicio HJ, et al. Heart Disease and Stroke Statistics-2021
Update: A Report From the American Heart Association. Circulation.
2021;143(8):e254 -e743.
7. Centers for Disease Control and Prevention. Underly ing Cause of Death, 1999 –2018.
CDC W ONDER Online Database. Atlanta, GA: Centers for Disease Control and
Prevention; 2018. Accessed March 12, 2020.
8. Centers for Disease Control and Prevention. Most Recent National Asthma Data. 2019.
Available: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm.
9. National Institutes of Health Autoimmune Diseases Coordinating Committee. "Progress
in Autoimmune Disease Research". [Report to Congress]. Available:
https://www.niaid.nih.gov/sites/default/f iles/adccfinal.pdf.
10. Johns Hopkins University & Medicine Coronavirus Resource Center. COVID-19
United States Cases by County . Accessed May 25, 2021. Available:
https://coronavirus.jhu.edu/us- map.
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PFIZER CONFIDENTIAL15.LIST OF SOURCE TABLE S AND FIGURES
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Table 15.5.1 Page 1of 2
BNT162b2 Protocol C4591008
Disposition and Retention
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
3: Vaccination dates are based on participants reported dates.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_disp.sas on 24MAY2021 12:44 Page 1of 284 All Consented Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Participants Completed The Study 0 / 7824 (0%) 0 / 2511 (0%) 0 / 5313 (0%)
Participants Alive And Remaining In The Study 7731 / 7824 (98.8%) 2466 / 2511 (98.2%) 5265 / 5313 (>99.0%)
Days In The Study Since 1st Vaccine3
N 7731 2466 5265
Mean (SD) 130.6 (19.42) 134.8 (17.64) 128.6 (19.90)
Median (Q1, Q3) 136.0 (126.0, 143.0) 141.0 (132.0, 145.0) 134.0 (124.0, 141.0)
Min, Max 14, 176 14, 155 14, 176
Days Between 1st Vaccine And Enrollment
N 7824 2511 5313
Mean (SD) 20.7 (18.09) 3.6 (2.74) 28.7 (16.62)
Median (Q1, Q3) 16.0 (4.0, 34.0) 3.0 (1.0, 5.0) 28.0 (15.0, 42.0)
Min, Max 1, 61 1, 11 1, 61
Days Between 1st Vaccine And 2nd Vaccine3
N 6035 2133 3902
Mean (SD) 24.3 (5.62) 22.7 (4.72) 25.2 (5.88)
Median (Q1, Q3) 22.0 (22.0, 28.0) 22.0 (22.0, 23.0) 23.0 (22.0, 29.0)
Min, Max 2, 109 2, 92 2, 109
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Table 15.5.1 Page 2of 2
BNT162b2 Protocol C4591008
Disposition and Retention
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
3: Vaccination dates are based on participants reported dates.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_disp.sas on 24MAY2021 12:44 Page 2of 284 All Consented Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Participants Who Did Not Complete The Study 93 / 7824 (1.2%) 45 / 2511 (1.8%) 48 / 5313 (<1.0%)
Death 2 / 93 (2.2%) 1 / 45 (2.2%) 1 / 48 (2.1%)
Cause Of Death Related To COVID-19 0 / 2 (0%) 0 / 1 (0%) 0 / 1 (0%)
Lost To Follow Up 0 / 93 (0%) 0 / 45 (0%) 0 / 48 (0%)
Withdrawal By Subject 90 / 93 (96.8%) 44 / 45 (97.8%) 46 / 48 (95.8%)
Study Terminated By Sponsor 0 / 93 (0%) 0 / 45 (0%) 0 / 48 (0%)
Other 1 / 93 (1.1%) 0 / 45 (0%) 1 / 48 (2.1%)
Reason For Withdrawal By Subjects
Technical Problems 0 / 90 (0%) 0 / 44 (0%) 0 / 46 (0%)
Too Time Intensive 34 / 90 (37.8%) 17 / 44 (38.6%) 17 / 46 (37.0%)
Illness 0 / 90 (0%) 0 / 44 (0%) 0 / 46 (0%)
Non-compliance 0 / 90 (0%) 0 / 44 (0%) 0 / 46 (0%)
Safety 3 / 90 (3.3%) 1 / 44 (2.3%) 2 / 46 (4.3%)
Behavioral 0 / 90 (0%) 0 / 44 (0%) 0 / 46 (0%)
Administrative Reasons 0 / 90 (0%) 0 / 44 (0%) 0 / 46 (0%)
Other 53 / 90 (58.9%) 26 / 44 (59.1%) 27 / 46 (58.7%)
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Figure 15.5.1.1 1 of 1
BNT162b2 Protocol C4591008
Cumulative Rate of Study Discontinuation – All Consented Population
All Consented Population is defined as all enrolled participants.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
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Figure 15.5.1.2 1 of 1
BNT162b2 Protocol C4591008
Cumulative Rate of Study Discontinuation –Primary Analysis Safety Population
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/figures/f_disc_safe.sas on 24MAY2021 12:45 Page 4of 284
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Table 15.5.2 Page 1of 1
BNT162b2 Protocol C4591008
Visit Completion
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
3: For the J une 2021 interim report, we had 19 records at Month 12 and 1 record at Month 18 which were impossible and that have been supp ressed because they were created by
interviewer error.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR 2021 Source Data: ADSL, ADVISIT
Generated from /dcri/ct/hero_together/tables/t_visit.sas on 24MAY2021 12:45 Page 5of 284 All Consented Population1
(N=7824)Primary Analysis Safety Population2
(N=2511)Consented but not in Primary Analysis
Safety Population
(N=5313)
Participants Completed Survey at3Expected Completed Expected Completed Expected Completed
Week 1 3767 / 7824 (48.1%) 709 / 3767 (18.8%) 2511 / 2511 (100%) 446 / 2511 (17.8%) 1256 / 5313 (23.6%) 263 / 1256 (20.9%)
Week 2 4515 / 7824 (57.7%) 1700 / 4515 (37.7%) 2510 / 2511 (>99.0%) 871 / 2510 (34.7%) 2005 / 5313 (37.7%) 829 / 2005 (41.3%)
Week 4 6677 / 7824 (85.3%) 3763 / 6677 (56.4%) 2502 / 2511 (>99.0%) 1570 / 2502 (62.7%) 4175 / 5313 (78.6%) 2193 / 4175 (52.5%)
Week 8 7685 / 7824 (98.2%) 4522 / 7685 (58.8%) 2478 / 2511 (98.7%) 1609 / 2478 (64.9%) 5207 / 5313 (98.0%) 2913 / 5207 (55.9%)
Week 12 5910 / 7824 (75.5%) 5319 / 5910 (90.0%) 2175 / 2511 (86.6%) 1946 / 2175 (89.5%) 3735 / 5313 (70.3%) 3373 / 3735 (90.3%)
Month 6 0 0 0 0 0 0
Month 9 0 0 0 0 0 0
Month 12 0 0 0 0 0 0
Month 18 0 0 0 0 0 0
Month 24 0 0 0 0 0 0
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Table 15.1.1 Page 1of 2
BNT162b2 Protocol C4591008
Baseline Demographics
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Cr eation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_demog.sas on 24MAY2021 12:44 Page 6of 284 Participant CharacteristicsAll Consented Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Age At First Dose In Years
N 7823 2511 5312
Mean (SD) 42.7 (11.63) 42.6 (11.16) 42.7 (11.85)
Median (Q1, Q3) 40.9 (33.6, 51.1) 40.6 (33.8, 50.5) 41.1 (33.3, 51.4)
Min, Max 18, 121 19, 85 18, 121
Missing 1 0 1
Age At First Dose In Years
18 -29 1051 / 7824 (13.4%) 282 / 2511 (11.2%) 769 / 5313 (14.5%)
30 -39 2625 / 7824 (33.6%) 915 / 2511 (36.4%) 1710 / 5313 (32.2%)
40 -49 1989 / 7824 (25.4%) 657 / 2511 (26.2%) 1332 / 5313 (25.1%)
50 -59 1402 / 7824 (17.9%) 439 / 2511 (17.5%) 963 / 5313 (18.1%)
60 -69 688 / 7824 (8.8%) 197 / 2511 (7.8%) 491 / 5313 (9.2%)
70 And Above 68 / 7824 (<1.0%) 21 / 2511 (<1.0%) 47 / 5313 (<1.0%)
Missing 1 / 7824 (<1.0%) 0 1 / 5313 (<1.0%)
Sex
Female 5170 / 7824 (66.1%) 1766 / 2511 (70.3%) 3404 / 5313 (64.1%)
Male 1243 / 7824 (15.9%) 481 / 2511 (19.2%) 762 / 5313 (14.3%)
Undifferentiated 4 / 7824 (<1.0%) 1 / 2511 (<1.0%) 3 / 5313 (<1.0%)
Missing 1407 / 7824 (18.0%) 263 / 2511 (10.5%) 1144 / 5313 (21.5%)
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Table 15.1.1 Page 2of 2
BNT162b2 Protocol C4591008
Baseline Demographics
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Cr eation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_demog.sas on 24MAY2021 12:44 Page 7of 284 Participant CharacteristicsAll Consented Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Race
White 5644 / 7824 (72.1%) 1987 / 2511 (79.1%) 3657 / 5313 (68.8%)
Black Or African American 191 / 7824 (2.4%) 48 / 2511 (1.9%) 143 / 5313 (2.7%)
American Indian Or Alaska Native 18 / 7824 (<1.0%) 8 / 2511 (<1.0%) 10 / 5313 (<1.0%)
Asian 340 / 7824 (4.3%) 116 / 2511 (4.6%) 224 / 5313 (4.2%)
Native Hawaiian Or Other Pacific Islander 6 / 7824 (<1.0%) 2 / 2511 (<1.0%) 4 / 5313 (<1.0%)
Multiple 126 / 7824 (1.6%) 51 / 2511 (2.0%) 75 / 5313 (1.4%)
Not Reported 71 / 7824 (<1.0%) 26 / 2511 (1.0%) 45 / 5313 (<1.0%)
Unknown 21 / 7824 (<1.0%) 10 / 2511 (<1.0%) 11 / 5313 (<1.0%)
Missing 1407 / 7824 (18.0%) 263 / 2511 (10.5%) 1144 / 5313 (21.5%)
Ethnicity
Hispanic Or Latino 373 / 7824 (4.8%) 108 / 2511 (4.3%) 265 / 5313 (5.0%)
Not Hispanic Or Latino 5797 / 7824 (74.1%) 2059 / 2511 (82.0%) 3738 / 5313 (70.4%)
Not Reported 192 / 7824 (2.5%) 67 / 2511 (2.7%) 125 / 5313 (2.4%)
Unknown 55 / 7824 (<1.0%) 14 / 2511 (<1.0%) 41 / 5313 (<1.0%)
Missing 1407 / 7824 (18.0%) 263 / 2511 (10.5%) 1144 / 5313 (21.5%)
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Table 15.1.2.1 Page 1of 1
BNT162b2 Protocol C4591008
Baseline Medical History (Participant Reported)
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_medhx.sas on 24M AY2021 12:45 Page 8of 284 Reported TermAll Consented
Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Hypertension (High Blood Pressure) 888 / 7824 (11.3%) 286 / 2511 (11.4%) 602 / 5313 (11.3%)
Diabetes Mellitus 234 / 7824 (3.0%) 86 / 2511 (3.4%) 148 / 5313 (2.8%)
Obesity/Overweight 1633 / 7824 (20.9%) 593 / 2511 (23.6%) 1040 / 5313 (19.6%)
Prior Heart Attack 20 / 7824 (<1.0%) 6 / 2511 (<1.0%) 14 / 5313 (<1.0%)
Heart Failure/Cardiomyopathy 27 / 7824 (<1.0%) 7 / 2511 (<1.0%) 20 / 5313 (<1.0%)
Coronary Artery Disease 43 / 7824 (<1.0%) 16 / 2511 (<1.0%) 27 / 5313 (<1.0%)
Prior Stroke Or Mini -stroke (TIA) 32 / 7824 (<1.0%) 10 / 2511 (<1.0%) 22 / 5313 (<1.0%)
Peripheral Arterial Or Vascular Disease 25 / 7824 (<1.0%) 6 / 2511 (<1.0%) 19 / 5313 (<1.0%)
Chronic Obstructive Pulmonary Disease (COPD) 13 / 7824 (<1.0%) 3 / 2511 (<1.0%) 10 / 5313 (<1.0%)
Asthma 840 / 7824 (10.7%) 279 / 2511 (11.1%) 561 / 5313 (10.6%)
Smoking 182 / 7824 (2.3%) 50 / 2511 (2.0%) 132 / 5313 (2.5%)
Chronic Kidney Disease 26 / 7824 (<1.0%) 10 / 2511 (<1.0%) 16 / 5313 (<1.0%)
Cancer (Localized) 126 / 7824 (1.6%) 44 / 2511 (1.8%) 82 /5313 (1.5%)
Cancer (Metastatic) 13 / 7824 (<1.0%) 5 / 2511 (<1.0%) 8 / 5313 (<1.0%)
Lymphoma 12 / 7824 (<1.0%) 0 12 / 5313 (<1.0%)
Leukemia 6 / 7824 (<1.0%) 1 / 2511 (<1.0%) 5 / 5313 (<1.0%)
Liver Disease 29 / 7824 (<1.0%) 16 / 2511 (<1.0%) 13 / 5313 (<1.0%)
Peptic Ulcer Disease 27 / 7824 (<1.0%) 9 / 2511 (<1.0%) 18 / 5313 (<1.0%)
Connective Tissue Disease 50 / 7824 (<1.0%) 18 / 2511 (<1.0%) 32 / 5313 (<1.0%)
Autoimmune Disease 423 / 7824 (5.4%) 140 / 2511 (5.6%) 283 / 5313 (5.3%)
Organ Transplant 6 / 7824 (<1.0%) 3 / 2511 (<1.0%) 3 / 5313 (<1.0%)
HIV/AIDS 13 / 7824 (<1.0%) 4 / 2511 (<1.0%) 9 / 5313 (<1.0%)
Previous COVID -19 Diagnosis 650 / 7824 (8.3%) 221 / 2511 (8.8%) 429 / 5313 (8.1%)
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Table 15.1.2.2 Page 1of 2
BNT162b2 Protocol C4591008
Baseline Medical History Stratified by Pfizer vs Non-Pfizer Vaccine (Participant Reported) and by Enrolment Within 10
Days
1: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021 :07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_medhx_byvax.sas on 24MAY2021 12:45 Page 9of 284 Pfizer COVID 19 Vaccine
(N=5399)Other COVID 19 Vaccine Manufacturer
(N=2425)
Reported TermEnrolled within 10 days
after vaccine1
(N=2511)Enrolled more than 10 days
after vaccine
(N=2888)Enrolled within 10 days
after vaccine
(N=835)Enrolled more than 10 days
after vaccine
(N=1590)
Hypertension (high blood pressure) 286 / 2511 (11.4%) 384 / 2888 (13.3%) 80 / 835 (9.6%) 138 / 1590 (8.7%)
Diabetes mellitus 86 / 2511 (3.4%) 95 / 2888 (3.3%) 18 / 835 (2.2%) 35 / 1590 (2.2%)
Obesity/Overweight 593 / 2511 (23.6%) 642 / 2888 (22.2%) 164 / 835 (19.6%) 234 / 1590 (14.7%)
Prior heart attack 6 / 2511 (<1.0%) 9 / 2888 (<1.0%) 1 / 835 (<1.0%) 4 / 1590 (<1.0%)
Heart failure/cardiomyopathy 7 / 2511 (<1.0%) 14 / 2888 (<1.0%) 2 / 835 (<1.0%) 4 / 1590 (<1.0%)
Coronary artery disease 16 / 2511 (<1.0%) 19 / 2888 (<1.0%) 3 / 835 (<1.0%) 5 / 1590 (<1.0%)
Prior stroke or mini -stroke (TIA) 10 / 2511 (<1.0%) 15 / 2888 (<1.0%) 3 / 835 (<1.0%) 4 / 1590 (<1.0%)
Peripheral arterial or vascular disease 6 / 2511 (<1.0%) 10 / 2888 (<1.0%) 4 / 835 (<1.0%) 5 / 1590 (<1.0%)
Chronic obstructive pulmonary disease (COPD) 3 / 2511 (<1.0%) 4 / 2888 (<1.0%) 3 / 835 (<1.0%) 3 / 1590 (<1.0%)
Asthma 279 / 2511 (11.1%) 338 / 2888 (11.7%) 87 / 835 (10.4%) 136 / 1590 (8.6%)
Smoking 50 / 2511 (2.0%) 73 / 2888 (2.5%) 28 / 835 (3.4%) 31 / 1590 (1.9%)
Chronic kidney disease 10 / 2511 (<1.0%) 14 / 2888 (<1.0%) 1 / 835 (<1.0%) 1 / 1590 (<1.0%)
Cancer (localized) 44 / 2511 (1.8%) 58 / 2888 (2.0%) 6 / 835 (<1.0%) 18 / 1590 (1.1%)
Cancer (metastatic) 5 / 2511 (<1.0%) 5 / 2888 (<1.0%) 1 / 835 (<1.0%) 2 / 1590 (<1.0%)
Lymphoma 0 8 / 2888 (<1.0%) 0 4 / 1590 (<1.0%)
Leukemia 1 / 2511 (<1.0%) 4 / 2888 (<1.0%) 0 1 / 1590 (<1.0%)
Liver Disease 16 / 2511 (<1.0%) 10 / 2888 (<1.0%) 2 / 835 (<1.0%) 1 / 1590 (<1.0%)
Peptic ulcer disease 9 / 2511 (<1.0%) 11 / 2888 (<1.0%) 2 / 835 (<1.0%) 5 / 1590 (<1.0%)
Connective tissue disease 18 / 2511 (<1.0%) 17 / 2888 (<1.0%) 3 / 835 (<1.0%) 12 / 1590 (<1.0%)
Autoimmune disease 140 / 2511 (5.6%) 182 / 2888 (6.3%) 31 / 835 (3.7%) 70 / 1590 (4.4%)
Organ transplant 3 / 2511 (<1.0%) 3 / 2888 (<1.0%) 0 0
HIV/AIDS 4 / 2511 (<1.0%) 5 / 2888 (<1.0%) 1 / 835 (<1.0%) 3 / 1590 (<1.0%)
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Table 15.1.2.2 Page 2of 2
BNT162b2 Protocol C4591008
Baseline Medical History Stratified by Pfizer vs Non-Pfizer Vaccine (Participant Reported) and by Enrolment Within 10
Days
1: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021 :07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generated from /dcri/ct/hero_together/tables/t_medhx_byvax.sas on 24MAY2021 12:45 Page 10of 284 Pfizer COVID 19 Vaccine
(N=5399)Other COVID 19 Vaccine Manufacturer
(N=2425)
Reported TermEnrolled within 10 days
after vaccine1
(N=2511)Enrolled more than 10 days
after vaccine
(N=2888)Enrolled within 10 days
after vaccine
(N=835)Enrolled more than 10 days
after vaccine
(N=1590)
Previous COVID -19 diagnosis 221 / 2511 (8.8%) 237 / 2888 (8.2%) 80 / 835 (9.6%) 112 / 1590 (7.0%)
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Table 15.1.3 Page 1of 1
BNT162b2 Protocol C4591008
Baseline Medications
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
Generate d from /dcri/ct/hero_together/tables/t_med_baseline.sas on 24MAY2021 12:45 Page 11of 284 All Consented
Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Participants With Any Medications Below 490 / 7824 (6.3%) 176 / 2511 (7.0%) 314 / 5313 (5.9%)
Inhaled Corticosteroids 319 / 7824 (4.1%) 104 / 2511 (4.1%) 215 / 5313 (4.0%)
Systemic Corticosteroids 53 / 7824 (<1.0%) 22 / 2511 (<1.0%) 31 / 5313 (<1.0%)
Immunosuppressant Medications 161 / 7824 (2.1%) 67 / 2511 (2.7%) 94 / 5313 (1.8%)
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Table 15.1.4 Page 1of 1
BNT162b2 Protocol C4591008
Baseline Pregnancy / Baseline Vaccine History
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL
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Population1
(N = 7824)Primary Analysis Safety
Population2
(N = 2511)Consented but not in Primary
Analysis Safety Population
(N = 5313)
Were You Or Your Partner Pregnant At The Time Of Your First
COVID -19 Vaccine Dose?
Yes 253 / 6417 (3.9%) 101 / 2248 (4.5%) 152 / 4169 (3.6%)
Yes, I Was Pregnant 218 / 253 (86.2%) 83 / 101 (82.2%) 135 / 152 (88.8%)
Yes, My Partner Was Pregnant 35 / 253 (13.8%) 18 / 101 (17.8%) 17 / 152 (11.2%)
Other Than Your COVID -19 Vaccine, Did You Received Any
Vaccinations (e.g., Flu, Hepatitis) In The 6 Months Prior To Your First
COVID -19 Vaccine Dose?
Yes 5032 / 6417 (78.4%) 1823 / 2248 (81.1%) 3209 / 4169 (77.0%)
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Table 15.3.1.1 Page 1of 1
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine
Hospitalization is any hospitalization at any time during the study and after vaccination.
1: All Consented Population is defined as all enrolled participants.
2: Primary Analysis Safety Populatio n is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
3: A subject may have more than one hospitalization, so a hospitalization row count can be larger than the row particip ant count and the sum of hospitalization rows can be more
than the N in the header.
4: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
5: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
6: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
7: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP
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(N=7824)Primary Analysis Safety
Population2
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Hospitalizations3
NParticipants
n/N (%)Hospitalizations3
NParticipants
n/N (%)Hospitalizations3
N
Participants Reported Unplanned Hospitalization463 / 7824 (<1.0%) 68 16 / 2511 (<1.0%) 17 47 / 5313 (<1.0%) 51
Event Confirmation In Progress516 / 63 (25.4%) 18 2 / 16 (12.5%) 2 14 / 47 (29.8%) 16
Suspected Event631 / 63 (49.2%) 34 10 / 16 (62.5%) 11 21 / 47 (44.7%) 23
Probable Event716 / 63 (25.4%) 16 4 / 16 (25.0%) 4 12 / 47 (25.5%) 12
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Table 15.3.1.2 Page 1of 1
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Baseline
Vaccine Type -Pfizer
All Consented Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
All Consented Population is defined as all enr olled participants.
1: A subject may have more than one hospitalization, so a hospitalization row count can be larger than the row participant co unt and the sum of hospitalization rows can be more
than the N in the header.
2: Verily eCRF reported hospita lization collapsing on hospitalization date from the unplanned hospitalization forms.
3: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
4: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data : ADSL, ADHOSP
Generated from /dcri/ct/hero_together/tables/t_hosp_pfizer.sas on 24MAY2021 12:45 Page 14of 284 Enrolled withi n 10 days after
vaccine
(N=2511)Enrolled more than 10 days after
vaccine
(N=2888)Pfizer
(N=5399)
Participants
n/N (%)Hospitalizations1
NParticipants
n/N (%)Hospitalizations1
NParticipants
n/N (%)Hospitalizations1
N
Participants Reported Unplanned Hospitalization216 / 2511 (<1.0%) 17 27 / 2888 (<1.0%) 29 43 / 5399 (<1.0%) 46
Event Confirmation In Progress32 / 16 (12.5%) 2 7 / 27 (25.9%) 8 9 / 43 (20.9%) 10
Suspected Event410 / 16 (62.5%) 11 12 / 27 (44.4%) 13 22 / 43 (51.2%) 24
Probable Event54 / 16 (25.0%) 4 8 / 27 (29.6%) 8 12 / 43 (27.9%) 12
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Table 15.3.1.3 Page 1of 1
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine by Baseline
Vaccine Type -Other COVID -19 Vaccine
All Consented Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
All Consented Population is defined as all enrolled participants.
1: A subject may have more than one hospitalization, so a hospitalizatio n row count can be larger than the row participant count and the sum of hospitalization rows can be more
than the N in the header.
2: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
3: Hos pitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
4: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP
Generated from /dcri/ct/hero_together/tables/t_hosp_other.sas on 24MAY2021 12:45 Page 15of 284 Enrolled within 10 days after
vaccine
(N=835)Enrolled more than 10 days after
vaccine
(N=1590)Other COVID -19
vaccine
(N=2425)
Participants
n/N (%)Hospitalizations1
NParticipants
n/N (%)Hospitalizations1
NParticipants
n/N (%)Hospitalizations1
N
Participants Reported Unplanned Hospitalization22 / 835 (<1.0%) 2 18 / 1590 (1.1%) 20 20 / 2425 (<1.0%) 22
Event Confirmation In Progress31 / 2 (50.0%) 1 6 / 18 (33.3%) 7 7 / 20 (35.0%) 8
Suspected Event41 / 2 (50.0%) 1 8 / 18 (44.4%) 9 9 / 20 (45.0%) 10
Probable Event50 0 4 / 18 (22.2%) 4 4 / 20 (20.0%) 4
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Table 15.3.1.4 Page 1of 1
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Baseline
Pregnancy
Primary Analysis Safety Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: Pregnancy at time of enrolment includes both the participant and the partner pregnancy. There are 263 participants without preg nancy status due to no status being collected.
2: A subject may have more than one hospitalization, so a hospitalization row count can be larger than the row participant co unt and the sum of hospitalization rows can be more
than the N in the header.
3: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
4: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
6: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data : ADSL, ADHOSP
Generated from /dcri/ct/hero_together/tables/t_hosp_preg.sas on 24MAY2021 12:45 Page 16of 284 Pregnancy1
(N=101)Not Pregnancy
(N=2147)Primary Analysis Safety Population
(N=2511)
Participants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
N
Participants Reported Unplanned Hospitalization36 / 101 (5.9%) 6 10 / 2147 (<1.0%) 11 16 / 2511 (<1.0%) 17
Event Confirmation In Progress41 / 6 (16.7%) 1 1 / 10 (10.0%) 1 2 / 16 (12.5%) 2
Suspected Event53 / 6 (50.0%) 3 7 / 10 (70.0%) 8 10 / 16 (62.5%) 11
Probable Event62 / 6 (33.3%) 2 2 / 10 (20.0%) 2 4 / 16 (25.0%) 4
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Table 15.3.1.5 Page 1of 2
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Baseline
Age Group
Primary Analysis Safety Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: Age is based on birth date and at 1st dose of COVID-19 vaccine date.
2: A subject may have more than one hospitalization, so a hos pitalization row count can be larger than the row participant count and the sum of hospitalization rows can be more
than the N in the header.
3: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization for ms.
4: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
6: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP
Generated from /dcri/ct/hero_together/tables/t_hosp_age.sas on 24MAY2021 12:45 Page 17of 284 18-291
(N=282)30-391
(N=915)40-491
(N=657)Primary Analysis Safety Population
(N=2511)
Participants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
N
Participants
Reported
Unplanned
Hospitalization31 / 282 (<1.0%) 2 7 / 915 (<1.0%) 7 5 / 657 (<1.0%) 5 16 / 2511 (<1.0%) 17
Event
Confirmation In
Progress40 0 1 / 7 (14.3%) 1 1 / 5 (20.0%) 1 2 / 16 (12.5%) 2
Suspected
Event51 / 1 (100%) 2 4 / 7 (57.1%) 4 3 / 5 (60.0%) 3 10 / 16 (62.5%) 11
Probable Event60 0 2 / 7 (28.6%) 2 1 / 5 (20.0%) 1 4 / 16 (25.0%) 4
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Table 15.3.1.5 Page 2of 2
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Baseline
Age Group
Primary Analysis Safety Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: Age is based on birth date and at 1st dose of COVID-19 vaccine date.
2: A subject may have more than one hospitalization, so a hos pitalization row count can be larger than the row participant count and the sum of hospitalization rows can be more
than the N in the header.
3: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization for ms.
4: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
6: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP
Generated from /dcri/ct/hero_together/tables/t_hosp_age.sas on 24MAY2021 12:45 Page 18of 284 50-591
(N=439)60-691
(N=197)70 and above1
(N=21)Primary Analysis Safety Population
(N=2511)
Participants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
N
Participants
Reported
Unplanned
Hospitalization33 / 439 (<1.0%) 3 0 0 0 0 16 / 2511 (<1.0%) 17
Event
Confirmation In
Progress40 0 0 0 0 0 2 / 16 (12.5%) 2
Suspected
Event52 / 3 (66.7%) 2 0 0 0 0 10 / 16 (62.5%) 11
Probable Event61 / 3 (33.3%) 1 0 0 0 0 4 / 16 (25.0%) 4
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Table 15.3.1.6 Page 1of 1
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Baseline
Immunocompromised Status
Primary Analysis Safety Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
Primary Analysis Safety Populatio n is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: Immunocompromised status= Yes is defined based on a) having organ transplant or HIV/AIDS from baseline medical histo ry and b) taking any inhaled corticosteroids,
systemic corticosteroids, or immunosuppressant medications.
2: A subject may have more than one hospitalization, so a hospitalization row count can be larger than the row participant co unt and the sum of hospi talization rows can be more
than the N in the header.
3: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
4: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
6: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY 2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP
Generated from /dcri/ct/hero_together/tables/t_hosp_immun.sas on 24MAY2021 12:45 Page 19of 284 Yes1
(N=181)No
(N=2330)Primary Analysis Safety Population
(N=2511)
Participants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
NParticipants
n/N (%)Hospitalizations2
N
Participants Reported Unplanned Hospitalization31 / 181 (<1.0%) 2 15 / 2330 (<1.0%) 15 16 / 2511 (<1.0%) 17
Event Confirmation In Progress40 0 2 / 15 (13.3%) 2 2 / 16 (12.5%) 2
Suspected Event51 / 1 (100%) 2 9 / 15 (60.0%) 9 10 / 16 (62.5%) 11
Probable Event60 0 4 / 15 (26.7%) 4 4 / 16 (25.0%) 4
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Table 15.3.1.7 Page 1of 1
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization Anytime After Receipt of at Least 1 Dose of Pfizer COVID -19 Vaccine by
Dose Status
Primary Analysis Safety Population
Hospitalization is any hospitalization at any time during the study and after vaccination.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: Participants who took 2 doses of vaccine.
2: A s ubject may have more than one hospitalization, so a hospitalization row count can be larger than the row participant count an d the sum of hospitalization rows can be more
than the N in the header.
3: Verily eCRF reported hospitalization collapsing on hosp italization date from the unplanned hospitalization forms.
4: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "No".
6: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Yes".
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP
Generated from /dcri/ct/hero_together/t ables/t_hosp_doses.sas on 24MAY2021 12:45 Page 20of 284 2 Doses1
(N=2201)1 Dose Only
(N=310)Primary Anal ysis Safety Population
(N=2511)
Participants
n/N (%)Hospitalization2
NParticipants
n/N (%)Hospitalization2
NParticipants
n/N (%)Hospitalization2
N
Participants Reported Unplanned Hospitalization316 / 2201 (<1.0%) 17 0 0 16 / 2511 (<1.0%) 17
Event Confirmation In Progress62 / 16 (12.5%) 2 0 0 2 / 16 (12.5%) 2
Suspected Event710 / 16 (62.5%) 11 0 0 10 / 16 (62.5%) 11
Probable Event84 / 16 (25.0%) 4 0 0 4 / 16 (25.0%) 4
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Table 15.3.2.1.1 Page 1of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 21of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Any Adverse Event of Special Interest2928 / 7824 (11.9%) 1107 320 / 2511 (12.7%) 378 608 / 5313 (11.4%) 729
Hospitalized363 / 7824 (<1.0%) 84 16 / 2511 (<1.0%) 17 47 / 5313 (<1.0%) 67
Event Confirmation In Progress416 / 63 (25.4%) 30 2 / 16 (12.5%) 2 14 / 47 (29.8%) 28
Suspected Event (Unknown)522 / 63 (34.9%) 28 6 / 16 (37.5%) 7 16 / 47 (34.0%) 21
Suspected Event (Not Validated)623 / 63 (36.5%) 24 8 / 16 (50.0%) 8 15 / 47 (31.9%) 16
Probable Event72 / 63 (3.2%) 2 0 0 2 / 47 (4.3%) 2
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Table 15.3.2.1.1 Page 2of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 22of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Not Hospitalized8898 / 7824 (11.5%) 1023 313 / 2511 (12.5%) 361 585 / 5313 (11.0%) 662
Event Confirmation In Progress4666 / 898 (74.2%) 746 233 / 313 (74.4%) 261 433 / 585 (74.0%) 485
Suspected Event (Unknown)5161 / 898 (17.9%) 198 50 / 313 (16.0%) 66 111 / 585 (19.0%) 132
Suspected Event (Not Validated)662 / 898 (6.9%) 70 27 / 313 (8.6%) 31 35 / 585 (6.0%) 39
Probable Event79 / 898 (1.0%) 9 3 / 313 (1.0%) 3 6 / 585 (1.0%) 6
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Table 15.3.2.1.1 Page 3of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 23of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Brain Or Spinal Cord Inflammation (e.g.,
Meningitis, Encephalitis, Guillain -Barre
Syndrome)93 / 7824 (<1.0%) 4 0 0 3 / 5313 (<1.0%) 4
Event Confirmation In Progress42 / 3 (66.7%) 3 0 0 2 / 3 (66.7%) 3
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)61 / 3 (33.3%) 1 0 0 1 / 3 (33.3%) 1
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 4of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 24of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Severe Allergic Reaction (Anaphylaxis)914 / 7824 (<1.0%) 16 6 / 2511 (<1.0%) 7 8 / 5313 (<1.0%) 9
Event Confirmation In Progress44 / 14 (28.6%) 5 1 / 6 (16.7%) 1 3 / 8 (37.5%) 4
Suspected Event (Unknown)56 / 14 (42.9%) 7 4 / 6 (66.7%) 5 2 / 8 (25.0%) 2
Suspected Event (Not Validated)62 / 14 (14.3%) 2 1 / 6 (16.7%) 1 1 / 8 (12.5%) 1
Probable Event72 / 14 (14.3%) 2 0 0 2 / 8 (25.0%) 2
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Table 15.3.2.1.1 Page 5of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 25of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Non-Severe Allergic Reaction948 / 7824 (<1.0%) 52 15 / 2511 (<1.0%) 17 33 / 5313 (<1.0%) 35
Event Confirmation In Progress411 / 48 (22.9%) 13 1 / 15 (6.7%) 2 10 / 33 (30.3%) 11
Suspected Event (Unknown)531 / 48 (64.6%) 33 11 / 15 (73.3%) 12 20 / 33 (60.6%) 21
Suspected Event (Not Validated)65 / 48 (10.4%) 5 3 / 15 (20.0%) 3 2 / 33 (6.1%) 2
Probable Event71 / 48 (2.1%) 1 0 0 1 / 33 (3.0%) 1
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Table 15.3.2.1.1 Page 6of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 26of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Heart Inflammation (e.g., Myocarditis,
Pericarditis)93 / 7824 (<1.0%) 4 1 / 2511 (<1.0%) 1 2 / 5313 (<1.0%) 3
Event Confirmation In Progress40 1 0 0 0 1
Suspected Event (Unknown)53 / 3 (100%) 3 1 / 1 (100%) 1 2 / 2 (100%) 2
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 7of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 27of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Blood Clot Inside A Vein In The Body
(Thromboembolism)96 / 7824 (<1.0%) 6 0 0 6 / 5313 (<1.0%) 6
Event Confirmation In Progress41 / 6 (16.7%) 1 0 0 1 / 6 (16.7%) 1
Suspected Event (Unknown)54 / 6 (66.7%) 4 0 0 4 / 6 (66.7%) 4
Suspected Event (Not Validated)61 / 6 (16.7%) 1 0 0 1 / 6 (16.7%) 1
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 8of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 28of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Blood Vessel Inflammation (e.g., Kawasaki
Disease, Vasculitides)94 / 7824 (<1.0%) 4 2/ 2511 (<1.0%) 2 2 / 5313 (<1.0%) 2
Event Confirmation In Progress41 / 4 (25.0%) 1 0 0 1 / 2 (50.0%) 1
Suspected Event (Unknown)52 / 4 (50.0%) 2 1 / 2 (50.0%) 1 1 / 2 (50.0%) 1
Suspected Event (Not Validated)61 / 4 (25.0%) 1 1 / 2 (50.0%) 1 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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Table 15.3.2.1.1 Page 9of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 29of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Abnormal Blood Clotting (e.g., Disseminated
Intravascular Coagulation, Thrombocytopenia)93 / 7824 (<1.0%) 3 1 / 2511 (<1.0%) 1 2 / 5313 (<1.0%) 2
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)51 / 3 (33.3%) 1 0 0 1 / 2 (50.0%) 1
Suspected Event (Not Validated)61 / 3 (33.3%) 1 0 0 1 / 2 (50.0%) 1
Probable Event71 / 3 (33.3%) 1 1 / 1 (100%) 1 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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Table 15.3.2.1.1 Page 10of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 30of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Bleeding Disorder (Hemorrhagic Disease)90 0 0 0 0 0
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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Table 15.3.2.1.1 Page 11of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 31of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N(%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Heart Attack (Myocardial Infarction)92 / 7824 (<1.0%) 3 0 0 2 / 5313 (<1.0%) 3
Event Confirmation In Progress41 / 2 (50.0%) 2 0 0 1 / 2 (50.0%) 2
Suspected Event (Unknown)51/ 2 (50.0%) 1 0 0 1 / 2 (50.0%) 1
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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Table 15.3.2.1.1 Page 12of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 32of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Heart Failure/Cardiogenic Shock91 / 7824 (<1.0%) 1 0 0 1 / 5313 (<1.0%) 1
Event Confirmation In Progress41 / 1 (100%) 1 0 0 1 / 1 (100%) 1
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
Page 76
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Table 15.3.2.1.1 Page 13of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 33of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Stress Cardiomyopathy91 / 7824 (<1.0%) 1 0 0 1 / 5313 (<1.0%) 1
Event Confirmation In Progress41 / 1 (100%) 1 0 0 1 / 1 (100%) 1
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
Page 77
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Table 15.3.2.1.1 Page 14of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 34of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Coronary Artery Disease90 0 0 0 0 0
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
Page 78
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Table 15.3.2.1.1 Page 15of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 35of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Abnormal Heart Rhythm (Arrhythmia)91 / 7824 (<1.0%) 1 0 0 1 / 5313 (<1.0%) 1
Event Confirmation In Progress41 / 1 (100%) 1 0 0 1 / 1 (100%) 1
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
Page 79
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Table 15.3.2.1.1 Page 16of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 36of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Stroke Or Possible Stroke92 / 7824 (<1.0%) 3 1 / 2511 (<1.0%) 1 1 / 5313 (<1.0%) 2
Event Confirmation In Progress41 / 2 (50.0%) 1 1 / 1 (100%) 1 0 0
Suspected Event (Unknown)50 1 0 0 0 1
Suspected Event (Not Validated)61 / 2 (50.0%) 1 0 0 1 / 1 (100%) 1
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 17of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 37of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Blockage Of Blood Flow To Limbs (e.g., Limb
Ischemia, Peripheral Artery Disease)90 0 0 0 0 0
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 18of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 38of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Acute Kidney Injury90 0 0 0 0 0
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 19of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 39of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Liver Injury92 / 7824 (<1.0%) 2 0 0 2 / 5313 (<1.0%) 2
Event Confirmation In Progress41 / 2 (50.0%) 1 0 0 1 / 2 (50.0%) 1
Suspected Event (Unknown)51 / 2 (50.0%) 1 0 0 1 / 2 (50.0%) 1
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 20of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 40of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Skin Immune Reaction (e.g., Chillblain -Like
Lesions, Erythema Multiforme)90 0 0 0 0 0
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)50 0 0 0 0 0
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 21of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 41of 284 AllConsented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Multisystem Inflammation914 / 7824 (<1.0%) 15 2 / 2511 (<1.0%) 2 12 / 5313 (<1.0%) 13
Event Confirmation In Progress43 / 14 (21.4%) 3 0 0 3 / 12 (25.0%) 3
Suspected Event (Unknown)57 / 14 (50.0%) 8 0 0 7 / 12 (58.3%) 8
Suspected Event (Not Validated)64 / 14 (28.6%) 4 2 / 2 (100%) 2 2 / 12 (16.7%) 2
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 22of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 42of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Fibromyalgia95 / 7824 (<1.0%) 5 2 / 2511 (<1.0%) 2 3 / 5313 (<1.0%) 3
Event Confirmation In Progress42 / 5 (40.0%) 2 1 / 2 (50.0%) 1 1 / 3 (33.3%) 1
Suspected Event (Unknown)53 / 5 (60.0%) 3 1 / 2 (50.0%) 1 2 / 3 (66.7%) 2
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 23of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 43of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Nerve Inflammation Or Autoimmune Disease (e.g.,
Multiple Sclerosis, Rheumatoid Arthritis)924 / 7824 (<1.0%) 28 9 / 2511 (<1.0%) 11 15 / 5313 (<1.0%) 17
Event Confirmation In Progress47 / 24 (29.2%) 8 2 / 9 (22.2%) 2 5 / 15 (33.3%) 6
Suspected Event (Unknown)510 / 24 (41.7%) 12 4 / 9 (44.4%) 5 6 / 15 (40.0%) 7
Suspected Event (Not Validated)66 / 24 (25.0%) 7 3 / 9 (33.3%) 4 3 / 15 (20.0%) 3
Probable Event71 / 24 (4.2%) 1 0 0 1 / 15 (6.7%) 1
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Table 15.3.2.1.1 Page 24of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 44of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Autoimmune Thyroiditis94 / 7824 (<1.0%) 4 3 / 2511 (<1.0%) 3 1 / 5313 (<1.0%) 1
Event Confirmation In Progress41 / 4 (25.0%) 1 1 / 3 (33.3%) 1 0 0
Suspected Event (Unknown)53 / 4 (75.0%) 3 2 / 3 (66.7%) 2 1 / 1 (100%) 1
Suspected Event (Not Validated)60 0 0 0 0 0
Probable Event70 0 0 0 0 0
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Table 15.3.2.1.1 Page 25of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 45of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
COVID -19 Infection938 / 7824 (<1.0%) 52 15 / 2511 (<1.0%) 20 23 / 5313 (<1.0%) 32
Event Confirmation In Progress46 / 38 (15.8%) 10 3 / 15 (20.0%) 4 3 / 23 (13.0%) 6
Suspected Event (Unknown)518 / 38 (47.4%) 26 6 / 15 (40.0%) 10 12 / 23 (52.2%) 16
Suspected Event (Not Validated)610 / 38 (26.3%) 12 5 / 15 (33.3%) 5 5 / 23 (21.7%) 7
Probable Event74 / 38 (10.5%) 4 1 / 15 (6.7%) 1 3 / 23 (13.0%) 3
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Table 15.3.2.1.1 Page 26of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspected Event (Not Validated)".
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Probab le Event".
8: Verily eCRF reported adverse eve nts of special interest collapsing on seeking medical date for the same event from the other unplanned medical care forms
9: Adverse events of special interest collected from both unplanned hospitalization form and unplanned medical care form. If the event was reported on both form at the same
date, the event will be counted only once in the table.
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT
Generated from /dcri/ct/hero_together/tables/t_e vent.sas on 24MAY2021 12:44 Page 46of 284 All Consented
Population
(N=7824)Primary Analysis Safety
Population
(N=2511)Consented but not in Primary
Analysis Safety Population
(N=5313)
Participants
n/N (%)Events1
NParticipants
n/N (%)Events1
NParticipants
n/N (%)Events1
N
Generalized Convulsions/Seizures94 / 7824 (<1.0%) 5 1 / 2511 (<1.0%) 1 3 / 5313 (<1.0%) 4
Event Confirmation In Progress40 0 0 0 0 0
Suspected Event (Unknown)53 / 4 (75.0%) 4 0 0 3 / 3 (100%) 4
Suspected Event (Not Validated)61 / 4 (25.0%) 1 1 / 1 (100%) 1 0 0
Probable Event70 0 0 0 0 0
090177e1972655d4\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
Page 90
FDA-CBER-2021-5683-1075553
Table 15.3.2.1.1 Page 27of 33
BNT162b2 Protocol C4591008
Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine
All Consented Population is defined as all enrolled participants.
Primary Analysis Safety Population is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within 10 days of vaccination.
1: A subject may have more than one event, so an event row count can be larger than the row participant count and the sum of event rows can be more than the N in the header.
2: Excluding any events with hospitalization date or seeking medical date prior to vaccine date; if a p articipant reported an event on both hospitalization and unplanned medical
care form on the same date, the event will be counted only once as a Hospitalization.
3: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms. If more than one event was collected for
the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
4: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
5: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as "Suspec ted Event (Unknown)".
6: Adverse events of special interest with a link from the Verily eC
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