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Page 1of 69VERSION HISTORY
Version Effective Date Change Type
(New, Revise, Admin)Summary of Revisions
1.0 5 -4-2021 New New statistical analysis plan drafted
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Page 2of 69Non-Interventional Study Protocol
C4591008
HERO -Together: A post- Emergency Use Authorization observational cohort study to
evaluate the safety of the Pfizer -BioNTech COVID -19 vaccine in US healthcare workers ,
their families, and their communities
Interim Reporting Statistical Analysis Plan
(SAP)
Version : 1.0
Author : Merrill , Peter ;Shostak, Jack ;Wen, Jun;
Duke Clinical Research Institute
Date : 4 May 2021
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Page 3of 69TABLE OF CONTENTS
VERSION HISTORY ................................ ................................ ................................ .................. 1
LIST OF TABLES ................................ ................................ ................................ ..................... 7
LIST OF FIGURES ................................ ................................ ................................ ................... 7
1. AMENDMENTS FROM P REVI OUS VERSION(S) ................................ ........................... 8
2. INTRODUCTION ................................ ................................ ................................ ................. 8
2.1. Study Design ................................ ................................ ................................ ............. 8
2.2. Study Objectives ................................ ................................ ................................ .....14
3. INTERIM A NALYSES ................................ ................................ ................................ .......14
3.1. Disposition and retention ................................ ................................ ........................ 15
3.2. Demographic and baseline characteristics ................................ .............................. 15
3.3. Safet y Evaluations ................................ ................................ ................................ ...15
4. HYPOTHESES AND DECI SION RUL ES................................ ................................ ......... 16
5. ANALYSIS SETS/POP ULATIONS ................................ ................................ ................... 16
5.1. Full anal ysis set ................................ ................................ ................................ .......16
5.2. PRI MARY Anal ysis Safety set ................................ ................................ ............... 16
5.3. Other anal ysis sets ................................ ................................ ................................ ...16
5.4. Subgroups ................................ ................................ ................................ ................ 16
6. ENDPOINTS AND COV ARIATES ................................ ................................ ................... 17
6.1. Efficacy /Effectiveness Endpoint(s) ................................ ................................ ......... 17
6.2. Safet y Endpoints ................................ ................................ ................................ .....17
6.3. Other Endpoints ................................ ................................ ................................ .......17
6.4. Covariates ................................ ................................ ................................ ................ 17
7. HANDLING OF MI SSING VALUES ................................ ................................ ................ 20
8. STATI STICAL METHODOLO GY AND STATI STICAL A NALYSES .......................... 20
8.1. Statistical methods ................................ ................................ ................................ ...20
8.2. Statistical Analy ses................................ ................................ ................................ .20
8.2.1. Safet y Anal yses................................ ................................ .......................... 20
9. LIST OF TABLES AND TABLE SH ELLS................................ ................................ ........ 21
9.1. Section 1. Disposition and Retention ................................ ................................ ......21
Table 15.5.1 Disposition and Retention ................................ ............................... 22
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Page 4of 69Figure 15.5.1.1 Cumulative Rate of Study Discontinuation – All Consented
Population1................................ ................................ ................................ .......24
Figure 15.5.1.2 Cumulative Rate of Study Discontinuation – Primary
Analy sis Safet y Population1................................ ................................ ............. 25
Table 15.5.2 Visit Completion............................................................................26
9.2. Section 2. Demographic and Baseline Characteristics................................ ............ 27
Table 15.1.1 Baseline Demographics ................................ ................................ ...28
Table 15.1.2.1 Baseline Medical History (Participant Reported)......................... 30
Table 15.1.2.2 Baseline Medical Hi story Stratified by Pfizer vs Non- Pfizer
Vaccine (Participant Reported) and By Enrolment Within 10 Day s ............... 32
Table 15.1.3 Baseline Medications ................................ ................................ .......34
Table 15.1.4 Baseline Pregnancy / Baseline Vaccine History..............................35
9.3. Section 3. Safety Evaluations ................................ ................................ .................. 36
Table 15.3.1.1 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine ................................ 37
Table 15.3.1.2 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Vaccine Ty pe –Pfizer ................................ ................................ ...................... 38
Table 15.3.1.3 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Vaccine Ty pe –Other Covid- 19 Vaccine ................................ ........................ 39
Table 15.3.1.4 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Pregnancy ................................ ................................ ................................ ......... 40
Table 15.3.1.5 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Age Group ................................ ................................ ................................ ........ 41
Table 15.3.1.6 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Immunocompromi sed status ................................ ................................ ............ 43
Table 15.3.1.7 Participant Reported Unplanned Hospitalization1Anytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Dose Status .......44
Table 15.3.1.2.1 Adjudicated Hospitalization1Anyt ime After Receipt of at
Least 1 Dose of COVID -19 Vaccine ................................ ............................... 45
Table 15.3.1.2.2. Adjudicated Hospitalization1Anytime After Receipt of at
Least 1 Dose of COVID -19 Vaccineb y Vaccine Type – Pfizer ...................... 47
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Page 5of 69Table 15.3.1.2.3 Adjudicated Hospitalization1Anyt ime After Receipt of at
Least 1 Dose of COVID -19 Vaccineb y Vaccine Type – Other Covid-19
Vaccine ................................ ................................ ................................ ............ 48
Table 15.3.1.2.4 Adjudicated Hospitalization1Anyt ime After Receipt of at
Least 1 Dose of COVID -19 Vaccine b y Baseline Pregnancy .......................... 49
Table 15.3.1.2.5 Adjudicated Hospitalization Anytime After Receipt of at
Least 1 Dose of COVID -19 Vaccine b y Baseline Age Group ......................... 51
Table 15.3.1.2.6 Adjudicated Hospitalization Anytime After Receipt of at
Least 1 Dose of COVID -19 Vaccine b y Baseline Immunocompromi sed
status ................................ ................................ ................................ ................ 51
Table 15.3.1.2.7 Adjudicated Hospitalization Anytime After Receipt of at
Least 1 Dose of COVID -19 Vaccine b y Dose Status ................................ ......51
Table 15.3.2.1.1 Participants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose of COVI D-19 Vaccine ................. 52
Table 15.3.2.1.2 Participants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose o f COVID -19 Vaccine b y
Baseline Vaccine Ty pe –Pfizer ................................ ................................ .......54
Table 15.3.2.1.3 Participants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine b y
Baseline Vaccine Ty pe –Other Covid- 19 Vaccine ................................ ......... 56
Table 15.3.2.1.4 Par ticipants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine b y
Baseline Pregnancy ................................ ................................ .......................... 57
Table 15.3.2.1.5 Participants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine b y
Baseline Age group ................................ ................................ .......................... 59
Table 15.3.2.1.6 Participants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine b y
Baseline Immunocompromised I ndividuals ................................ .................... 59
Table 15.3.2.1.7 Participants Reported Adverse Events of Special Interest
Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine b y
Dose Status ................................ ................................ ................................ .......59
Table 15.3.2.2.1 Adjudicated Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine ................................ 60
Table 15.3.2.2.2 Adjudicated Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Vaccine
Type –Pfizer ................................ ................................ ................................ ....61
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Page 6of 69Table 15.3.2.2.3 Adjudicated Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Vaccine
Type –Other Covid- 19 Vaccine ................................ ................................ ......61
Table 15.3.2.2.4 Adjudicated Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Pregnancy ................................ ................................ ................................ ......... 62
Table 15.3.2.2.5 Adjudicated Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Age group ................................ ................................ ................................ ......... 63
Table 15.3.2.2.6 Adjudicated Adverse Events of Special Interest Any time
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Baseline
Immunocompromised Individuals ................................ ................................ ...63
Table 15.3.2.2.7 Adjudicated Adverse Events of Special Interest An ytime
After Receipt of at Least 1 Dose of COVID -19 Vaccine b y Dose Status .......63
Table 15.3.3.1 Adjudicated Hospitalization / AESI following Dose 1 ................ 63
Table 15.3.3.2 Adjudic ated Hospitalization / AESI following Dose 1 by
Baseline Pregnancy ................................ ................................ .......................... 65
Table 15.3.3.3 Adjudicated Hospitalization /AESI following Dos e 1 b y
Baseline Age group ................................ ................................ .......................... 65
Table 15.3.3.4 Adjudicated Hospitalization following Dose 1 b y Baseline
Immunocompromised Individuals ................................ ................................ ...65
9.4. Section 4. L istings ................................ ................................ ................................ ...66
Listing 7.7.1. Withdrawn Subjects ................................ ................................ .......67
Listing 7.7.2. Participant Reported Death ................................ ............................ 67
Listing 7.7.3. Subjects Excluded from the Anal ysis................................ ............. 67
Listing 7.7.4. Demographic Data ................................ ................................ .......... 67
Listing 7.7.5. Medication/Treatment Data ................................ ............................ 67
Listing 7.7.6. Participant reported Unplanned Hospitalization ............................ 68
Listing 7.7.7. Participant reported Non -Hospitalization Medical Events............. 68
10. REFERENCES ................................ ................................ ................................ .................. 69
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Page 7of 69LIST OF TABLES
Table 1. HERO-Together Schedule of Assessments ................................ .............. 12
Table 2. Safety Events of Interest ................................ ................................ ........... 17
LIST OF FIGURES
Figure 1. Overall Study Design ................................ ................................ ................ 11
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Page 8of 691.AMENDMENTS FROM PREVIOUS VERSION(S)
Not Applicable.
2.INTRODUCTION
Note: in this document ,any text taken directly from the non-interventional (NI) study
protocol is italicised .
In December 2019, a viral pneumonia outbreak of unknown origin was identified in W uhan,
China.1By January 2020, the outbreak was confirme d to be caused by a novel coronavirus
named severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2).2The outbreak
quickly reached pandemic levels, spreading to 213 countries and territories worldwide. In
February 2020, the World Health Organization formally named the disease caused by
SARS- CoV-2 the coronavirus disease 2019 (COVID- 19).3As of October 2, 2020, a total of
34.6 million confirmed cases and over 1 million deaths related to COVID -19 have been
reported.4Healthcare workers have been disproportionately affected by the pandemic, with
an infection risk 11 times that of the general population.5Due to this increased risk, the
National Academies of Science, Engineering, and Medicine has prioritized healthcare
workers for early receipt of vaccines to prevent SARS- CoV-2 infection.6
Given the public health emergency caused by the virus, Pfizer- BioNTech was granted
authorization of emergency use of their COVID -19 vaccine by the Food and D rug
Administration on 11 December 2020, prior to full approval of the biologic license
application (BLA) for the prevention of Coronavirus Disease 2019 (COVID -19) for
individuals 16 years of age and older. Detailed distribution plans for the COVID- 19 vacci ne
within the US are 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 early real- world safety i nformation on a
cohort of vaccinated health worker s, their families, and their communities for two years after
vaccination.
This document will outline the statistical anal ysis plan for the interim reporting for the
HERO- TOGETHER study . The interim anal ysis will be descriptive. The final anal yseswill
include comparative analysis and will be described in detail in a separate Final Analy sis SAP
prior to conduct of anal yses.
2.1.Study Design
HERO-TOGETHER is a prospective, observational cohort study of the incidence rates of
adverse events of special interest (AESI) and other clinically significant events within a
cohort of healthcare workers (HCWs), their families, and their communities who receive a
coronavirus disease 2019 (COVID -19) vaccine in the United States. Enrolment began 17
December 2020. Approximately 20,000 vaccinated HCWs will be enrolled and followed for
up to 24 months over a 30 -month study period. From the time of the first dose of the vaccine,
follow -up time points are at 1 wee k, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and then at 6, 9,
12, 18, and 24 months. Participants will be followed from date of enrolment until the end of
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Page 9of 69the 24-month period following first vaccine dose (index date) , end of the study period, death,
loss- to-follow up, or discontinuation from study .Participants must enrol within 60 day s of
vaccination and inclusion into the Primary Analy sis Safety population will be restricted to
those that enrol within 10 day s of first vaccine dose.
Study population
The study will enrol approximately self-selected, self -enrolled 20,000 US -based vaccinated
healthcare workers, their families, and their communities . Receipt of a vaccine to prevent
COVID -19 is required for inclusion in the study , but the decision to be vaccinated i s made at
the discretion of the recipient.
Study participants will be primaril y recruited from three sources:
An existing registry study , the Healthcare Worker Exposure Response and Outcomes
(HERO) Registry Study , which was launched in April 2020 to characterize COVID -19
risk factors and outcomes among US healthcare workers b y the Duke Clinical Research
Institute (DCRI).
TheProject Baseline Community Study platform operated b y Veril y. This study was
launched in April 2019 by Verily Life Sciences and provides an opportunity to acquire,
organize, anal yze, and activate phenoty pic data for a group of participants over time.
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. Once receiving s ystems are identified, study navigators will be identified
for vaccination sites within systems and activated to ensure broad geographic diversity in
the study .
Inclusion and Exclusion Criteria
Participants must be one of the following:
1. A healthcare worker (individual currently working in a setting where individuals
receive healthcare in the US including emergency medical services);
OR
2. Part of a family to which healthcare workers may also belong
OR
3. Anyone in the surrounding community
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Page 10of 69Participants must also be all of the following:
Age ≥18 years.
Able to speak and read English or Spanish.
Receipt of the first dose of a C OVID-19 vaccine for prevention of SARS- CoV-2
infection wi thin the past 60 days.
Evidence of informed consent indicating that the participant (or a legally acceptable
representative) has been informed of all pertinent aspects of the study.
There are no exclusion criteria for this study. All participants meeting inclusion criteria will
be eligible for analysis.
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Page 11of 69Figure 1.Overall Study Design
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Page 12of 69Data source s
Data for the study will be collected from several different sources described below.
Participant self -report
Participants will use an online portal to report a variety of data. Data in the self-reporting
forms contain information on demographic, medications, medical history , COVID -19
diagnosis, and follow -upvisits .Participants will also report hospitalizations and AESIs that
did not result in hospitalization for adjudication. I ndividuals with more than a 2- day interval
between vaccination and enrolment will be administered a retros pective assessment to
capture self -reported safety information occurring within this interval. Table 1 below
presents the planned schedule of assessments.
DCRI Call Center
The DCRI Call Center will follow -up on non -responsive participants and request medical
records for participants reporting hospitalization or diagnosis of an AESI according to a
predetermined schedule outlined in the Call Center Project Management Plan .
Clinical Events Ascertainment (CEA)
When a nAESI is reported, the CEA committee will use collected medical records to make a
determination of whether the event occurred. The CEA will also pr ovide an adjudicated event
date. This process, the timelines and the AESI definitions will be documented in the CEA
charter. When necessary , the CEA committee will also provide data regarding the status of
patient reported events undergoing the adjudication process as well as the patient reported
events that cannot be adjud icated.
HERO registry
All participants in HERO -TOGETHER are required to be enrolled in the parent HERO
registry . Data from the HERO registry for participants in HERO -TOGETHER may be used to
supplement the data collected by the study . Additionally , data about HCWs in the HERO
registry that are not participating in the study may be used to provide context as a comparison
group.
Table 1. HERO -Together Schedule of Assessments
Enrolment
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
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Page 13of 69Table 1. HERO -Together Schedule of Assessments
Enrolment
Data
CollectionFollow -up Data Collection
Vaccine Dose 1 information
Date
Lot number
SiteX
Vaccine Dose 2 information
Date
Lot number
SiteX
(and
subsequent
visits if
second
dose not
reported as
received )
Medical release 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 X X
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Page 14of 69Table 1. HERO -Together Schedule of Assessments
Enrolment
Data
CollectionFollow -up Data Collection
Health questionnaire
Potential safety events of
interest or clinically
significant events
Pregnancy statusX X X X X X X
2.2. Study Objectives
Primary Objective
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 EUA. (For the first interim report, incidence prop ortion will be measured.)
Secondary Objectives
Evaluate whether vaccine recipients experience increased risk of safety events of
interest and other clinically signi ficant events post -vaccination. (This objective is not
explored in interim reporting )
Estimate the incidence rates of safety events of interest and other clinically significant
events among subcohorts of interest such as pregnant women, immunocompromised
people, and stratified by age. (For the first interim report, incidence proportion will
be measured. )
3.INTERIM ANALYSES
Interim reports are scheduled for distribution 30 June 2021, 31 December 2021, 30 June
2022, and 31 December 2022. The interim reports will include subject disposition and
retention, vaccination information, demographic and baseline characteristics, vaccination
second dose status .There are no plans for an y formal stopping rules based on the results in
interim reporting.
Vaccination ,baseline characteristics and AESIs will be summarized using descriptive
statistics, including measures of central tendency and dispersion (means, medians, standard
deviations) for continuous variables . Categorical variables will be summarized by counts and
perce ntages.
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Page 15of 693.1.Disposition and retention
The count of subjects enrolled will be reported . Additio nal disposition reports will contain
the count of subjects enrolled , count of subjects completing each followup timepoint, number
who withdrew consent or discontinued from study early, number lost to follow -up, number of
death s, and number who have completed the study .
3.2.Demographic and baseline characteristics
Several demographic, medical history , and other baseline characteristics will be summarized
for the All Consented ( AC)and Primary Anal ysis Safety populations. These characteristics
will inclu de, but will not be limited to:
Age in y ears
Sex at birth
Race
Ethnicity
Occupation/emplo yment characteristics
Medical and surgical history
Select medications
Pregnancy
Influenza vaccination
Timing from initial COVID -19 vaccination dose to enrolment
COVID -19 vaccination second dose receipt and timing from ini tial dose
COVID -19 history
3.3.Safety Evaluations
The AESIs that will be evaluated in this study are listed in Table 2. Details for each AESI
will include reported hospitalizations,death , and confirma tion/adjudication status. This may
be refined as new information emerges. During follow -up time points, participants will
provide information on hospitalizations and diagnoses of AESI .
The count and incidence for each AESI will be calculated overall, and within subgroups of
interest .Data permitting, results may also be stratified by other baseline characteristics, such
as work setting and geog raphic region data permitting.
Generally , reporting of adjudicated events will be targeted for these safet y evaluations.
However, in the first interim report, adjudication results will not be available. In these
situations, participan t reports of AESI s will be included in the interim reporting. Incidence
rates will not be provided alongside participant -reported AESIs .Participant -reported AESIs
and outcomes will be categorized based on the status of the reported event in the
confirmation and adjudication process es.
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Page 16of 694.HYPOTHESES AND DECIS ION RULES
Interim anal yses are descriptive (see instructional test above for justification) . No
hypotheses will be evaluated.
5. ANALYSIS SETS/POPULATIONS
5.1.Full analysis set
The AC population is defined as all enrolled participants. The AC population will be used for
secondary analysesand safet y evaluations.
5.2.PRIMARY Analysis Safety set
The Primary Analysis Safety population is defined as all enrolled participants who received
the Pfizer -BioNTech COVID- 19 vaccine, as indicated on the baseline data collection form.
Additionally , the P rimary Analysis Safety population wi ll only include participants who
enrolled within 10 day s of the first dose of the vaccination to mitigate the risk of selective
enrolment and disproportionate representation of higher risk participants. The Primary
Analy sis Safet y population will be employ ed to investigate the primary objective of the
study .
5.3.Other analysis set s
The following subsets of the AC population will also be considered in certain reports
Consented but not in Primary Anal ysis Safet y Population: Participants that are
members of the AC population, but are not members of the Primary Anal ysisSafety
population , and the following subsets :
oParticipants that have received the Pfi zer-BioNTech COVID -19 vaccine who
enrolled after 10 day s of the first dose of the vaccination.
oParticipants that received a non- Pfizer vaccine and enrolled within 10 day s of
the first or only dose of the vaccination.
oParticipants that received a non- Pfizer vaccine and enrolled after 10 day s of
the first or only dose of the vaccination.
5.4.Subgroups
Tables will be prese nted overall and in the following subgroups :Pregnant women
(participant reported at enrolment )
Immunocompromised participants, defined as a participant who self reports at least
one of the following:
oMedical history of organ transplant
oMedical history of HIV/AIDS
oUse of inhaled or sy stemic corticosteroids
oUse of immunosuppressant medications
Categorical age groups ( at time of first vaccination)
o18-29years old
o30-39 years old
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Page 17of 69o40-49 years old
o50-59 years old
o60-69 years old
o70or more years old
Vaccine dosa ge groups
o1 dose group: participants who have received only one dose of a COVID -19
vaccine.
o2 dose group: participants who have received aplanned second dose of a
COVID -19 vaccine . This will be stratified by time frame between doses.
Note that it will be possible for participants initially in the 1 dose
group to enter into the 2 dose group if they receive their second dose
during the follow- up period.
6.ENDPOINTS AND COVARIATES
6.1.Efficacy/Effectiveness Endpoint(s)
Since the objectives of this study are centered on safet y, there are no planned efficacy
endpoints.
6.2.Safety Endpoints
Table 2 below contains a listing of the AESIs that serve as the endpoints of the study to
investigate safet y of the vaccine. AESI s will be self- reported b y stud y participants, and
adjudicated b y the CEA. The CEA charter contains the definitions for each AESI used to
confirm and adjudicate the event. Hospitalization for an AESI will also serve as a safet y
endpoint.
6.3.Other Endpoints
There are no other planned endpoints for this study.
6.4.Covariates
The planned anal yses for the interim reporting do not utilize any covariates.
Table 2.Safety Events of Interest
AESI
Neurologic:
Generalized convulsion/seizures
Guillain -Barre S yndrome
Aseptic meningitis
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Page 18of 69Table 2.Safety Events of Interest
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
COVID -19:
Severe COVID -19 disease *
Microangiopath y*
Heart failure and cardiogenic shock *
Stress cardiom yopath y*
Coronary artery disease *
Arry thmia *
Deep vein thrombosis
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Page 19of 69Table 2.Safety Events of Interest
Pulmonary embolus
Cerebrovascular stroke
Limb ischemia *
Hemorrhagic disease *
Acute kidney injury *
Liver injury
Chillblain -like lesions
Single organ cutaneous vasculitis *
Erythema multiforme *
Cardiac:
Myocarditis
Pericarditis
Acute m yocardial infarction
Hematologic:
Thrombocy topenia
Disseminated intravascular coagulation
Other:
Pregnancy outcomes
Death
Narcoleps y and cataplexy
Non-anaph ylactic allergic reactions
* Hospitalized manifestations only
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Page 20of 697.HANDLING OF MISSING VALUES
Missing data in interim reports will be noted for cleaning and improvements to data
collection , but there are no plans for imputation of missing data.
8.STATISTICAL METHODOLOGY AND STATIST ICAL ANALYSES
8.1.Statistical methods
8.1.1 Estimation of Incidence Proportion and Rates
Incidence proportions for hosp italizations, AESI s, and confirmed AESIs will be calculated as
the number of patient reported outcomes, and confirmed events divided by total population
throughout the follow -up period. Incidence proportions will be reported in the first interim
report. Incidence rates will be reported in future reports and will be described in a
respectivel y amended SAP.
Incidence rates for hospitalizations and AESI s, and confirmed AESIs will be calculated as
the number of patient reported outcomes, and confirmed events divided b y the total follow-
up time in the population. This basic formulation may be multiplied by a value as needed to
improve reporting and interpretation of the rates (i.e. presenting rates per 100 person -years).
Incidence rates will not be calc ulated in the first interim report , which will include only
participant -reported outcomes .
Index date for a participant’s follow -up time will be the date of the first dose of the vaccine.
Further description of dose 2 I R estimation will be detailed in sub sequent reports, but
presented descriptivel y in the first interim reports . Follow -up will end on the earliest of the
following dates: the date of the study 24 month follow -up, date of withdrawal from the study ,
date of loss to follow- up, date of death, or the date of the end of the study period.
8.2. Statistical Analyses
The planned anal yses for the interim reporting are described in detail in Section 3 of this
document. Anal yses for the final report will be described in a separate Final Analy sis SAP
8.2.1. Safety Analyses
Section 3.3 details the planned safety evaluations for the interim reporting. Analysis to
address the specific study objectives at the end of the study will be described in a separate
Final Anal ysis SAP.
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Page 21of 699.LIST OF TABLES AND TABLE SHELLS
9.1.Section 1. Disposition and Retention
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Page 22of 69Table 1 5.5.1 Disposition and Retention
All Consented
Population1
(N = xxx)Primary Analysis
Safety Population2
(N=xxx)Consented but not
in Primary
Analysis Safety
Population
(N=xxx)
Participants Enrolled Xx Xx Xx
Participants Completed the Study Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Participants A live and Remaining in the Stud y Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Days in the Study Since 1stVaccine3
N xx xx xx
Median (Q1, Q3) Xx (xx, xx) Xx (xx, xx) Xx (xx, xx)
Min, Max Xx, xx Xx, xx Xx, xx
Days Between 1stVaccine and Enrolment
N xx xx xx
Median (Q1, Q3) Xx (xx, xx) Xx (xx, xx) Xx (xx, xx)
Min, Max Xx, xx Xx, xx Xx, xx
Days Between 1st Vaccine and 2 ndVaccine3
N xx xx xx
Median (Q1, Q3) Xx (xx, xx) Xx (xx, xx) Xx (xx, xx)
Min, Max Xx, xx Xx, xx Xx, xx
Particip ants Who Did Not Complete the Study Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
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Page 23of 69All Consented
Population1
(N = xxx)Primary Analysis
Safety Population2
(N=xxx)Consented but not
in Primary
Analysis Safety
Population
(N=xxx)
Death Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Cause of Death related to COVID -19 Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Lost to Follow Up Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Withdr awal by Subject Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Study Terminated by Sponsor Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Other Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Reason for Withdrawal by Participants Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Technical Problems Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Too Time I ntensive Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Illness Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Non-compliance Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Safety Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Behavioral Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Administrative Reasons Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Other Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Note 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.
4: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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Page 24of 69Figure 15.5. 1.1 Cumulative Rate of Study Discontinuation –All Consented Population1
Note 1: All Consented population is defined as all enrolled participants.
2: Data as of DDMMMYYYY and generated from / path/programname.sas on DDMMMYYYY HH:MM
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Page 25of 69Figure 15.5.1. 2Cumulative Rate of Study Discontinuation –Primary Analysis Safety Population1
Repeat Figure 15.5.1.1 for Primary Analysis Safety population.
Note 1: Primary Analysis Safety population is defined as all enrolled participants who received the Pfizer -BioNTech COVID-19
vaccine and enrolled within 10 day s of vaccination.
2: Data as of DDMMMYYYY and generated from / path/programname.sas on DDMMMYYYY HH:MM
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Page 26of 69Table 1 5.5.2 Visit Completion
Participants Completed Survey at All Consented Population1
(N = xxx)Primary Analysis Safety
Population2
(N=xxx)Consented but not in
Primary Analysis Safety
Population
(N=xxx)
Expected Completed Expected Completed Expected Completed
Week 1 xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%)
Week 2 xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%)
Week 4 xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%)
Week 8 xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%)
Week 12 xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%)
Month 6 xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%) xx(xx.x%) xx (xx.x%)
Month 9 xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%)
Month 12 xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%)
Month 18 xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%)
Month 24 xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%) xx (xx.x%)
Note 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 w ithin
10 days of vaccination.
3: Data as of DDMMMYYYY and generated from /path/p rogramname.sas on DDMMMYYYY HH:MM
4: As patients may enroll up to 60 days after vaccination, it is possible that not all patients may have been enrolled in wee k 1
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Page 27of 699.2.Section 2. Demographic and Baseline Characteristics
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Page 28of 69Table 15.1.1 Baseline Demographics
Participant Characteristics All Consented
Population1
(N = xxx)Primary Analysis Safety
Population2
(N=xxx)Consented but not in
Primary Analysis Safety
Population
(N=xxx)
Age at First Dose in Years
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
Age at First Dose in Years
18-29 Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
30-39 Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
40-49 Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
50-59 Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
60-69 Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
70 and above Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Sex
Female Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Male Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Undifferentiated Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Race
White Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Black or African American Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
American Indian or Alaska Native Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Asian Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
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Page 29of 69Participant Characteristics All Consented
Population1
(N = xxx)Primary Analysis Safety
Population2
(N=xxx)Consented but not in
Primary Analysis Safety
Population
(N=xxx)
Native Haw aiian or Other Pacific
IslanderXx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Multiple Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Not Reported Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Unknown Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Ethnicity
Hispanic or Latino Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Not Hispanic or Latino Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Not Repo rted Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Unknown Xx/xx (xx.x%) Xx/xx (xx.x%) Xx/xx (xx.x%)
Note 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: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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Page 30of 69Table 15.1.2.1 Baseline Medical History (Participant Reported)
All Consented
Population1
(N = xxx)Prim ary Analysis
Safety Population2
(N=xxx)Consented but not in
Prim ary Analysis
Safety P opulation
(N=xxx)
Hypertension (high blood pressure) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Diabetes mellitus Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Obesity/Overweight Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Prior heart attack Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Heart failure/cardiomyopathy Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Coronary artery disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Prior stroke or mini -stroke (TIA) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Peripheral arterial or vascular disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Chronic obstructive pulmonary disease (COPD) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Asthma Xx (xx.x%) Xx (xx.x% ) Xx (xx.x%)
Smoking Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Chronic kidney disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Cancer (localized) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Cancer (metastatic) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Lymphoma Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Leukemia Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Liver disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Peptic ulcer disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Connective tissue disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Autoimmune disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Organ transplant Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
HIV/AIDS Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Previous COVID -19 diagnosis Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
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Page 31of 69All Consented
Population1
(N = xxx)Prim ary Analysis
Safety Population2
(N=xxx)Consented but not in
Prim ary Analysis
Safety P opulation
(N=xxx)
Note 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: Data as of DDMMMYYYY and generated from /path/progr amname.sas on DDMMMYYYY HH:MM
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Page 32of 69Table 15.1.2.2 Baseline Medical History Stratified by Pfizer vs Non- Pfizer Vaccine (Participant Reported) and By Enrolment
Within 10 Days
Pfizer COVID 19 Vaccine
(N=xxx)Other COVID 19 Vaccine Manufacturer
Enrolled within 10
days after vaccine1Enrolled more than
10 days after
vaccineEnrolled within 10
days after vaccineEnrolled more
than 10 days after
vaccine
Hypertension (high blood pressure) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Diabetes mellitus Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Obesity/Overweight Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Prior heart attack Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Heart failure/cardiomyopathy Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Coronary artery disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Prior stroke or mini -stroke (TIA) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Peripheral arterial or vascular disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Chronic obstructive pulmonary disease (COPD) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Asthma Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Smoking Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Chronic kidney disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Cancer (localized) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Cancer (metastatic) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Lymphoma Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Leukemia Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Liver disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Peptic ulcer disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Connective tissue disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Autoimmune disease Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Organ transplant Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
HIV/AIDS Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Previous COVID -19 diagnosis Xx (xx.x%) Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
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Page 33of 69Pfizer COVID 19 Vaccine
(N=xxx)Other COVID 19 Vaccine Manufacturer
Enrolled within 10
days after vaccine1Enrolled more than
10 days after
vaccineEnrolled within 10
days after vaccineEnrolled more
than 10 days after
vaccine
Note 1 This is the Primary Analysis Safety population, which is defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and
enrolled w ithin 10 days of vaccination.
2: Data as of DDMMMYYYY and generated from /pa th/programname.sas on DDMMMYYYY HH:MM
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Page 34of 69Table 15.1.3 Baseline Medications
All Consented
Population1
(N = xxx)Primary Analysis
Safety Population2
(N=xxx)Consented but not
in Primary
Analysis Safety
Population
(N=xxx)
Participants with Any Medications Below Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Inhaled corticosteroids Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Systemic corticosteroids Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Immunosuppressant medications Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Note 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: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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Page 35of 69Table 15.1.4 Baseline Pregnancy / Baseline Vaccine History
All Consented
Population1
(N = xxx)Primary Analysis
Safety Population2
(N=xxx)Consented but not
in Primary
Analysis Safety
Population
(N=xxx)
Were you or your pa rtner pregnant At the time of y our firstst
COVID -19 vaccine dose ?
Yes Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Yes, I was pregnant Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Yes, my partner was pregnant Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Other than your COV ID-19 vaccine, did you received an y
vaccinations (e.g., flu, hepatitis) in the 6 months prior to y our
first COVID -19 vaccine dose ?
Yes Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Note 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: Data as of DDMMMYYYY and generated from /path/programname.sas on DD MMMYYYY HH:MM
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Page 36of 699.3.Section 3. Safety Evaluations
Note: Tables using adjudicated events will be revised once the adjudicated data are available.
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Page 37of 69Table 15.3.1.1 Participant Reported Unplanned Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine
All Consented Population2
(N = xxx)Primary Analysis Safety
Population3
(N=xxx)Consented but not in
Primary Analysis Safety
Population
(N=xxx)
Participants
N (% )Hospitalization s4
NParticipants
N (% )Hospitalization s
NParticipants
N (% )Hospitalization s
N
Participants Reported Unplanned Hospitalization5x (x x%) x x (x x%) x x (x x%) x
Event In Process6x (x x%) x x (x x%) x x (x x%) x
Suspected event7x (x x%) x x (x x%) x x (x x%) x
Probable event8x (x x%) x x (x x%) x x (x x%) x
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
2: All Consented population is defined as all enrolled participants.
3: 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.
4: A subject may have more than one hospitalization, so a hospitalization ro w count can be larger than the row participant count and the sum of
hospitalization rows can be more than the N in the header.
5: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
6: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
7: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “No”.
8: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Yes”.
9: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
090177e1974072ed\Approved\Approved On: 10-Jun-2021 01:13 (GMT)
FDA-CBER-2021-5683-1075843
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Page 38of 69Table 15.3.1.2Participant Reported Unplanned Hospitalization1Anytime After Receipt of at Leas t 1 Dose of COVID -19
Vaccine by Baseline Vaccine Type –Pfizer
All Consented Population2
Enrolled within 10 days
after vaccine
(N=xxx)Enrolled more than 10 days
after vaccine
(N=xxx)Total (N=xxx)
Participants
N (% )Hospitalization s3
NParticipants
N (% )Hospitalization s
NParticipants
N (% )Hospitalization s
N
Participants Reported Unplanned Hospitalization4x (x x%) x x (x x%) x x (x x%) x
Event In Process5x (x x%) x x (x x%) x x (x x%) x
Suspected event6x (x x%) x x (x x%) x x (x x%) x
Probable event7x (x x%) x x (x x%) x x (x x%) x
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
2: All Consented population is defined as all enrolled participants.
3: A subject may have more than one hospitalization, so a hospitalization 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.
4: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalizati on 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 w ith a link f rom the Verily eCRF to CEA spreadsheet with confirmation status as “Yes”.
8: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
090177e1974072ed\Approved\Approved On: 10-Jun-2021 01:13 (GMT)
FDA-CBER-2021-5683-1075844
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Page 39of 69Table 15.3.1.3Participant Reported Unplanned Hospitalization1Anytime After Receipt of at L east 1 Dose of COVID -19
Vaccine by Baseline Vaccine Type –Other Covid -19 Vaccine
All Consented Population2
Enrolled within 10 days
after vaccine
(N=xxx)Enrolled more than 10
days after vaccine
(N=xxx)Other Covid -19 Vaccine
(N=xxx)
Participants
N (% )Hospitalization s3
NParticipants
N (% )Hospitalization s
NParticipants
N (% )Hospitalization s
N
Participants Reported Unplanned Hospitalization4x (x x%) x x (x x%) x x (x.x%) x
Event In Process5x (x x%) x x (x x%) x x (x.x%) x
Suspected event ( Unknown )6x (x x%) x x (x x%) x x (x.x%) x
Probable event7x (x x%) x x (x x%) x x (x.x%) x
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
2: All Consented population is defined as all enrolled participants.
3: 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.
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: Hospitalizatio n 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”.
8: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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Page 40of 69Table 15.3.1.4Participant Reported Unplanned Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Baseline Pregnancy
Primary Analysis Safety Population2
Pregnancy3
(N = xxx)Not Pregnancy
(N = xxx)Primary Analysis Safety
Population2
(N = xxx)
Participants
N (% )Hospitalization s4
NParticipants
N (% )Hospitalization s
NParticipants
N (% )Hospitalization s
N
Participants Reported Unplanned Hospitalization5x (x x%) x x (x x%) x x (x x%) x
Event In Process6x (x x%) x x (x x%) x x (x x%) x
Suspected event (Unknown )7x (x x%) x x (x x%) x x (x x%) x
Probable event8x (x x%) x x (x x%) x x (x x%) x
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
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: Pregnancy at time of enrolment includes both the participant and the partner pregnancy.
4: 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.
5: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
6: Hospitalization in Verily eCRF, but no linkage in the CEA sp readsheet yet.
7: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “No”.
8: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Yes”.
9: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
090177e1974072ed\Approved\Approved On: 10-Jun-2021 01:13 (GMT)
FDA-CBER-2021-5683-1075846
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Page 41of 69Table 15.3.1.5Participant Reported Unplanned Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Baseline Age Group
Primary Analysis Safety Population2
18-29 3
(N = xxx)30-39
(N = xxx)40-49
(N = xxx)50-59
(N = xxx)60-69
(N = xxx)70and above
(N = xxx)Primary Analysis
Population ( Safe)2
(N = xxx)
Participa
nts
N (% )Hospitalizati
ons4
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
N
Participants
Reported
Unplanned
Hospitalizat
ion5x (x x%) X x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x.x%) x x (x x%) x
Event
In Process 6x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x.x%) x x (x x%) x
Suspected
event
(Unknown)
7x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x.x%) x x (x x%) x
Probable
event 8x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x x%) x x (x.x%) x x (x x%) x
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Page 42of 6918-29 3
(N = xxx)30-39
(N = xxx)40-49
(N = xxx)50-59
(N = xxx)60-69
(N = xxx)70and above
(N = xxx)Primary Analysis
Population ( Safe)2
(N = xxx)
Participa
nts
N (% )Hospitalizati
ons4
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
NParticipa
nts
N (% )Hospitalizat
ions
N
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
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: Age is based on birth date and at 1stdose of COVID- 19 vaccine date.
4: 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.
5: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
6: Self -reported Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
7: Hospitalization w ith a li nk from the Verily eCRF to CEA spreadsheet with confirmation status as “No”.
8: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Yes”.
9: Data as of DDMMMYYYY and generated from /path/pr ogramname.sas on DDMMMYYYY HH:MM
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FDA-CBER-2021-5683-1075848
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Page 43of 69Table 15.3.1.6Participant Reported Unplanned Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Baseline Immunocompromised status
Primary Analysis Safety Population2
Yes3
(N = xxx)No
(N = xxx)Primary Analysis Safety
Population2
(N = xxx)
Participants
N (% )Hospitalization s4
NParticipants
N (% )Hospitalization s
NParticipants
N (% )Hospitalization s
N
Participants Reported Unplanned Hospitalization5x (x x%) x x (x.x%) x x (x x%) x
Event In Process6x (x x%) x x (x.x%) x x (x x%) x
Suspected event (Unknown )7x (x x%) x x (x.x%) x x (x x%) x
Probable event8x (x x%) x x (x.x%) x x (x x%) x
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
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: Immunocompromised status= Yes is defined based on 1) having Organ transplant or HIV/AIDS from baseline medical history and 2) taking any
Inhaled corticosteroids, Systemic corticosteroids, or Immunosuppressant medications.
4: A subject ma y have more than one hospitalization, so a hospitalization 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.
5: Verily eCRF reported hospitalization collapsing on hos pitalization date from the unplanned hospitalization forms.
6: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
7: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “No”.
8: Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Yes”.
9: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
090177e1974072ed\Approved\Approved On: 10-Jun-2021 01:13 (GMT)
FDA-CBER-2021-5683-1075849
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Page 44of 69Table 15.3.1.7Participant Reported Unplanned Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Dose Status
Primary Analysis Safety Population2
2 Doses3
(N = xxx)1 Dose Only
(N = xxx)Primary Analysis Safety
Population2
(N = xxx)
Participants
N (% )Hospitalization s4
NParticipants
N (% )Hospitalization s
NParticipants
N (% )Hospitalization s
N
Participants Reported Unplanned Hospitalization5x (x x%) x x (x.x%) x x (x x%) x
Event In Process6x (x x%) x x (x.x%) x x (x x%) x
Suspected event (Unknown )7x (x x%) x x (x.x%) x x (x x%) x
Probable event8x (x x%) x x (x.x%) x x (x x%) x
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
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: Participants who took 2 doses of vaccine.
4: A subject may have more than on e hospitalization, so a hospitalization 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.
5: Verily eCRF reported hospitalization collapsing on hospitalization date from the unplanned hospitalization forms.
6: Hospitalization in Verily eCRF, but no linkage in the CEA spreadsheet yet.
7: Hospitalization with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “No”.
8:Hospitalization w ith a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Yes”.
9: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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FDA-CBER-2021-5683-1075850
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Page 45of 69Table 15.3.1.2.1Adjudicated Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine
[Not Applicable for June 2021 Delivery]
Participants with one or m ore event(s) All Consented
Population2
(N = xxx)Prim ary Analysis
Safety Population3
(N=xxx)Consented but not in
Prim ary Analysis
Safety P opulation
(N=xxx)
Any Hospitalization Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
# of hospitalizations per participant
1 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
2 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
…
Have you been discharged from the hospitalization for this condition? Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Yes Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
No Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Days between 1st dose Vaccine and 1stHospitalization
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
How many days were you hospitalized?
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
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Page 46of 69Participants with one or m ore event(s) All Consented
Population2
(N = xxx)Prim ary Analysis
Safety Population3
(N=xxx)Consented but not in
Prim ary Analysis
Safety P opulation
(N=xxx)
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
2: All Consented population is defined as all enrolled participants.
3: Primary Analysis Safety populationis defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled
within 10 days of vaccination.
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Page 47of 69Table 15.3.1.2.2. Adjudicated Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Vaccine
Type – Pfizer
[Not Applicable for June 2021 Delivery]
Participants with one or m ore event(s) Enrolled within 10
days after vaccine2
(N=xxx)Enrolled more than 10 days
after vaccine
(N=xxx)Pfizer
(N=xxx)
Any Hospitalization Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
# of hospitalizations per participant
1 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
2 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
…
Have you been discharged from the hospitalization for this condition? Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Yes Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
No Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Days between 1st dose Vaccine and 1stHospitalization
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
How many days were you hospitalized?
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
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.
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Page 48of 69Table 15.3.1.2.3 Adjudicated Hospitalization1Anytime After Receipt of at Least 1 D ose of COVID -19 Vaccine by Vaccine Type
–Other Covid -19 Vaccine
[Not Applicable for June 2021 Delivery]
Participants with one or m ore event(s) Enrolled within 10
days after vaccine
(N=xxx)Enrolled more than 10
days after vaccine
(N=xxx)Other Covid -19
Vaccine
(N=xxx)
Any Hospitalization Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
# of hospitalizations per participant
1 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
2 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
…
Have you been discharged from the hospitalization for this condition? Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Yes Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
No Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Days between 1st dose Vaccine and 1stHospitalization
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
How many days were you hospitalized?
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
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Page 49of 69Table 15.3.1.2.4 Adjudicated Hospitalization1Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Baseline
Pregnancy
Primary Analysis Safety Population
[Not Applicable for June 2021 Delivery] Participants
with one or m ore event(s)Pregnancy
(N = xxx)Not Pregnancy
(N = xxx)Prim ary Analysis Safety
Population2
(N = xxx)
Any Hospitalization Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
# of hospitalizations per participant
1 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
2 Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
…
Have you been discharged from the hospitalization for this
condition?Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Yes Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
No Xx (xx.x%) Xx (xx.x%) Xx (xx.x%)
Days between 1st dose Vaccine and 1stHospitalization
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
How many days were you hospitalized?
N xx xx xx
Mean (SD) xx.x(xx.xx) xx.x(xx.xx) xx.x(xx.xx)
Median (Q1, Q3) xx(xx, xx) xx(xx, xx) xx(xx, xx)
Min, Max Xx,xx Xx,xx Xx,xx
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Page 50of 69[Not Applicable for June 2021 Delivery] Participants
with one or m ore event(s)Pregnancy
(N = xxx)Not Pregnancy
(N = xxx)Prim ary Analysis Safety
Population2
(N = xxx)
Note 1: Hospitalization is any hospitalization at any time during the study and after vaccination
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.
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Page 51of 69Table 15.3.1.2.5 Adjudicated Hospitalization Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine by Baseline Age
Group
[Not Applicable for June 2021 Delivery]
Table 15.3.1.2.6 Adjudicated Hospitalization Anytime After Receipt of at Least 1 Dose of COVID -19 Vaccine by Baseline
Immunocompromised status
[Not Applicable for June 2021 Delivery]
Table 15.3.1.2.7 Adjudicated Hospitalization Anytime After Receipt of at Least 1 Dose of COVID- 19 Vaccine by Dose Status
[Not Applicable for June 2021 Delivery]
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Page 52of 69Table 15.3.2.1.1Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine
All Consente dPopulation1
(N = xxx)Primary Analysis Safety Population2
(N=xxx)Consented but not in Primary
Analysis Safety P opulation
(N=xxx)
Participants
N (% )Events3
nParticipants
N (% )Events
nParticipants
N (% )Events
n
Any Adverse Event of Special Interest4x (x.x%) x x (x x%) x x (x x%) x
Hospitalized5,6x (x.x%) x x (x x%) x x (x x%) x
Event In Process7x (x.x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x.x%) x x (x x%) x x (x x%) x
Suspected event (not validated)9x (x.x%) x x (x x%) x x (x x%) x
Probable event10x (x.x%) x x (x x%) x x (x x%) x
Not Hospitalized11x (x.x%) x x (x x%) x x (x x%) x
Event In Process7x (x.x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x.x%) x x (x x%) x x (x x%) x
Suspected event (not validated)9x (x.x%) x x (x x%) x x (x x%) x
Probable event10x (x.x%) x x (x x%) x x (x x%) x
Neurologic12x (x.x%) x x (x x%) x x (x x%) x
Event In Process7x (x.x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x.x%) x x (x x%) x x (x x%) x
Suspected event (not validated)9x (x.x%) x x (x x%) x x (x x%) x
Probable event10x (x.x%) x x (x x%) x x (x x%) x
Generalized convulsion/seizures12x (x.x%) x x (x x%) x x (x x%) x
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Page 53of 69All Consente dPopulation1
(N = xxx)Primary Analysis Safety Population2
(N=xxx)Consented but not in Primary
Analysis Safety P opulation
(N=xxx)
Participants
N (% )Events3
nParticipants
N (% )Events
nParticipants
N (% )Events
n
Event In Process7x (x.x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x.x%) x x (x x%) x x (x x%) x
Suspected event (not validated)9x (x.x%) x x (x x%) x x (x x%) x
Probable event10x (x.x%) x x (x x%) x x (x x%) x
… x (x.x%) x x (x x%) x x (x x%) x
Note 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 w ithin
10 days of vaccination.
3: 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.
4: Excluding any events w ith hospitalization date or seeking medical date prior to vaccine date; if a participant reported an event on both hospitalization
and unplanned medical care form on the same da te, the event w ill be counted only once as a Hospitalization.
5: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalizat ion forms.
6: If more than one event was collect ed for the same hospitalization, all events will have the same confirmation status on CEA spreadsheet.
7: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
8: Adverse events of special intere st with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Suspected event (unknown)”.
9: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Suspec ted event (not
validated)”.
10: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Proba ble event”.
11: Verily eCRF reported adverse events of special interest collapsing on seeki ng medical date for the same event from the other unplanned medical
care forms.
12: 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 t he same date, the event will be counted only once in the table.
13: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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Page 54of 69Table 15.3.2.1.2Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine by Baseline Vaccine Type –Pfizer
All Consented Population1
Enrolled within 10 days after
vaccine
(N=xxx)Enrolled more than 10 days
after vaccine
(N=xxx)Pfizer
(N=xxx)
Participants
N (%)Events2
nParticipants
N (%)Events
nParticipants
N (%)Events
n
Any Adverse Event of Special Interest3x (x x%) x x (x x%) x x (x x%) x
Hospitalized4,5x (x x%) x x (x x%) x x (x x%) x
Event In Process6x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)7x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )8x (x x%) x x (x x%) x x (x x%) x
Probable event9x (x x%) x x (x x%) x x (x x%) x
Not Hospitalized10x (x x%) x x (x x%) x x (x x%) x
Event In Process6x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)7x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )8x (x x%) x x (x x%) x x (x x%) x
Probable event9x (x x%) x x (x x%) x x (x x%) x
Neurologic11x (x x%) x x (x x%) x x (x x%) x
Event In Process6x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)7x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )8x (x x%) x x (x x%) x x (x x%) x
Probable event9x (x x%) x x (x x%) x x (x x%) x
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Page 55of 69Enrolled within 10 days after
vaccine
(N=xxx)Enrolled more than 10 days
after vaccine
(N=xxx)Pfizer
(N=xxx)
Participants
N (%)Events2
nParticipants
N (%)Events
nParticipants
N (%)Events
n
Generalized convulsion/seizures11x (x x%) x x (x x%) x x (x x%) x
Event In Process6x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)7x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )8x (x x%) x x (x x%) x x (x x%) x
Probable event9x (x x%) x x (x x%) x x (x x%) x
… x (x x%) x x (x x%) x x (x x%) x
Note 1: All Consented population is defined as all enrolled participants.
2: 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.
3: Excluding any events w ith hospitalization date or seeking medical date prior to vaccine date; if a participant rep orted an event on both hospitalization
and unplanned medical care form on the same date, the event w ill be counted only once as a Hospitalization.
4: Verily eCRF reported adverse events of special interest collapsing on hospitalization date from the unplanned hospitalization forms.
5: If more than one event was collected for the same hospitalization, all events will have the same confirmation status on CE A spreadsheet.
6: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
7: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Suspec ted event (unknown)”.
8: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Suspected event (not
validated)”.
9: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Probab le event”.
10: Verily eCRF reported adverse events of special interest collapsing on seeking medical date for the same event from the ot her unplanned medical
care forms.
11: Adverse events of special interest collected from both unplanned hospital ization 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.
12: Data as of DDMMMYYYY and generated from /path/programname.sas on DDMMMYYYY HH:MM
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Page 56of 69Table 15.3.2.1.3 Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine by Baseline Vaccine Type –Other Covid -19 Vaccine
All Consented Population
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Page 57of 69Table 15.3.2.1.4Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine by Baseline Pregnancy
Primary Analysis Safety Population1
Pregnancy2
(N=xxx)Not Pregnancy
(N=xxx)Primary Analysis Safety
Population1
(N=xxx)
Participants
N (%)Events3
nParticipants
N (%)Events
nParticipants
N (%)Events
n
Any Adverse Event of Special Interest4x (x x%) x x (x x%) x x (x x%) x
Hospitalized5,6x (x x%) x x (x x%) x x (x x%) x
Event In Process7x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )9x (x x%) x x (x x%) x x (x x%) x
Probable event10x (x x%) x x (x x%) x x (x x%) x
Not Hospitalized11x (x x%) x x (x x%) x x (x x%) x
Event In Process7x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )9x (x x%) x x (x x%) x x (x x%) x
Probable event10x (x x%) x x (x x%) x x (x x%) x
Neurologic12x (x x%) x x (x x%) x x (x x%) x
Event In Process7x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )9x (x x%) x x (x x%) x x (x x%) x
Probable event10x (x x%) x x (x x%) x x (x x%) x
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Page 58of 69Pregnancy2
(N=xxx)Not Pregnancy
(N=xxx)Primary Analysis Safety
Population1
(N=xxx)
Participants
N (%)Events3
nParticipants
N (%)Events
nParticipants
N (%)Events
n
Generalized convulsion/seizures12x (x x%) x x (x x%) x x (x x%) x
Event In Process7x (x x%) x x (x x%) x x (x x%) x
Suspected event (unknown)8x (x x%) x x (x x%) x x (x x%) x
Suspected event (not validated )9x (x x%) x x (x x%) x x (x x%) x
Probable event10x (x x%) x x (x x%) x x (x x%) x
… x (x x%) x x (x x%) x x (x x%) x
Note 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.
2: Pregnancy at time of enrolment includes both the participant and the partner pregnancy.
3: 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.
4: Excluding any events w ith hospitalization da te or seeking medical date prior to vaccine date; if a participant reported an event on both hospitalization
and unplanned medical care form on the same date, the event w ill be counted only once as a Hospitalization.
5: Verily eCRF reported adver se events of special interest collapsing on hospitalization date from the unplanned hospitalization forms.
6: If more than one event was collected for the same hospitalization, all events will have the same confirmation status on CE A spreadsheet .
7: Adverse events of special interest in Verily eCRF, but no linkage in the CEA spreadsheet yet.
8: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Suspec ted event ( unknown)”.
9: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Suspec ted event (not
validated)”.
10: Adverse events of special interest with a link from the Verily eCRF to CEA spreadsheet with confirmation status as “Probable event”.
11: Verily subject reported adverse events of special interest collapsing on seeking medical date for the same event from the other unplanned medical
care forms.
12: Adve rse 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. 13: Data as of DDMMMYYYY and generated from
/path/programname.sas on DDMMMYYYY HH:MM
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Page 59of 69Table 15.3.2.1.5Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine by Baseline Age group
Primary Analysis Safety Population
Table 15.3.2.1.6Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine by Baseline Immunocompromised Individuals
Primary Analysis Safety Population
Table 15.3.2.1.7Participants Reported Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-
19 Vaccine by Dose Status
Primary Analysis Safety Population
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Page 60of 69Table 15.3.2.2.1Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID-19
Vaccine
Primary Analysis Safety Population
[Not Applicable for June 2021 Delivery]
All Consented
Population1
(N = xxx)Primary Analysis Safety
Population2
(N=xxx)Consented but not in Primary
Analysis Safety population
(N=xxx)
Participants
N (%)Events
nParticipants
N (%)Participants
N (%)Events
nParticipants
N (%)
Any Adverse Event of Special Interest x (x.x%) x x (x x%) x x (x x%) x
Hospitalized x (x.x%) x x (x x%) x x (x x%) x
Not Hospitalized x (x.x%) x x (x x%) x x (x x%) x
Neurologic
Generalized convulsion/seizures x (x.x%) x x (x x%) x x (x x%) x
Guillain -Barre Syndrome x (x.x%) x x (x x%) x x (x x%) x
…
Note 1: All Consented population is defined as all enrolled participants.
2: Primary Analysis Safety populationis defined as all enrolled participants who received the Pfizer -BioNTech COVID -19 vaccine and enrolled within
10 days of vaccination.
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Page 61of 69Table 15.3.2.2 .2Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Vaccine Type – Pfizer
[Not Applicable for June 2021 Delivery]
Table 15.3.2.2.3Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Vaccine Type – Other Covid -19 Vaccine
[Not Applicable for June 2021 Delivery]
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Page 62of 69Table 15.3.2.2.4Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of C OVID -19
Vaccine by Baseline Pregnancy
Primary Analysis Safety Population
[Not Applicable for June 2021 Delivery]
Pregnancy
(N=xx)Not Pregnancy
(N=xx)Primary Analysis Safety
Population1
(N =xx)
Participant
ss
n (%)Events
nParticipant
s
n (%)Events
nParticipant
s
n (%)Events
n
Any Adverse Event of Special Interest x (x.x%) X #records x (x.x%) x x (x.x%) x
Hospitalized x (x.x%) X #records x (x.x%) x x (x.x%) x
Not Hospitalized x (x.x%) X #records x (x.x%) x x (x.x%) x
Neurologic
Generalized convulsion/seizures x (x.x%) x x (x.x%) x x (x.x%) x
Guillain -Barre Syndrome x (x.x%) x x (x.x%) x x (x.x%) x
…
Note 1: Primary Analysis Safety populationis defined as all enrolled participants who received the Pfizer -BioNTech COVID -19vaccine and enrolled within
10 days of vaccination.
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Page 63of 69Table 15.3.2.2.5Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Baseline Age group
[Not Applicable for June 2021 Delivery]
Table 15.3.2.2.6Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Baseline Immunocompromised Individuals
[Not Applicable for June 2021 Delivery]
Table 15.3.2.2.7Adjudicated Adverse Events of Special Interest Anytime After Receipt of at Least 1 Dose of COVID -19
Vaccine by Dose Status
Primary Analysis Safety Population
[Not Applicable for June 2021 Delivery]
Table 15.3.3.1 Adjudicated Hospitalization / AESI following Dose 1
Primary Analysis Safety Population
[Not Applicable for June 2021 Delivery]
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Page 64of 69Cases /
Surveillance Time per 1000 p -yrsPrimary Analysis Safety
Population1
(N=x xx)
Hospitalization Xx /x xxx
Death Xx /x xxx
Mean (Days since 1stVaccine)
Any AESI Xx /x xxx
Neurologic Xx /x xxx
Guillain -Barre Syndrome Xx /x xxx
….. Xx /x xxx
Note 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.
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Page 65of 69Table 15.3.3.2 Adjudicated Hospitalization / AESI following Dose 1 by Baseline Pregnancy
Primary Analysis Safety Population [Not Applicable for June 2021 Delivery]
Cases /
Surveillance Time per 1000 p -yrsPregnancy
(N=x xx) Not Pregnancy
(N=x xx) Primary Analysis
Safety Population1
(N=x xx)
Hospitalization Xx /x xxx Xx /x xxx Xx /x.xxx
Death Xx /x xxx Xx /x xxx Xx /x.xxx
Any AESI Xx /x xxx Xx /x xxx Xx /x.xxx
Neurologic Xx /x xxx Xx /x xxx Xx /x.xxx
Guillain -Barre Syndrome Xx /x xxx Xx /x xxx Xx /x.xxx
….. Xx /x xxx Xx /x xxx Xx /x.xxx
Note 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.
Table 15.3.3.3 Adjudicated Hospitalization /AESI following Dose 1 by Baseline Age group
[Not Applicable for June 2021 Delivery]
Table 15.3.3.4 Adjudicated Hospitalization following Dose 1 by Baseline Immunocompromised Indi viduals
[Not Applicable for June 2021 Delivery]
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Page 66of 699.4.Section 4. Listings
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Page 67of 69Listing 7.7.1 . Withdrawn Subjects
Subject ID Age/Sex/Race Date of Study Exit Reason for Non -Com pletion Withdrawal by Subject Reason
Listing 7.7.2 . Participant Reported Death
Subject ID Age/Sex/Race Vaccination Date Days since 1st Vaccine to Death Covid -19 Related
Listing 7.7.3 . Subjects Excluded from the Analysis
Subject ID Age/Sex/Race Exclusion Reason
Listing 7.7.4 . Demographic Data
Subject ID Age/Sex/Race Ethnicity
Listing 7.7.5 . Medication/Treatment Data
Subject ID Age/Sex/Race Dose Number Date of Dose Maufacturer Lot Number Injection Site Facility
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Page 68of 69Listing 7.7.6. Participant reported Unplanned Hospitalization
Subject ID Age/Sex/Race Vaccination Date Admission Date Days
HospitalizedCondition(s) Causing
hospitalization
Listing 7.7.7. Participant reported Non -Hospitalization Medical Events
Subject ID Age/Sex/Race Vaccination Date Reported Condition Onset Date What caused you to seek
medical care for this
condition
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Page 69of 6910.REFERENCES
1. WHO Novel coronavirus –China. Jan 12, 2020.
http://www.who.int/csr/don/12 -january -2020- novel- coronavirus -china/en/ .
2. Jiang S, Xia S, Ying T, Lu L . A novel coronavirus (2019 -nCoV) causing pneumonia -
associated respiratory syndrome. Cell Mol Immunol. 2020;17(5):554 .
3. World Health Organization. Naming the coronavirus disease (COVID -19) and the virus
that causes it. Accessed O ctober 2, 2020. Available:
https://www.who.int/emergencies/diseases/novel- coronavirus- 2019/technical-
guidance/naming -the-coronavirus- disease -(covid -2019)- and-the-virus -that-causes -it.
4. COVID -19 Dashboard by the Center for S ystems Science and Engineering (CSSE) at
Johns Hopkins University (JHU). https://coronavirus.jhu.edu/map.html .
5. Nguyen LH, Drew DA, Graham MS, et al. Risk of COVID- 19 among front -line health -
care workers and the general community : a prospective cohort study . Lancet Public
Health. 2020;5(9):e475- e483.
6. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable
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090177e1974072ed\Approved\Approved On: 10-Jun-2021 01:13 (GMT)
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