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Non-Interventional Study Report Abstract
Protocol C4591008
PFIZER CONFIDENTIAL
Page 1NON- INTERVENTIONAL STUDY REPORT ABSTRACT
Title: A Post-Emergency Use Authorization Observational C ohort S tudy to Evaluate the
Safety of the Pfizer -BioNTech COVID-19 Vaccine in US Healthcare Workers, T heir
Families, and Their Communities
Date: 22June 2 021
Name and affiliation of the main author:
Emily O’Brien, PhD
Duke Clinical Research Institute
200 Morris Street
Durham, NC 27701
Keywords: COVID -19, vaccine, observational
Rationale and background: Pfizer -BioNTech COVID- 19 vaccine was approved f or
emergency use authorization (EUA) to prevent Coronavirus Disease 2019 (COVID- 19) for
individuals 16 y ears of age and older. Detailed distribution plans for the COVID- 19 vaccine
within the US are determined by local jurisdictions based on federal recomme ndations 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
cohort of vaccinated healthcare workers , their families, and t heir communities for two years
after vaccination. This non -interventional study is designated as a PASS and is included in
the US pharmacovigilance plan.
Research question and objectives: The research questions addressed by 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 and b) how do those rates c ompare
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 vaccinate dwith the Pfizer -BioNTech COVID -19 vaccine
following Emergency Use Authorization.
Secondary objectives
Evaluate whether vaccine recipients experience increased risk of safet y events of
interest and other clinically signi ficant 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 b y age.
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Non-Interventional Study Report Abstract
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Page 2Study design: This is a prospective observational cohort study of US healthcare workers,
their families, and their communities, in which data are collected from participant self -report
at regular intervals following vaccination, primarily using a secur e,participant- facing web
portal, as well as medical records for confirming the occurrence of safet y events. The study
period will be 30 months.
Setting: Participants will be recruited from three primary sources. The first is the Healthcare
Worker Expos ure 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 ). The second source of
participant sis from the Project Baseline Community Study platform operated by Veril y.
This study was launched in April 2019 by Verily Life Sciences and provides an opportunity
to acquire, organize, analy ze, and activate phenotypic data for a group of participants over
time. The third source of participants is major health sy stems distributing Pfizer -BioNTech
COVID -19 vaccine to its employ ees, their families, and community members as determined
by local jurisdictional EUA rollout plans.
Subjects and study size, inclu ding dropouts: This study will aim to enroll and follow
20,000 vaccinated healthcare workers, their families, and their communities during a 30 -
month study period. The data for this interim report was cut for subjects enrolling before 29
April 2021, which was just prior to a study expansion in order to include more than health
care workers.
Variables and data sources: The study will capture data through three primary mechanisms.
First, participants will use a secure ,participant -facing web -portal to provi de information on
COVID -19 vaccination, baseline characteristics, seeking of non- routine medical care
(including hospitalization) and potential occurrence of safet y events of interest. Secondl y, a
Call Center will be utilized to:
Serve as a “rescue” mechan ism to minimize incomplete data from non -response and
loss to follow -up, and
Request medical records for confirmation of the occurrence of safet y events of
interest.
This report summarizes participant -reported outcomes thatare confirmed via medical record
review b y the DCRI Clinical Events Ascertainment CEA Confirmation Team . The full
adjudication process is being finalized. In the interim, the CEA confirmation team has
implemented a confirmation process whereb y available medical records are reviewed to
determine probable event status for further details). Full adjudication of events will be
reported in future reports, after the adjudication process finalization.
Results: This interim report includes a d escriptive anal ysis andparticipant -reported
outcom es using data collected from 17 December 2020 through 29 April 2021 . Of the 7824
consented participants ,2511 were eligible for inclusion in the primary analysis safety
population (PASP) and 5 313 were in the consented but not eligible for inclusion in the
primary anal ysis safet y population (CNPASP) . Thedistribution of demographic
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Non-Interventional Study Report Abstract
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Page 3characteristics, baseline characteristics, study withdrawals , medical history , and baseline
medication use were similar between these populations . The PASP is primarily white
(79.1%), female (70.3%), and not Hispanic (82.0%).
The incidence proportions of reported h ospitalization swere numericall y similar for the PASP
and all consented population (ACP) . In general, the proportion of the PASP r eporting an y
safet y event of interest w as numericall y similar to that of the ACP . Two deaths were reported
(one in the PASP and one in the CNPASP); n either was COVID -19 related.
Immunocompromised participants in the PASP r eported more frequentl y any safet y event of
interest (21.5%) than non- immunocompromised participants (12.1%).
Discussion: Of the initial 7824 participants enrolled in HERO- Together, population
demographics are consistent with expected distributions given the healthcare worker
inclusion criterion at the time of this data cut, the online nature of the stud y and the
requirement for vaccination prior to enrollment.2While the inclusion criteria for HERO -
Together are intentionally broad, racial/ethnic diversity of the initial population is lower than
anticipated, with the majority of participants identify ing as white. The number of participant-
reported events to date was low for most pre -specified AESIs, and the majority of events
were still in the process of full adjudication. Therefore, all AESIs in this report should be
interpret ed with caution. Source documentation will be requested for these events to
determine occurrence of any AESIs consistent with study definitions.
Names and affiliations of principal investigators:
Name, d egree(s) Job Title Affiliation Address
Emily O’Brie n, 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 Sr. Director, Global
Medical EpidemiologyPfizer Inc. 235 E 42ndSt,
New York, NY 10017
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