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Pfizer Inc.
235 East 42ndStreet
New York, NY 10017
Global Product Developm ent
29January2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl Center
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WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
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THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
REGISTRATION OF PRODUCTS FOR PFIZE R
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
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OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
SN0195
Re:Covid-19 Vaccine(BNT162/PF -07302048) BB-IND 19736
IND Amendment –Post-authorization Safety Studies: Study C4591008,
C4591011, C4591012 Protocols
Dear Dr. Gruber ,
Reference is made to BB-IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioN Tech are developing for the prevention of COVID -19 in adults ≥16
years of age. The IND was effective on April 29, 2020.
The present submission provides the final protocol for the three post-authorization
epidemiological safet y studies:
C4591008 entitled, “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 ”
C4591011 entitled, “ActiveSafety Surveillance of the Pfizer-BioNTech COVID -19
Vaccine in the U nited States Departme nt of Defense Population F ollowing
Emergency Use Authorization ”
C4591012 entitled, “Post-Emergency Use Authorization Active Surveillance Study
among Individuals in the Veteran ’sAffairs Health System Receiving Pfizer-BioNTech
Coronavirus Disease 2019 (COVID-19) Vaccine ”
Please note ,as explained in the Pharmacovigilence Plan , the milestone due dates associated
with these reports were contingent up on vaccine availability on 1 December 2020. However,
sincesupply was not available as of 1 December 2020 the interim reports based on a 31
FDA-CBER-2021-5683-1072483
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 29January2021
Pfizer Confid ential
Page 2March 2021 have been removed from the protocols. The first interim report will now be the
30 June 2021 report.
These protocols are being submitted to both BB -IND 19736 and EUA 27034 in parallel .
Shouldyou have any questions regarding t his submission,or require additionalinformation,
pleasecontact me via phone a t 212-733-2613; via facsimile at 845 -474-3500; or via e-mail at
[email protected] .
Sincerely,
Neda Aghajani Memar, Pharm.D.
SeniorManager, Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet
219/9/69
NewYork, NY 10017
CC: Ramac handra S. Naik, Ph.D.
FDA-CBER-2021-5683-1072484