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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
30June 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AN D/OR
REG ISTRATION OF PRODUCTS FOR PFIZER
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
USED, IN WHOLE OR IN PART, FOR ANY
OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
SN0386
Re: Covid-19 Vaccine (BNT162/PF -07302048) BB- IND 19736
IND Amendment –Non-Interventional Study Interim Report for Study
C4591008 and C4591012
Dear Dr. Gruber ,
Reference is made to BB- IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioNTech are developing for the indication of a ctive immunization to
prevent coronavirus disease 2019 (COVID -19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS -CoV -2). The IND was effective on 29 April 2020 and the Emergency
Use Authorization (EUA) for Pfizer- BioNTech COV ID-19 Vaccine issue d on 10 May 2021.
Reference is also made to the protocol sfor the Post -Authorization Safety Studies(PASS)
submitted to the I ND19736(SN 0195) and EUA 27034 on 29 January 2021:
C4591008 entitled, “HERO Together: A post -Emergency Use Authorization
observational cohort study to evaluate the s afety of the Pfizer -BioNTe ch COVID -19
vaccine in US healthcare workers ”.
C45910 12entitl ed, “Post-Emergency Use Authorization Active S urveillance Study
among Individuals in the Veteran ’s Affairs He alth Syste m Rece iving Pfizer-BioNTech
Coronavirus Disease 2019 (COVID -19) Vaccine ”.
The present submission provides the:
Non-Interventional Study Interim Report version 1.0 for Study C459 1008
Non-Interventional Study Interim Report version 1.0 for Study C459 1012
This isbeing submitted to both BB -IND 19 736 and EUA 27034 in parallel.
FDA-CBER-2021-5683-1072504
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 30June 2021
Pfizer Confid ential
Page 2This submission has been scanned for vir uses us ing McAfee VirusS can Ente rprise Version
8.8 and is virus free . The submission is be ing sent via the Gateway .
Should you have anyquestions regarding t his submi ssion, or requi re additional informa tion,
pleasecontact me via phone a t 212-733-2613 ; via fac simile at 845 -474-3500; or via e -mail at
neda.aghaj [email protected] .
Sincerel y,
Neda Aghajani Memar, Pharm.D.
Directo r
Pfizer Global Regulatory Affairs
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph .D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-1072505