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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
30 August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl 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
REGISTRATION 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.
Re:BLA 125742/0
COVID-19mRNAVaccine(BNT162/PF-07302048)
Protocol Amendment for Study C45910 12and New Study C4591009 Protocol
Dear Dr. Gruber ,
Reference is made to the Biologics License Application (BLA) 125742/0 for COMIRNATY
(COVID-19 mRNA Vaccine )developed by BioNTech and Pfizer for theprevention of
COVID-19 caused by SARS-CoV-2in individuals ≥16 years of age issuedon 23 August
2021.
Reference is also made to BB- IND 19736 for the COVID -19 Vaccine (BNT162; PF -
07302048), which Pfizer and BioNTech are dev eloping for the indication of active
immunization to prev ent coronavirus disease 2 019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS- CoV-2).The IND was effective on 29 April
2020.
The present submission is to notify CBER that the following Post-Authorization Saf ety Study
(PASS) protocols were submitted to the BB- IND 19736:
4) StudyC4591009 entitled, “A Non-Interventional Post -Approval Safety Study of
Pfizer-BioNTech COVID -19 Vaccine in the United States” initially submitted to the
BB-IND 19736 on 30 August 2021 (S N 0469).
12)Study C4591012 entitled,“Post-Emergency Use Authorization Active Safety
Surveillance Study among Individuals in the Veteran ’s Affairs Health System
ReceivingPfizer-BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine ”initially
submitted t o the BB-IND 19736 (SN 0195)on 29January2021and the current
FDA-CBER-2021-5683-0951283
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 30 August 2021
Pfizer Confid ential
Page 2Clinical Protocol incorporating the changes of C4591012 Protocol Amendment 1
submitted to the BB-IND 19736 on 30 August 2021 (SN 0469).
This submission has been scanned for vir uses using McAf eeVirusScan Enterprise Version
8.8 and is virus free . The submission i s being sent via the Gateway.
Should you have any quest ions regarding this submission, or r equire additional information,
please contact me via phone at 214-918-5262 or via e-mail at [email protected] .
Sincerely,
Amit Patel
Director
Global Regulatory Affairs-Vaccines
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Got tschalk,Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-0951284