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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
2 July 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 AND/OR
REGISTRA TION 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
COVID -19 mRNA Vaccine ( BNT1 62/PF-0 7302048)
Response to 29 June 2021 Information Request
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA ) submitted 19 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed by BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
The purpose of th e current document is to re spond to CBER ’s29 June 2021 I nformation
Request regarding datasets tha t was pr ovided by Captain Michael Smith, PhD (CBER) to
Pfizer via email. TheResponse to CBER ’s 29June 2021 I nformation Request regarding
datasets i s provided in Module 1.11.3.
Should y ou have any questions re garding t his submission, or re quire additional inform ation,
pleas e contact me vi aphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e -mail at
elisa.hark instul [email protected] .
Sincerel y,
Elisa H arkins
Global Regul atory Lead
FDA-CBER-2021-5683-0950053
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 2 July 2021
Pfizer Confid ential
Page 2Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Nai k, Ph.D.
FDA-CBER-2021-5683-0950054