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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
05August 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
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
COVID -19 mRNA Vaccine ( BNT1 62/PF-0 7302048)
Response to 22 Ju ly2021 and 03 August Information Request s
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 B B-IND 1 9736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
The purpose of this submission is to respond to CBER ’s22 July 2021 Infor mation Request to
Pfizer, received via email from Laura Gottschalk, PhD (CBER) . The present follow up
submission provides t he efficacy 508tables , while the safety 508 tables will be provided on
13 August 2021. Additional reference is made to CBER’s 03 August 2021 Information
Request received via email from Michael Smith, PhD (CBER) regarding Subject C4591001
1001 10031167 and SAS programs used to generate efficacy anal yses.
TheResponse to CB ER’s22 July 2021 and 03 August 2021 Information Requests is
provided in Modu le 1.11.3.
Should y ou have any questions re garding t his su bmission, or re quireadditional inform ation,
pleas e contact me vi aphone at 215-280-5503; vi a facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark [email protected] .
FDA-CBER-2021-5683-0950190
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 05August 2021
Pfizer Conf idential
Page 2Sincerel y,
ElisaHarkins
Global R egulatory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Naik, Ph.D.
FDA-CBER-2021-5683-0950191