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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
20August 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 FDA 20 August 2021 Information Request
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA ) submitted 18May 2021 for
the COVID -19 mRNA Vaccine ( BNT162 /PF-0730204 8) developed by BioNTec h and Pfize r
under BB -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’s 20 August 2021 Information
Request, rec eived via email from Laura Gottschalk, Ph .D.(CBER). The r equest is regarding
completion of the table for Study C4591001 f requency of adverse e vents by age group and
overall b y study period in the blinded f ollow -up.TheResponse to FDA 20 August 2021
Information Request is provided in Module 1.11.3.
Should y ou ha ve any questions re garding this subm ission , or re quireadditional information,
please contact me viaphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark instul l@pfizer. com.
Sincerel y,
FDA-CBER-2021-5683-0950397
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 20August 2021
Pfizer Confid ential
Page 2Elisa Harkins
Global R egulatory Lead
Global Regulator y Aff airs –Vaccine s
CC: Ramac handr a S. Naik, Ph.D.
Captain Micha el Smith , Ph.D .
Laura Gottshalk, Ph.D.
FDA-CBER-2021-5683-0950398