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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
28July 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologic s 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
REGISTR ATION 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)
Follow -up Response to 22 Ju ly2021 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 1 9736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
Further reference is made to CBER ’s22 July 2021 Information Request to Pfizer, received
via email from Laura Gottschalk , PhD (CBER) regarding clinical shell tables for Study
C4591001 and Pfizer/BioNTech’ s initial response submitted 26 July 2021 .
Thepresent submission provides Follow -up Response 1 for the R esponse to CBER 22 July
2021 Information Request Regarding C linical ShellTables for Study C45910 01inModu le
1.11.3 .
Should y ou have any questions re garding t his submission, or re quireadditional inform ation,
pleas e contact me vi aphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark instul [email protected] .
Sincerel y,
FDA-CBER-2021-5683-0950133
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 26July 2021
Pfizer Confid ential
Page 2Elisa Harkins
Global R egulatory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Naik, Ph.D.
FDA-CBER-2021-5683-0950134