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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
7 June 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)
COVID -19 Case Strain Sequencing Report
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. Further reference is made to the A gency ’s 9 March 2021
request for COVID -19 case strain sequencing data to be included in the BLA and the 16
April 2021 agreement that th ese data would be provided during the course of BLA review b y
7 June 2021.
The purpose of the present submission is to provide theCOVID -19 Case Strain Sequencing
Report . This report is located in Module 5.3.5.1.
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
FDA-CBER-2021-5683-0950039
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 7 June 2021
Pfizer Confid ential
Page 2Global Regul atory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Nai k, Ph.D.
FDA-CBER-2021-5683-0950040