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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
19August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl 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 ( BNT162/PF-07302048)
Response to CBER 18 August2021 Information Request Regarding
Identification of BLA CompliantLots and Dear HCP Letter
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 2021 for
the COVID-19 mRNA Vaccine (BNT162/P F-07302048) developed by BioNTec h and Pfizer
under BB -IND19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of thissubmission is to respond to CBER ’s18August2021 request received via
email fromRamachandra Naik, Ph.D. (CBER)to submit to the BL A the graphic for
identification of BLA -compliant lots and Dear HCP letter previously communicated b y email
from Donna Boyce, Senior Vice -President, Head of Global Regulatory Affairs, Pfizer Inc. to
Mary Malarky, Director, OCBQ/FDA on 16 August 2021. The Response to FDA 18 August
2021 Information R equestis provided in Module 1.11.4.
Should you have any questions re garding this subm ission, or requireadditionalinformation,
pleasecontact meviaphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark instull@pfizer. com.
FDA-CBER-2021-5683-0951265
Marion Gru ber, Ph.D., Director Page2of 2
BLA125742 19August2021
Pfizer Confid ential
Page 2Sincerely,
ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs –Vaccines
CC: Ramachandra S. Naik, Ph.D.
Captain Micha el Smith, Ph.D.
Laura Gottshalk, Ph.D.
FDA-CBER-2021-5683-0951266