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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
15September 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biologics 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 AN D/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 125742/9
COMIRNATY (COVID-19 mRNA Vaccine)
Request for Comments and Advice – Biologic Product Deviation Reports
(BPDRs)
Dear Dr. Gruber ,
Referenceismade to the Biologics License Application (BLA) 125742 for COMIRNATY
(COVID-19 mRNA Vaccine ), developed by BioNTech and Pfizer for theprevention of
COVID-19 caused bySARS-CoV-2in individuals ≥16 years of age issued on 23 August
2021.
The purposeof this request for comments and advice is to obtain agreement with the Agency
for reporting of Biologic Product Deviation Reportto theEmergency Use Authorization as
well astothe BLA.
A Module1, 1.12.4Request for Comments and Advice –BPDRs is included.
This submission has beenscanned for vir uses usingMcAfee VirusScan Enterprise Version
8.8 and is virus fr ee. The submission is be ingsentvia theGateway.
Should you have any quest ions regarding this submission, or require additional information,
please contact me via phone at 214-918-5262 or via e-mail at [email protected] .
090177e19813a360\Approved\Approved On: 15-Sep-2021 15:36 (GMT)
FDA-CBER-2021-5683-0951551
Marion Gruber, Ph.D. , Director Page 2of 2
BLA 125742 15September2021
Pfizer Confid ential
Page 2Sincerely,
Amit Patel
Director
Global Reg ulatory Affairs-Vaccines
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph .D.
CC: Captain Michael Smith, Ph.D.
090177e19813a360\Approved\Approved On: 15-Sep-2021 15:36 (GMT)
FDA-CBER-2021-5683-0951552