Document text
Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
07September 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 125742/5
COVID-19mRNAVaccine(BNT162/PF-07302048)
Request for Comments and Advice – Pfizer/BioNTech’ s Plan for Reporting
Adverse Events
Dear Dr. Gruber ,
Reference is made to the Biologics License Application (BLA) 125742 for COMIRNATY
(COVID-19 mRNA Vaccine ), developed by BioNTech and Pfizer for theprevention of
COVID-19 caused by SARS-CoV-2in individuals ≥16 years of age issued on 23 August
2021.
The present submission provides a Request for Comments and Advice (Module 1.12.4)
regarding Pfizer /BioNTech ’s request for reporting adver seevents.
Pfizer/BioNTech respectfully request feedback from the Agency regarding the acceptability
of our proposed by 10 September 2021.
This submission has been scanned for vir uses using McAfee VirusS can Enterprise Version
8.8 and is virus fr ee. The submission is be ingsent via 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 Amit [email protected] .
Sincerely,
FDA-CBER-2021-5683-0951454
Marion Gruber, Ph.D. , Director Page 2of 2
BLA 125742 /5 07September 2021
Pfizer Confid ential
Page 2Amit 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.
FDA-CBER-2021-5683-0951455