Document text
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 125742/8
COMIRNATY (COVID-19 mRNA Vaccine)
WAIVER REQUEST –LOT DISTRIBUTION REQUI REMENTS
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 bySARS-CoV-2in individuals ≥16 years of age issued on 23 August
2021.
Per 21 CFR 600.81 a Lot Distribution Report (L DR) is to be provided in electronic format
every six months or at times other than every 6 months as determined at the time of approv al.
For COMIRNATY, the LDR was re quested monthly per the BLA approval issued on 23
August 2021. The purpose of this General Correspondence is to request an extension of the
first reporting per iod as well as a waiver to the monthly reporting requirement.
A Module 1, 1.12.5 Request for a waiver –Lot Distribution Reports is included and contains
ajustification for the waiver .
Pfizer respectfully request a re sponse to this waiver request within 14 days.
This submissi on has been scanned for vir uses usingMcAfee VirusScan Enterprise Version
8.8 and is virus fr ee. The submission is be ingsent via theGateway.
090177e198112ec8\Approved\Approved On: 14-Sep-2021 19:24 (GMT)
FDA-CBER-2021-5683-0951548
Marion Gruber, Ph.D. , Director Page 2of 2
BLA 125742 15September 2021
Pfizer Confid ential
Page 2Should you have any quest ions regarding this submission, or require additional information,
please contact me via phone a t 214-918-5262 or via e-mail at [email protected] .
Sincerely,
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.
090177e198112ec8\Approved\Approved On: 14-Sep-2021 19:24 (GMT)
FDA-CBER-2021-5683-0951549