Document text
Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
09July 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 S ECRET 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 PRI OR
WRITTEN CONSENT OF PFIZER INC.
Re: BLA 125742
COVID -19 mRNA Vaccine ( BNT162/PF -07302048 )
Response to FDA ’s25 June 2021 Information Request Regarding a Request for
the Lot Release Protocol (LRP) Template and for Samples and R eagents
Dear Dr. Gruber,
Reference is made to the Biologics License Application (BLA) submitted 18 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed b y BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused b y SARS -CoV -2in
indiv iduals ≥16 y ears of age.
On 2 5 June 2021, the Agency sentan Information Request regarding for the lot release
protocol (L RP) template and for samples and reagents. The requested information is provided
inResponse to 25 June 2021 FDA IR in Module 1.11.1.
The requested samples and reagents were shipped to the following address in four shipments
as detailed below :
Emnet Yitbarek
Food and Drug Administration
Center for Biologics Evaluation and Research
Division of Biological Standards and Quality Control
10903 New Hampshire Avenue
FDA-CBER-2021-5683-1149305
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 09July 2021
Pfizer Confidential
Page 2WO75, G -650
Silver Spring, MD 20993
-Three drug substance batches, shipped on July 8, 2021
-Three drug product lots, shipped on July 8, 2021
-Drug substance, drug product and lipid reference materials/controls and ,
shipped on July 8, 2021
- Materials for In vitro expression, RT -PCR and ddPCR, shipped on July 7, 2021
Should y ou have any questions regarding this submission, or require additional information,
please contact me via phone at 215 -280-5503; via f acsimile at 845 -474-3500; or via e -mail at
[email protected] .
Sincerel y,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
(b) (4)
FDA-CBER-2021-5683-1149306