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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
20July2021
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 ’s16 July2021Information Request Regarding a Templated
Lot Release Protocol (LRP) Template and for Additional Sample Handling
Information
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 by SARS-CoV-2in
individuals ≥16 years of age.
On 25 June 2021, the Agency sentan Information Request regarding for the lot release
protocol (L RP) template and for samples and reagents. The requested information was
provided on09 July 2021. An additional request was made on 16 July 2021 to include a
templated lot release protocol as well as instructions for thawing and number of acceptable
freeze-thaw cycles. This information is provided in Response to 16 July2021FDA IRin
Module 1.11.1.
Should you have any questions regarding this submission, or require additional information,
please contact me via phone at 215 -280-5503; via facsimile at 845-474- 3500; or via e -mail at
[email protected] .
FDA-CBER-2021-5683-1149337
Marion Gruber, Ph.D., Director Page 2of 2
BLA125742 20July2021
Pfizer Confidential
Page 2Sincerely,
ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1149338