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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
28July 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 ’s02July 2021 Information Request Regarding CMC
Information and Categorical Exclusion for an Environmental Analysis .
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
individuals ≥16years of age.
On 02July 2021, the Agency sentan Information Request regarding CMC information and
categorical exclusion for an environmental anal ysis.The requested information is provided in
Response to 02 July2021 FDA IR in 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-2021-5683-1149355
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 28July 2021
Pfizer Confidential
Page 2Sincerel 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.
FDA-CBER-2021-5683-1149356