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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
15 July2021
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 PRIOR WRITTEN CONSENT
OF PFIZER INC.
Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF -07302048 )
Response to FDA 13July2021 Information Request Regarding Preservative
Exception or Alternative Submittal
Dear Dr. Gruber,
Reference is made to the Biologics License Application (BLA) submitted 1 8May 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
13July2021, the Agency requested via email that BioNTech and Pfizer submit a request
and a justification for an exception or alternative to the requirement under 21 CFR 610.15(a)
that products in multiple -dose vials include a preservative because the candi date vaccine is
supplied in a multiple -dose vial that does not contain a preservative . Response to the
Agency’s Information Request is provided in Module 1.11.1 ( Response to 13 July2021 FDA
IR).The Request for Exception to the 21 CFR 610.15(a) Requireme nt for a Preservative is
provided in Module 1.12.5.
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-2021-5683-0950081
Marion Gruber, Ph.D., Director Page 2of 2
BLA125742 15 July2021
Pfizer Confidential
Page 2Sincerely,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Captain Michael Smith , Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-0950082