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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
19May2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologicsEvaluation and Research
DocumentControl Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
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THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
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INC OR ITS AFFILIATED COMPANIES. THIS
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Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
REQUEST FOR PROPRIETARY NAME REVIEW
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed by BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of the present submission is to provide theRequest for Proprietary Name
Reviewin Module 1.18. As detailed in the 2016 FDA Guidance for Industry - Contents of a
Complete Submission for the Evaluation of Proprietary Names , this Request for Proprietary
Name Review is being submitted as a separate submission to theBLA. This request was
previously reviewed under BB -IND 19736 and theAcceptable At This Time Lette r was
received from FDA on 20 November 2020. Please note, this is the same proprietary name
that has been accepted and is currentl y in use globally for all reg ions who have Conditional
Marketing Authorization forthis vaccine ,including the European Union.
Should you have any questions re garding this submission, or requi re additionalinformation,
pleasecontact me vi aphone at 215-280-5503; via facsimile at 845-474-3500; or via e -mail at
elisa.hark [email protected] .
FDA-CBER-2021-5683-0780558
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 19May2021
Pfizer Confid ential
Page 2Sincerely,
Elisa Harkins
Global Regul atory Lead
Global Regulatory Affairs –Vaccines
CC: Ramac handra S. Naik, Ph.D.
FDA-CBER-2021-5683-0780559