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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
02 August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET 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)
Preliminary requested changes and comments on the draft Package Insert for
COMIRNATY
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 19 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed by BioNTech and Pfize r
under BB -IND19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The present submission provides responses and updates to the Agency ’s28 July 2021
Preliminary requested changes on the draft package insert for COMIRNATY. The updated
draft package insert is provided in Module 1.14.1 :
Track change ( Word)
Annotated ( PDF)
Clean cop y (PDFand Word)
Should you have any questions re garding this submission, or re quireadditionalinformation,
pleasecontact me vi aphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark [email protected] .
FDA-CBER-2021-5683-0950169
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 2 August 2021
Pfizer Confid ential
Page 2Sincerely,
ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs –Vaccines
CC: Ramac handra S. Naik, Ph.D.
FDA-CBER-2021-5683-0950170