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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
16July2021
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)
Response to 6 July 2021 Information Request
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 Pfizer
under BB -IND19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of th e current document is to re spond to CBER ’s6 July2021 Information
Request to provide a description of the nature of the severe AEs and the AEs w hich lead to
withdrawal from the stable HIV cohort at an y time during the study that was provided by
Captain MichaelSmith, PhD (CBER) to Pfizer via email. TheResponse to CBER ’s 6 July
2021 Information Request regarding datasets is provided in Module 1.11.3.
Should you have any questions re garding this submission, or re quire additionalinformation,
pleasecontact me vi aphone at 215-280-5503; via facsimile at 845-474-3500; or via e -mail at
elisa.hark [email protected] .
Sincerely,
Elisa Harkins
FDA-CBER-2021-5683-0950083
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 16July 2021
Pfizer Confid ential
Page 2Global Regul atory Lead
Global Regulatory Affairs –Vaccines
CC: Ramac handra S. Naik, Ph.D.
FDA-CBER-2021-5683-0950084