Document text
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
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 18 May 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.
Reference is made to Amendment 132 (dated 09 April 2021) to EUA 27034 to extend
emergency use authorization of the Pfizer -BioNTech COVID- 19 vaccine to individuals
12-15 years of age . Further reference is made to the teleconference held on 08 April 2021
and Roll 1 of BLA STN 125742/0 (dated 06 May 2021).The purpose of th e current
document is to re spond to CBER ’s18 May 2021 Infor mation Request regarding datasets tha t
was provided by Captain MichaelSmith, PhD (CBER) to Pfizer via email.
The purpose of the present submission provides theResponse to CBER ’s 18May2021
Information Request in Module 1.1 1.3.
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] .
FDA-CBER-2021-5683-0780565
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-2021-5683-0780566