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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
29July 2021
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 SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
REGIST RATION 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 ( BNT1 62/PF-0 7302048)
Response to 13 Ju ly2021 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 B B-IND 1 9736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
The purpose of this submission is to respond to CBER ’s13July 2021 Infor mation Request to
Pfizer, received via email from Captain Michael Sm ith, PhD (CBER) .Therequests are
regarding CBER request to add m yocarditis and p ericarditis to the Pharmacovigilance Plan
(PVP) as an important i dentified risk. TheUpdated PVP,Clean copy andTrack Changes
copy which incorporate the addition of myocarditis and pericarditis as an impor tant i dentified
riskis pro vided in Modu le 1.16.1.
Should y ou have any questions re garding t his submission, or re quireadditional inform ation,
pleas e contact me vi aphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark instul [email protected] .
Sincerel y,
FDA-CBER-2021-5683-0950142
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 29July 2021
PfizerConfid ential
Page 2Elisa Harkins
Global R egulatory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Naik, Ph.D.
FDA-CBER-2021-5683-0950143