Document text
Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
06 July 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
REG ISTRATION 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.
SN0397
Re: Covid-19 Vaccine (BNT162/PF -073020 48)BB-IND 19736
Response to FDA 30 June 2021Information R equest
Dear Dr. Gruber ,
Reference is made to BB- IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioNTech are developing for the indication of active immunization to
prevent coronavirus disease 2019 (COVID -19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS -CoV -2). The IND was effective on 29 April 2020 .
Further reference is made to CBER’s 30June 2021 Information Requ estregarding updating
Informed Conse nt Documents and Investigator's Brochure with information related to
myocarditis and pericarditis.
The present submission provides R espon se to FD A30 June 2021 Information Request in
Module 1.11.3.
This submission has been scanned for viruses us ing McAfe e VirusS can Ente rprise Versio n
8.8 and is virus free . The subm ission is be ing sen t via the Gate way.
Shouldyou have an y questio ns re garding this submi ssion, or requi re additionalinformatio n,
pleasecontact me via phone a t 212-733-2613; via fac simile at 845-474-3500; or via e -mail at
neda.aghaj animemar@pfi zer.com .
Sincerel y,
FDA-CBER-2021-5683-1072509
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 06 July 2021
Pfizer Confid ential
Page 2Neda Aghajani Memar, Pharm .D.
Director
Pfizer Global Regulatory A ffairs
CC: Ramac handra S. Naik, Ph.D .
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-1072510