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Pfizer Inc
500 Arcola Road
Collegeville, PA 19436
Global Product Developm ent
10July 2020
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologi cs 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 I TS 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.
SN0030
Re: COVID -19Vaccine (BNT162; PF-07302048) BB-I ND19736
IND Amendment –Clinical :Response to FDA Information Request
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 prevention of COVID- 19 in adults
≥18years of age. The IND was effective on April 29, 2020 and Pfizer initiated a Phase 1/2
USclinical study (C4591001) on May 4, 2020.
The purpose of this submission is to provide clinical assay s (IgG binding and SARS -CoV -2
neutralizing antibod y assays) as requested b y CBER on 06 July 2020 in support of the
C4591001 Phase 2b/3 study start scheduled for the week of 20 July 2020 ( Module 1.11.3
Respon se to FDA Request for Information ).
This submission has been scanned for viruses using McAfee VirusSc an Enter prise Version
8.8 and is virus free. Thesubmission is being sent via the Gateway .
Should y ou have any que stions regarding thissubmission, or re quire additional inform ation,
please c ontact me via phone at 215-280-5503; via facsimile at 845 -474-3500; or via e -mail at
[email protected] .
Sincerel y,
FDA-CBER-2021-5683-1072444
Marion Gruber, Ph.D., Direct or Page 2of 2
BB-IND 19736 10July 2020
Pfizer Confidential
Page 2Elisa Harkins
Global R egulatory Lead
Global Regulatory Affairs – Vaccines
CC: Rama chandra S. Naik, Ph.D.
FDA-CBER-2021-5683-1072445