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PFIZER CONFIDENTIAL
Page 1Global Regulatory Affairs - Vaccines 
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Global Product Developm ent
15 September 2021THIS DOCUMENT CONTAINS 
CONFIDENTIAL AND/OR TRADE SECRET 
INFORMATION THAT IS DISCLOSED 
ONL Y IN CONNECTION WITH THE 
LICENSING AND/OR REGI STRATION OF 
PRODUCTS FOR PFIZER INC OR ITS 
AFFILIATED COMPANIES.  THIS 
DOCUMENT SHOULD NOT BE DISCLOSED 
OR USED, I N WHOLE OR IN PART, FOR 
ANY OTHER PURPOSE WITHOUT THE 
PRIOR WRITTEN CONSENT OF PFIZER 
INC.Marion Gruber, Ph.D.
Director
Food and Drug Administration
Office of Vaccines Research and Review  
Center for Biologics Evaluation and Research 
c/o Central Document Room
10903 New Hampshire Avenue, WO71-G 112 
Silver Spring, M D 20993-0002
Re: COVID -19 Vaccine (BNT162/PF -07302048) BB -IND 19736
eCTD Sequence 0491             Serial No. 0491
IND Summary Monthly Safety Report:  Reporting Period 01-AUG-2021 – 31-AUG-
2021
Dear Dr. Gruber,
The provided report summarizes information associated with the subject IND during the 
reporting period.  Please note that the format of the IND Annual Report for 2021 has 
been converted from the format described in 21 CFR 312.33 to the Summary 
Monthly
 
Safety Report (SMSR) format described in International Conference on Harm onization; 
Guideline E2C (R2) Periodic benefit -risk evaluation report (PBRER), Step 5,  January 
2013 .
This submission has been scanned for viruses using McAfee Vir usScan Enterprise 
Versi on 8.8 and is virus free.  The submission is being sent via the Gateway.
FDA-CBER-2021-5683-1122590
BB-IND 19736           15 September 2021
PFIZER CONFIDENTIAL
Page 2Should you have any  questions regarding this submission please contact me via phone 
at 214-918-5262; or via ema il at [email protected].
Sincerel y,
Amit Patel 
Director
Global Regulatory Affairs – Vaccines
FDA-CBER-2021-5683-1122591