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PFIZER CONFIDENTIAL
Page 1Global Regulatory Affairs -Vaccines
Pfizer Inc.
500 Arcola Road
Collegeville , PA19426 -3982
Global Product Developm ent
15 January  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- G112
Silver Spring , MD20993 -0002
Re: COVID -19 Vaccine (BNT162/PF -07302048) BB -IND 19736
SN 0184
IND Summary Monthly Safety Report:  Reporting Period 01-DEC -2020 – 31-DEC -
2020
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 2020 has 
been converted from the format described in 21 CFR 312.33 to the Summary  Monthl y
Safety Report ( SMS R) format described in International Conference on Har monization; 
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-2021-5683-1078874
15 January 2021
PFIZER CONFIDENTIAL
Page 2Should y ou have any  questions regarding this submission please contact mevia phone at 
215-280-5503 ;or via email at [email protected] .
Sincerel y,
Elisa Harkins
Global Regulatory  Lead
Global Regulatory Affairs - Vaccines
FDA-CBER-2021-5683-1078875