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Pfizer Documents (PHMPT/FDA)

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Pfizer 16 Plus Documents

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PFIZER CONFIDENTIAL  
Page 1 Global Regulatory Affairs - Vaccines  
Pfizer Inc.  
235 East 42nd Street  
New York , NY 10017  
Global Product Development  
16 June 2021 THIS DOCUMENT CONTAINS 
CONFIDENTIAL AND/OR TRADE SECRET 
INFORMATION THAT IS DISCLOSED 
ONLY IN CONNECTION WITH THE 
LICENSING AND/OR REGISTRATION OF 
PRODUCTS FOR PFIZER I NC 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. 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 , MD 20993 -0002  
IND No. 19,736  for COVID -19 Vaccine (BNT162, PF -07302048)  
eCTD Sequence 0369 Serial No. 0368  
IND Annual Report:  Reporting Period  22-APR -2020 – 21-APR -2021  
Dear  Director: 
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 Development Safety 
Updated Report (DSUR) format described in International Conference on 
Harmonization; Guidance for Industry E2F Development Safety Update Report 
(ICHE2 F), August 2011 . 
This submission has been scanned  for viruses using McAfee Vir usScan Enterprise 
Version 8.8 and is virus free.  The submission is being sent via the Gateway.  
Should you have any questions regarding this submission please contact me via phone at 
(212) 733 -2613 ; or via email at [email protected] .  
Sincerely,  
Neda  Aghajani Memar , PharmD  
Senior Manager  
Global Regulatory Affairs - Vaccines  
FDA-CBER-2021-5683-1102864