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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 June 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 , MD
20993-0002
Re: COVID -19 Vaccine (BNT162/PF -07302048) BB -IND 19736
eCTD Sequence 0366 Serial No. 0365
IND Summary Monthly Safet y Report: Reporting Period 30-APR-2021 – 31-MAY-
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-2021-5683-1095409
BB-IND 19736 15 June 2021
PFIZER CONFIDENTIAL
Page 2Should you have any questions regarding this submission please contact me via phone
at
212-733-2613; or via email at [email protected].
Sincerel y,
Neda Aghajani Memar, Pharm.D.
Director
Pfizer Global Regulatory Affairs
FDA-CBER-2021-5683-1095410