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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs -Vaccines Pfizer Inc. 500 Arcola Road Collegeville , PA19426 -3982 Global Product Developm ent 15 February 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 eCTD Sequence 0214 Serial No. 0213 IND Summary Monthly Safety Report: Reporting Period 01-JAN-2 021 – 31-JAN- 2021 Dear Dr. Gruber, The provided report summarizes information associated with the subject IND during the reporting period. Please note that the fo rmat 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-2021-5683-1079257 IND 19736 15 February 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-2021-5683-1079258