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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 October 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: B LA 125742/30
COMIRNATY (COVID-19 mRNA Vaccine)
Summary Monthly Safety Report
Dear Dr. Gruber,
Pursuant to 21 CFR 600.80 (c)(2), enclosed is the Summary Monthly Safety Report in
lieu of a quarterly Periodic Adverse Event Report, for the subject COMIRNATY
(Covid-19 mRNA Vaccine) listed above. The time period covered by this report is from
September 01, 2021 to September 30, 2021.
Please note that all periodic Individual Case Safety Reports (ICSRs) relevant to this
application number were filed separately in electronic E2B format through FDA's
Electronic Submission Gateway.
Pfizer considers the information submitted for BLA 125742/30 to be complete. Pfizer
is committed to respond to the reviewers’ questions promptly and to work with the
Division as needed to facilitate this review.
FDA-CBER-2021-5683-0952236
BLA 125742/30 15 October 2021
PFIZER CONFIDENTIAL
Page 2This submission has been scanned for viruses using McAfee VirusScan 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 214-918-5262
; or via email at [email protected].
Sincerel y,
Amit Patel
Director
Global Regulatory Affairs – Vaccines
FDA-CBER-2021-5683-0952237