Document text
PFIZER CONFIDENTIAL
Page 1 Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Global Product Development
15 April 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 INC 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. Marion Gruber, Ph.D. Director Food and Drug Administration Office of Vaccines Research and Review Center for Biologics E valuation and Research
c/o Central Document Room 10903 New Hampshire Avenue, WO71-G112 Silver Spring, MD 20993-0002
Re: COVID-19 Vaccine ( BNT162/PF-07302048) BB-IND 19736
eCTD Sequence 0289 Serial No. 0288
IND Summary Monthly Safety Rep ort: Reporting Period 01-MAR-2021 –
31-MAR-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 th e Summary Monthly
Safety Report (SMSR) format described in International Conferen ce on Harmonization;
Guideline E2C (R2) Periodic bene fit-risk evaluation report (PBR ER), Step 5, January
2013.
In addition, as previously agreed with CBER, Pfizer/BioNTech are hereby submitting
our plan for reporting Individual Case Serious Reports (ICSRs) and their relation to the
SMSR. Following Emergency Use A uthorization of Pfizer-BioNTech COVID-19
Vaccine on 11 December 2020 (EUA 27034), Pfizer processed and reported ICSRs on
behalf of BioNTech to VAERS as s pontaneous cases per the Postma
rketing Adverse
Drug Experience (PADE) Compliance Program reporting schedule. That is, serious and
unlisted cases (foreign and
dome
stic) were processed and submitted within 15 calendar
days. Serious Listed domestic cases were submitted within 30 calendar days, not within
15calendar days as stipul ated in the 11 December 2020 Letter of Authorization
FDA-CBER-2021-5683-1084593
BB-IND 19736 15 April 2021
PFIZER CONFIDENTIAL
Page 2 (LOA). As stipulated in Section G of the February 25, 2020 Let ter of Authorization,
Pfizer/BioNTech have been submitting monthly periodic reports w hich summarize all
spontaneous reports received, i ncluding all death cases, hospit alizations, multisystem
inflammatory syndrome, serious and non-serious domestic/foreign
cases, and administration errors. In addition, all cases received and uploaded in the
safety database are included in w eekly signal detection activit ies, regardless of
seriousness or their statu s in the ICSR workflow . Effective 1 May 2020, we will also
submit Serious Listed domestic cases within 15 days in accordan ce with the LOA.
This submission has been scanned for viruses using McAfee VirusScan E
nterprise
Version 8.8 and is virus free. T he submission is being sent vi a the Gateway.
Should you have any questions regar ding this submission please contact me via phone at
at 212-733-2613; or via email at neda [email protected].
Sincerely,
Neda Aghajani Memar, Pharm.D.
Director Pfizer Global Re gulatory Affairs
FDA-CBER-2021-5683-1084594