Document text
From:Gottschalk, Laura
Sent:Wednesday, September 22, 2021 9:12 AM
To:Patel, Amit <[email protected]>
Cc:Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>;
Naik, Ramachandra <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Stafford, Adrienne Kaye <[email protected]>; Pelt, Rich R
< >
Subject:RE: [EXTERNAL] RE: STN 125742/5 -COVID-19 Vaccine, mRNA (COMIRNATY): Product
Correspondence -CBER Responses to Pfizer/BioNTech’s Plan for Reporting Adverse Events
Dear Mr. Patel,
We reference the follow-up questions submitted via email by Ms. Elisa Harkins on September 21, 2021
regarding CBER’s responses provided on September 10, 2021 to your request for comments and advice
regarding reporting adverse events submitted and received on September 7, 2021 (STN 125742/5). We
have the following responses to your follow-up questions:
Pfizer-BioNTech Question 1:
In CBER’s response related to Comment 1, second paragraph, related to “all other reports”, there is
reference to an additional requirement for all US ICSRs to be submittedas 15-day report independently
from seriousness and expectedness. There is reference to multisystem inflammatory syndrome in
children. The sub-bullet refers to submit all ICSRs to the BLA number. We are asking clarification and
confirmation from the Agency for the below scenario:a. With regards to reporting all serious cases of multisystem inflammatory syndrome in children
within 15d,if the patient’s age is reported as less than 16 years old, we should submit to the
EUA, rather than the BLA. Please confirm.
CBER Response to Question 1:
Please submit ICSRs to VAERS in accordance with 21 CFR 600.80. For serious cases of
multisystem inflammatory syndrome in children, if the patient’s age is reported as less than 16
years of age, please reference the EUA number (27034) in field G.k.3.3 “Name of
Holder/Applicant” in the following format “[name of applicant] EUA NNNNN.” Please omit the
authorization number field G.k.3.1.
Pfizer-BioNTech Question 2:
In the response to Comment 3, CBER requestedperiodic safety reports to BLA 125742, at monthly
intervals, in accordance with 21 CFR 600.80(c)(2), and including consolidated aggregate analysis for all
post-marketing and post-authorization spontaneous AE reports:
a. Pfizer on behalf of BioNTech understand the FDA’s request to mean that the SMSR in its current
format fulfills PAER requirements and no separate quarterly PAER is to be submitted. Based on
this we will continue to provide the SMSR as described in the EUA Letter of Authorization and
including all post-marketingand post-authorization spontaneous cases regardless of application.
Please confirm.
CBER Response to Question 2a:
The monthly report, submitted previously under the EUA as SMSR, can continue to be submitted
in the same format described in the EUA, and will fulfill the requirement for the descriptive
(b) (6)
FDA-CBER-2021-5683-1072425
information portion of PAER, as described in 21 CFR 600.80(c)(2)(ii)(A). A separate quarterly
PAER will not be needed. However, Individual Case Safety Reports (ICSRs) for serious, expected
and, nonserious adverse experiences (i.e.., non-expedited ICSRs), as required under the Periodic
Reporting requirement (21CFR600.80(c)(2)(ii)(B)), are still required and should be submitted
separately from the SMSR (i.e., submit non-expedited ICSRs to VAERS).
b. The SMSRwill be submitted to BLA 125742 with a cross-reference letter to IND 19736
documentingthat it was submitted to the BLA125742. Please confirm.
CBER Response to Question 2b:
Yes, this is correct.
c. Additionally, Pfizer acknowledges the subsections of SMSR aside from Appendix 2.1 are not
needed by FDA; however, we respectfully request to continue to submit the SMSR with all
appendices, including 2.1, since it is a global document and the additional Appendices are
included at the request of other Health Authorities. Does CBER agree?
CBER Response to Question 2c:
Yes, CBER agrees.
Please confirm receipt of this communication and let me know if you have any additional questions. If
no additional communications are anticipated regarding this Product Correspondence (STN 125742/5),
please let me know.
Best regards,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301-796-0798
[email protected]
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FDA-CBER-2021-5683-1072426