Document text
From: Naik, Ramachandra
Sent: Wednesday, July 28, 2021 4:37 PM
To: Harkins Tull, Elisa < [email protected] >
Cc: Gottschalk, Laura < [email protected] >; Smith, Michael (CBER)
<[email protected] >; Aghajani Memar, Neda < [email protected] >; Devlin,
Carmel M <[email protected] >
Subject: STN 125742/0 - COMIRNATY (COVID -19 Vaccine, mRNA) – CBER comments regarding
postmarketing safety study(ies)
Dear Ms. Har kins,
Our review of your pharmacovigilance plan for COMIRNATY (COVID -19 Vaccine, mRNA) under BLA
125742 is ongoing. We have the following comments regarding postmarketing safety study(ies):
1. Please propose postmarketing observational safety study(ies) t o assess myo/pericarditis following
administration of COMIRNATY to:
a. Quantify the magnitude of risk by age, sex, and dose
b. Include follow up cases (e.g., via a registry) for recovery status and long -term sequelae
2. Please also provide your plans to characte rize subclinical cases of myocarditis.
Pl
ease include the following information for the postmarketing study(ies) proposal: study designs,
sample sizes and justification of sample sizes including number of subjects ≤30 years of age, information to be colle cted at baseline, frequency and methods for follow
-up da
ta collection, plan for duration of
long term follow -up a
nd information to be collected in follow -up,
study timeline and milestone dates
(final protocol submission date, study completion date, and final study report submission date; please provide dates in mm/dd/yyyy format).
Pl
ease provide your responses in an amendment to STN 125742/0 by Tuesday, August 3, 2021. We
recommend that you restate each item and follow it with your explanation or clarifica tion. Use of this
format helps organize the relevant information and provides a self -contained document that facilitates
future reference.
Please confirm receipt of this email and let me know if you have any questions or need additional
information.
Rega rds,
Ram
Ramachandra S. Naik, Ph.D.
Biologist (Regulatory) / Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301- 796-2640
ramachandra.naik @fda.hhs.gov
FDA-CBER-2021-5683-1024719
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FDA-CBER-2021-5683-1024720