Document text
From: Smith, Michael (CBER)
Sent: Monday, June 13, 2022 4:28 PM
To: Mineo, Gosia
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; MaguireThon, Me ghan <[email protected]>; Devlin,
Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]>
Subject: STN 125742/45: Delay in the review of this efficacy supplement
Dear Ms. Mineo:
Please reference the COVID- 19 Vaccine, mRNA (CORMIRNATY) Efficacy Supplement
STN 125742/45, that you submitted on December 16, 2021 fo r active immunization to
prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS CoV 2) in adolescents 12 through 15 years of age. In response to the Coronavirus Disease 2019 (COVID-19) public health emergency,
FDA’s Center for Biologics Evaluation and Research (CBER) has taken steps to
prioritize work that advances the nation’s response during this national
emergency. Therefore, we will not be able to meet the goal date of June 17, 2022, for
your submission referenced above. We will continue to review your submission as time and resources allow and will notify you of our final action upon completion of our review. For additional information regarding CBER oper ations during this public health
emergency, please see the CBER COVID-19 C BER Regulated Biologics page found at
https://www.fda.gov/vaccines-blood-biologics /industry-biologics/coronavirus-covid-19-
cber-regulated-biologics and guidance for industry, Effects of the COVID-19 Public
Health Emergency on Formal Meetings and Us er Fee Applications – Questions and
Answers at https://www.fda.gov/media/138358/download .
Please confirm receipt of this email and let us know if you have any questions.
Regards, Mike
Mike Smith, Ph.D. Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301-796-2640
[email protected] Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.06.14 08:01:54 -04'00'
(b) (6)
FDA-CBER-2022-5812-0500493
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FDA-CBER-2022-5812-0500494