Document text
From: Smith, Michael (CBER)
Sent: Monday, March 7, 2022 4:09 PM
To: Collins, Kathleen Mary Catherine
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Mineo, Gosia Harkins Tull, Elisa
<[email protected]>; Devlin, Carmel M <[email protected]>
Subject: STN 125742/45 – Comirnaty sBLA – Clinical-statistical comments regarding updated
immunobridging analyses and solicited adverse reaction frequencies
Dear Ms. Collins,
Our review of the information provided in your sBLA STN 125742/45 for COMIRNATY
(COVID-19 mRNA Vaccine) for active immunization to prevent COVID-19 caused by SARS-CoV-2, to include individuals 12 through 15 years of age, is ongoing. We have the following comments and requests for additional information.
1.The submitted immunobridging data (adolescents 12 through 15 years of age vs.
young adults 16 through 25 years of age in Study C4591001) with an estimated geometric mean titer ratio of 1.76 and a seroresponse rate difference of -2.1% appear to be based on an LLOQ of 20. Please confirm whether the assay LLOQ has been revised to 41. Please provide updated immunobridging analysis results (i.e., geometric mean titer ratio and seroresponse rate difference) as appropriate.
2.Please clarify whether additional solicited adverse reaction data for adolescents 12
through 15 years of age in Study C4591001 have been collected up to the
September 2, 2021 data cutoff since EUA issuance. Please submit updated solicited adverse reaction frequencies as appropriate, annotating any changes to the results.
Please provide your response in an Am endment to STN 125742/45, as soon as
possible. If you have any questions about this communication, please feel free to contact us.
Regards,
Mike- Please confirm receipt of this email and let us know if you have any questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & ReviewDivision of Vaccines and Related Products ApplicationsMichael J.
Smith -S4Digitally signed by Michael J. Smith -S4 DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0014080934, cn=Michael J. Smith -S4 Date: 2022.03.07 16:10:08 -05'00'
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500349
Tel: 301-796-2640
[email protected]
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS
ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND
PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a
person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action
based on the content of this communication is not authorized. If you have
received this document in error, please immediately notify the sender immediately by e-mail or phone.
FDA-CBER-2022-5812-0500350