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From: Smith, Michael (CBER)
Sent: Wednesday, February 23, 2022 3:06 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: IR RE Cumulative Analysis of Po st-Authorization Adverse Event Reports in
Individuals Aged Between 12 and 15 Year of Age
Kate,
We are reviewing the Cumulative Analysis of Post-Authorization Adverse Event Reports
in Individuals Aged Between 12 and 15 Year of Age (BLA 125742/45, Module 5.3.6,
dated December 1, 2021; received Dece mber 16, 2021) and have the following
information requests.
1. The cumulative analysis shows 18 adverse events reports with fatal outcomes
among individuals 12-15 years of age. Please provide preferred terms and
narratives for each of these fatal reports and indicate how many and which of the reports were U.S. vs foreign.
2. The cumulative analysis indicates that 1,215 serious reports were received for
individuals 12-15 years of age. Please prov ide the number of serious reports that
were U.S. vs. foreign.
Please provide a response to this information request by COB March 1, 2022.
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 Applications
Tel: 301-796-2640
[email protected] 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: 2022.02.23 15:08:38 -05'00'
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500342
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FDA-CBER-2022-5812-0500343