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From: Smith, Michael (CBER)
Sent: Tuesday, July 6, 2021 6:40 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: Clinical IR RE the document titled “c4591001- interim -mth6 -report -body.pdf”
Elisa,
We have the following comment regarding the document titled “c4591001-
interim -mth6 -report -body.pdf”:
1. Please provide a description of the nature of the severe AEs and the AEs
which lead to withdrawal from the stable HIV cohort at any time during the
study. (e.g., in section 12.2.3.1.1.1. Participants with Confirmed Stable HIV
Disease – Blinded Placebo -Controlled Follow -Up Period From Dose 1 to 1
Month A fter Dose 2 and 12.2.3.2.1.1. Participants with Confirmed Stable
HIV Disease – Blinded Placebo -Controlled Follow -Up Period From Dose 1 to
the Unblinding Date. There were 2 SAEs in the BNT162b2 group (1 severe
and 1 life -threatening) and 2 SAEs in the placebo group (1 life -
threatening). There were 2 AEs leading to withdrawal in the BNT162b2
group (1 life -threatening) and 1 AE (life -threatening) leading to withdrawal
in the placebo group). Or if this information is available in the submission, please provide a reference to the location of the requested information.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administratio n
FDA-CBER-2021-5683-1024688
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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hone.
FDA-CBER-2021-5683-1024689