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From: Smith, Michael (CBER)
Sent: Monday, August 9, 2021 12:06 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 sequencing data
Elisa,
The review team has the below clinical questions for you regarding study C4591001. Please respond as soon as possible and no later than Thursday, August
12, 2021.
One subject in the vaccine group, (Site No: 1252, Subject No: 12521010): 80-
year -old white, non- Hispanic male who received two doses of BNT162b2 (17 Aug
2020 and 08 September 2020), died from COVID pneumonia.
If available, please provide sequencing data for the virus isolated fr om this
patient.
If there is available genomic sequencing data for any other COVID -19 case,
especially those with fatal outcomes, and those from HIV positive subjects, please
submit that 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 Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
FDA-CBER-2021-5683-1024771
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FDA-CBER-2021-5683-1024772