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From: Smith, Michael (CBER)
Sent: Tuesday, August 3, 2021 6:08 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/stats IR
Elisa,
The review team has two clinical/stats questions and they requested a response by Friday, August 6, 2021.
1. In your response submitted in STN 125742/0.17 dated July 26, 2021 (to CBER’s comment 4 sent on July 22, 2021), you clarified that Episodes B and
C were merged into one single COVID -19 case for Subject C4591001 1001
10031167 because this subject had the severe symptom of hospitalization from 22 November 2020 to 23 December 2020. While hospitalization is a
criterion for severe COVID -19 according to the CDC definition, it is not a
symptom or criterion defined in the study protocol for COVID -19 case
definition. In addition, the first positive PCR result was obtained on 19 December 2020, which was ~1 month after the hospitalization, making it
difficult to corroborate that the hospitalization was due to COVID -19.
Therefore, we disagree with the mergence of these two episodes based on
hospitalization. Please provide updated efficacy analyses accordingly, to
exclu de this subject, and participants 12 through 15 years of age for the
shell tables requested.
2. Please submit the SAS programs used to generate efficacy analyses according to the CDC -definition, i.e., adc19ef -ve-sev-7pd2 -cdc-wo-eval and
adc19ef -ve-sev-7pd2 -cdc-eval.
Regards,
Mike
FDA-CBER-2021-5683-1024727
- 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]
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FDA-CBER-2021-5683-1024728