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From: Smith, Michael (CBER)
Sent: Wednesday, May 4, 2022 10:25 AM
To:Collins, Kathleen Mary Catherin e
Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; MaguireThon, Meghan <[email protected]>; Mineo,
Gosia ; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>Subject: STN 125742/45: IR RE placebo recipient information contained in the PI
Kate,
The review team has the below information request regarding placebo recipient
information contained in the Package Insert (PI) that was submitted to STN 125742.45 and they requested a response by Monday, May 9
th.
Please confirm the number of placebo recipients who reported nausea from Dose 1 through 1 month after Dose 2, based on the September 2, 2021 data cutoff. There appears to be 2 placebo recipients who reported nausea from Dose 1 through 1 month post Dose 2, based on our analysis of the 6-mo ADAE dataset.
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 AdministrationCenter for Biologics Evaluation & ResearchOffice of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: [email protected]
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Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.05.04 10:26:39 -04'00'
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