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From: Smith, Michael (CBER)
Sent: Tuesday, July 27, 2021 10:44 AM
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: RE: [EXTERNAL] RE: STN 125742.0: IR RE assessment of vaccine effectiveness
Elisa,
Sorry, but the below question was inadvertently omitted from the earlier IR. Additionally, the review team has requested a response to this question by
Friday, Jul y 30, 2021.
Please calculate the cumulative incidence rates of vaccine and placebo arms at
Day 57 and Day 224 and estimate the Risk Difference and Risk Ratio with their
95% CI.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
From: Harkins Tull, Elisa < [email protected] >
Sent: Tuesday, July 27, 2021 10:11 AM
To: Smith, Michael (CBER) < [email protected] >; Aghajani Memar, Neda
<[email protected] >; D evlin, Carmel M <[email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >
Subject: [EXTERNAL] RE: STN 125742.0: IR RE assessment of vaccine effecti veness
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
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Hi Mike,
I confirm receipt.
Best regards,
FDA-CBER-2021-5683-1024716
Elisa
From: Smith, Michael (CBER) < [email protected] >
Sent: Tuesday, July 27, 2021 10:01 AM
To: Harkins Tull, Elisa < [email protected] >; Aghajani Memar, Neda
<[email protected] >; D evlin, Carmel M <Ca [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >
Subject: [EXTERNAL] STN 1 25742.0: IR RE assessment of vaccine effectiveness
Elisa,
The review team has the below Information Request for Pfizer and BioNTech
Manufacturing GmbH.
1. Regarding the cumulative incidence rates, please calculate vaccine effectiveness with confidence int ervals during the two intervals of interest
separately from days 35 -91 (i.e., 8 weeks of observation after dose 2) and
from days 91 -224 (more prolonged follow up post vaccination series).
2. We also request assessment of vaccine effectiveness during a time p eriod
that is entirely further out from vaccination (e.g., starting at 4 months post-dose 2). We acknowledge though that at some point unblinding and
placebo cross -over started, and there may have been differential loss
between the two groups from blinded follow -up that could introduce bias
and/or confound the analyses.
Please respond within one week from today.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
FDA-CBER-2021-5683-1024717
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-2021-5683-1024718