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From: Smith, Michael (CBER) < [email protected] >
Sent: Friday, July 2, 2021 11:38 AM
To: Harkins Tull, Elisa < [email protected] >; Aghajani Memar, Neda
<[email protected] >; Devlin, Carmel M <Ca [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >
Subject: RE: [EXTERNAL] R E: STN 125742.0: Clinical IR RE document titled “bnt162- 01-interim3 -report -
body”
Elisa,
I discussed this with the clinical team and Pfizer’s assumption as outlined is
correct.
Regards,
Mike
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review O fficer
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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From: Harkins Tull, Elisa < [email protected] >
Sent: Friday, July 2, 2021 9:01 AM
To: Smith, Michael (CBER) < [email protected] >; Aghajani Memar, Neda
FDA-CBER-2021-5683-1024840
<[email protected] >; Devlin, Carmel M <[email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<Laura.Got [email protected] >
Subject: [EXTERNAL] RE: STN 125742.0: Clinical IR RE document titled “bnt162- 01-interim3 -report -body”
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
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Good Morning Mike,
I’m writing to check in on CBER’s feedback regarding below. Please advise.
Best regards,
Elisa
From: Harkins Tull, Elisa
Sent: Tuesday, June 29, 2021 6:23 PM
To: Smith, Michael (CBER) < [email protected]
>; Aghajani Memar, Neda
<[email protected] >; Devlin, Carmel M <[email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laur a
<[email protected] >
Subject: RE: STN 125742.0: Clinical IR RE document titled “bnt162- 01-interim3 -report -body”
Hi Mike,
Our colleagues from BioNTech have the following request for clarifica tion/confirmation on this (Study
BNT162- 01 is conducted by BioNTech). Please advise.
We are providing and seeking clarification to your request in SNT 125742.0 dated 25 June 2021, clinical
final IR document, where you commented on the document “bnt162 -01-interim3 -report -body,” tables
14.3.1- 1.3-3, pages (1241/2151), titled “Frequency of subjects with solicited local reactions by grade -
BNT162b2.”
We have re -reviewed all solicited local and systemic reactogenicity data in the tables and have not
identif ied inconsistencies in the results from the older and younger subjects who received 30 mcg dose of
BNT162. Our analysis includes every solicited reaction of any severity for each subject, not just the worst
grade of solicited reaction per subject. Consequently, there may be more total events per symptom than number of subjects exposed.
Based on your request for clarification of the tables 14.3.1 -1.3-3, pages (1241/2151), we are anticipating
that CBER wishes us to provide new tables based on worst grade per participant per reactogenicity event
(solicited AEs), so as each participant is counted only once per symptom. We will accordingly plan to
submit new tables for solicited AEs (local and systemic) for the 7 days following each 30 mcg dose of the
investi gational vaccine based on the worst grade per symptom per participant by July 2
nd, as requested.
We would greatly appreciate confirmation or further clarification if our assumptions are correct.
Thank you.
FDA-CBER-2021-5683-1024841
Best regards,
Elisa
FDA-CBER-2021-5683-1024842