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From: Smith, Michael (CBER) < [email protected] >
Sent: Tuesday, March 8, 2022 3:38 PM
To: Collins, Kathleen Mary Catherine
Cc: Naik, Ramachandra < Ram [email protected] >; Gottschalk, Laura
<[email protected] >; Mineo, Gosia Harkins Tull, Elisa
<[email protected] >; Devlin, Carmel M < [email protected] >
Subject: RE: [EXTERNAL] RE: STN 125742/45 – Comirnaty sB LA – Clinical-statistic al comments regarding
updated immunobridging analyses and solicited adverse reaction frequencies
Kate,
I checked with the review team and the comment pertains to reactogenicity data
collected in the e-diary, as presented in Tables 5 and 6 of the draft package insert.
Regards,
Mike- Please confirm receipt of this email and let us know if you have any questions.
From: Collins, Kathleen Mary Catherine
Sent: Tuesday, March 8, 2022 2:05 PM
To:
Smith, Michael (CBER) < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Mineo, Gosia Harkins Tull, Elisa
<[email protected] >; Devlin, Carmel M < [email protected] >
Subject: [EXTERNAL] RE: STN 125742/45 – Comirnaty sBLA – Clinical-statistical comments regarding
updated immunobridging analyses and solicited adverse reaction frequencies
CAUTION: This email originated from outside of the organizatio n. Do not click links or open attachments unless you
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Thanks again Mike for the query.The team would like to clarify question 2 noted below: FDA Question: Please clarify whether additional solicited adverse reac tion data for adolescents
12 through 15 years of age in Study C4591001 have been collected up to the September 2, 2021
data cutoff since EUA issuance. Please submit updated solicited adverse reaction frequencies as appropriate, annotating any changes to the results.
In Study C4591001, in participants who originally received placebo, were unblinded (i.e. after
EUA issuance) and then received BNT162b2 after unblinding, events related to reactogenicity
were not reported using an e-diary but were instead reported as AEs. We would like clarify if Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0014080934, cn=Michael J. Smith -S4 Date: 2022.03.08 16:03:49 -05'00'
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500351
your question refers to reactogeni city data collected via the e-Diary or unsolicited AEs reported
to the investigators?
We look forward to your clarificati on on this question at your earliest.
Kind regardsKate
FDA-CBER-2022-5812-0500352