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From: Gottschalk, Laura <[email protected]>
Sent: Friday, August 20, 2021 1:51 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik,
Ramachandra <[email protected]>
Subject: STN 125742/0 : 7th set of PI labeling comments and request for table with subjects who
reported unsolicited AEs during blinded follow -up in study C4591001 - Please respond by COB Today
Dear Elisa,
Attached is the 7
th set of comments from the review team on the Package Insert (PI). Additionally, we
have the following information request:
Please complete the following table to summarize the numbers and percentages of BNT162b2 and placebo recipients, by age group and study period, who reported the indicated categories of unsolicited
adverse events du ring blinded follow -up in study C4591001. Please use denominators of the
corresponding population in each column and please do not report percentages in 100/PY. .
EVENT BNT162b2
≥16- 55
n/N (%) BNT162b2
>55 years
n/N (%) Total
BNT162b2
≥16 years
n/N (% ) Placebo
≥16- 55
n/N (%) Placebo
>55
years
n/N (%) Total
Placebo
≥16
years
n/N (%)
From Dose
1 through
1 month
Dose 2
Any
unsolicited
adverse
event
Unsolicited
non-
serious AEs
SAEs
Withdrawal
due to
unsolicited
AEs
Death
From Dose
1 to cutoff
date or participant
unblinding
FDA-CBER-2021-5683-1024838
(whichever
is earlier)
Any
unsolicited
adverse
event
Unsolicited
non-
serious AE
SAEs
Withdrawal
due to
unsolicited
AEs
Deaths
Please email us the further revised PI (both Word tracked- changes and Word annotated) and completed
table by COB today, August 20, 2021, and follow up with a submission to the BLA.
Please acknowledge receipt of this communication and let me know if you ha ve any questions.
Best,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
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FDA-CBER-2021-5683-1024839