Document text
From: Gottschalk, Laura
Sent: Monday, July 26, 2021 2:06 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>
Subject: STN 125742/0: IR RE disposition of participant s in safety populations who experienced
pregnancy
Dear Ms. Harkins,
The review team has comments for you regarding the disposition of participants in safety populations
who experienced pregnancy. Please complete and submit the following table to your BLA by this Friday, July 30, 2021:
Table X: Disposition of Participants 16 Years of age and Older, Safety Populations who Experienced Pregnancy through 13 March 2021
Treatment Group BNT162b2
(N= )
n (%) Placebo
(N= )
n (%) Total
(N= )
n (%)
Total number of
pregnancies
Withdrawal from study
due to pregnancy
Timing of pregnancy
Completed 1 dose
Completed 2 doses
Completed 3 doses
Completed 4 doses
Spontaneous Abortions
Elective Abortions
Miscarriage
Fetal demise
Birth outcomes known
Unknown pregnancy
outcomes
Ongoing pregnancy
Major birth defect
Please provide the timing of the last dose (BNT162b2) , relative to LMP : study vaccination occurred prior
to LMP, within 30 days of LMP and >30 days after LMP. This may be expressed as a percentage of total pregnancies.
Please acknowledge receipt of this message and let me know if you have any questions.
FDA-CBER-2021-5683-1024714
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-2021-5683-1024715