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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to CBER 26July 2021 Information Request Regarding Disposition of
Participants in Safety Populations Who Experienced Pregnanc y
July2021
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FDA-CBER-2021-5683-0950146
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 2LIST OF ABBREVIATIONS
Abbreviation Term
BLA Biologics License Application
CBER Center for Biologics Evaluation and Research
COVID-19 coronavirus disease 2019
CRF Case report form
EDP Exposure during pregnancy
FDA Food and Drug Administration
LMP Last menstrual period
mRNA messenger ribonucleic acid
OVRR Office of Vaccines Research and Review
SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 31.INTRODUCTION
Reference is made to BLA STN 125742/0 for COVID- 19 mRNA Vaccine (COMI RNATY),
for active immunization to prevent COVID -19 caused by SARS-CoV-2 in individuals
≥16years of ageand to CBER’s 26 July 2021 Information Request received via email from
Laura Gottschalk, PhD, CBER ,OVRRregarding the disposition of participants in safet y
populations who experienced pregnancy .
CBER’s request in bold italics isfollowed by Pfizer/BioNTech’s re sponse below.
2.CBERREQUEST AND PFIZER/ BIONTECH’S RESPONSE
CBERRequest
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 GroupBNT162b2
(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.
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 4Pfizer/BioNTech Response
Pfizer/BioNTech have provided the requested information available, including the timing of
the last dose (BNT162b2), relative to pregnancy (pregnancy defined as the conception date
established by ultrasound ,or in the absence of ultrasound, estimated from the LMP),in Table
1and Table 2below.Pfizer/BioNTech have not included information on Unknown
pregnancy outcomes, Birth outcomes known and Ongoing pregnancyin th e programmed
tablessince these dataare not collected as standard in the clinical database (birth outcomes
are only collected in the safet y database if the site becomes aware of it and updates the
pregnancy report). All EDP events logged on the CRF will h ave the outcome of unknown
entered as per the CRF completion guidelines when first logged so it would not give a true
reflection of what Pfizer/BioNTech know about the outcomes andsimilarly it would not give
a true reflection of ongoing pregnancies .
At the time of the data cutoff date (13March 2021 ), a total of 50participants who had
received BNT162b2 had reported pregnancies, including 42 participants originally
randomized to theBNT162b2 group and 8 participants originall y randomized to theplacebo
group who then rece ived BNT162b2 ( Module 5.3.5.1 C4591001 I nterim Report Body – 6
month update, Section 12.2.4.5.2 ). In Table 1, the BNT162b2 column includes the 42
participants originally randomized to the BNT162b2 group. In Table 2, the BNT162b2
column includes the 8 participants who were originally randomized to the placebo group who
then received BNT162b2.
Table 1. Disposition of Participants 16 Years of age and Older, Phase 2/3, Safety
Populations who Experienced Pregnancy through 13 March 2021
BNT162b2a
(N=22026)
n (%)Placebob
(N=22021)
n (%)Total
(N=44047)
n (%)
Total number of pregnancies 42 (0.2) 47 (0.2) 89 (0.2)
Withdraw al from vaccination due to pregnancy 5 (0.0) 5 (0.0) 10 (0.0)
Timing of pregnancy
Completed 1 dose 5 (0.0) 8 (0.0) 13 (0.0)
Completed 2 doses 37 (0.2) 39(0.2) 76 (0.2)
Timing of last dose relative to pregnancy
Within 30 days of pregnancy 13 (0.1) 21 (0.1) 34 (0.1)
>30 days after pregnancy 29 (0.1) 26 (0.1) 55 (0.1)
Spontaneous Abortions 3 (0.0) 7 (0.0) 10 (0.0)
Miscarriages 3 (0.0) 5 (0.0) 8 (0.0)
Elective Abortions 0 1 (0.0) 1 (0.0)
Fetal demise 0 0 0
Major birth defects 0 0 0
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary
a. Includes data from Dose 1 through 13 March 2021 for participants who originally received BNT162b2.
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 5Table 1. Disposition of Participants 16 Years of age and Older, Phase 2/3, Safety
Populations who Experienced Pregnancy through 13 March 2021
BNT162b2a
(N=22026)
n (%)Placebob
(N=22021)
n (%)Total
(N=44047)
n (%)
b. Includes data from Dose 1 to before the first dose of BNT162b2 or through 13 March 2021 for participants
who originally received placebo.
PFIZER CONFID ENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation:
29JUL2021 (12:23)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output
File: ./nda2_unblinded/C4591001_BLA_RR/preg_p23_ge16
Table 2.Disposition of Participants 16 Years of age and Older Who Originally
Received Placebo and Then Received BNT162b2 After Unblinding, Phase
2/3, Safety Populations who Experienced Pregnancy through 13 March
2021
BNT162b2a
(N=19611)
n (%)
Total number of pregnancies 8 (0.0)
Withdraw al from vaccination due to pregnancy 3 (0.0)
Timing of pregnancy
Completed 1 dose 3 (0.0)
Completed 2 doses 5 (0.0)
Timing of last dose relative to pregnancy
Within 30 days of pregnancy 7 (0.0)
>30 days after pregnancy 1 (0.0)
Spontaneous Abortions 0
Miscarriages 0
Elective Abortions 0
Fetal demise 0
Major birth defects 0
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary
a. Includes data from first dose of BNT162b2 through 13 March 2021 for subjects who originally received
placebo and then received BNT162b2 after unblinding.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation:
29JUL2021 (12:23)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output
File: ./nda2_unblinded/C4591001_BLA_RR/preg_p23_xover
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FDA-CBER-2021-5683-0950150
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