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BNT162b2
Module 1.14.1.5 Request for Waiver of Pregnancy Registry Report
CONFIDENTIAL
Page 1REQUEST FOR WAIVER OF PREGNANCY REGISTRY R EPORT
Part V of Pregnancy, Lactation, and Reproductive Potential: Labeling for Human
Prescription Drug and Biological Products — Content and Format Draft Guidance for
Industry dated July 2020 request s the Sponsor to file a n interim report of an ongoing registry
or a final report on a closed pregnancy registry (if applicable) or other study .
Pfizer /BioNTech areproviding the justification below as it relates to Part V for the reason that a
pregnancy exposure registry or report of another study is not available for BNT162b2).
BNT162b2 vaccine received Emergency Use Authorization (EUA 27034; Pfizer -BioNTech
COVID -19 Vaccine ) on 11 December 2020 for active immunization toprevent COVID -19 in
individuals 16 y ears of age and older . Neither Pfizer nor BioN Techcurrently maintain a
pregnancy exposure registry that evaluates obstetric, neonatal, and/or infant outcomes among
women vaccinated during pregnancy to prevent COVID -19.
The Advisory Committee on I mmunization Practices (ACI P) states : “Observational data
demonstrate that pre gnant people with COVID-19 have an increased risk of severe illness,
including illness resulting in intensive care admission, mechanical ventilation, extracorporeal
membrane ox ygenation, or death, though the absolute risk for these outcomes is low .
Additio nally , they might be at an increased risk of adverse pregnancy outcomes, such as
preeclampsia, coagulopathy , and preterm birth. Data on the safet y of COVID -19 vaccines in
pregnant people are limited. No female reproduction or fetal, embr yonal, or postnatal
development safety concerns were demonstrated in animals that received Pfizer -BioNTech
vaccine before or during gestation . Based on current knowledge, experts believe that
COVID -19 vaccines are unlikely to pose a risk to the pregnant person or the fetus because
the currently authorized COVID- 19 vaccines are non-replicating vaccines and cannot cause
infection in either the mother or the fetus. No evidence exists of risk to the fetus f rom
vaccinating pregnant women with non- replicating vaccines in general. However, the
potential risks of COVID -19 vaccines to the pregnant person and the fetus are unknown
because these vaccines have not been studied in pregnant people . Clinical trials to evaluate
the safet y and efficacy of COVID -19 vaccines in pregnant people are underway or planned.
Vaccine manufacturers are also following outcomes in people in the clinical trials who
became pregnant .”1
In accordance with 21 CFR 201.58 Pfizer /BioNTech re quest a waiver for the labeling
requirement to provide a pregnancy exposure registry report or other study report.
1Interim Clinical Considerations for Use of mRNA COVID- 19 Vaccines |
CDC . Available at:
www.cdc.gov/vaccines/covid -19/info- by-product/clinical -
considerations.html
Accessed on: March 17, 2021
090177e196d35d38\Approved\Approved On: 20-Apr-2021 16:13 (GMT)
FDA-CBER-2021-5683-0779764
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FDA-CBER-2021-5683-0779765