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BNT162b2
Module 1.14.1.5 Request for Waiver for Summary of Drug Utilization Rates
CONFIDENTIAL
Page 1REQUEST FOR WAIVER FOR SUMMARY OF DRUG UTILIZATION RATES
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Prescription Drug and Biological Products — Content and Format Draft Guidance for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 summary of drug utilization rates
among females of reproductive potential ( ie, aged 15 to 44 years) calculated cumulatively since
initial approval (if applicable).
Pfizer /BioNTech areproviding the justification below as it relates to Part V for the reason that
data on drug utilization rates in females o f reproductive potential 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 to prevent COVID- 19 in
individuals 16 y ears of age and o lder. Neither Pfizer nor BioNTech compiled data on drug
utilization rates among females of reproductive potential (ie, 15 to 44 y ears) for the reason
thatno clinical evidence existed at any point throughout clinical development to indicate that
vaccination posed an y elevated risk to women of this group.
The Advisory Committee on I mmunization Practices (ACI P) states: “Observational data
demonstrate that pregnant 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.
Additionally , they might be at an increased risk of adverse pregnancy outcomes, such as
preec lampsia, coagulopathy , and preterm birth. Data on the safet y of COVID -19 vaccines in
pregnant people are limited. No female reproduction or fetal, embry onal, or postnatal
development safety concerns were demonstrated in animals that received Pfizer -BioNTec h
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 can not cause
infection in either the mother or the fetus. No evidence exists of risk to the fetus from
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 request a waiver for the labeling
requirement to provide a summary of drug utilization rates among females of reproductive
potential.
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
090177e196d34a2b\Approved\Approved On: 20-Apr-2021 16:12 (GMT)
FDA-CBER-2021-5683-0779762
Document Approval Record
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090177e196d34a2b\Approved\Approved On: 20-Apr-2021 16:12 (GMT)
FDA-CBER-2021-5683-0779763