Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47692
• EU PAS number:
  EUPAS42869
• Study ID:
  47692
• Official title and acronym:
  Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  This study aims to answer the question "Is the risk of pregnancy and infant safety outcomes increased among pregnant women in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry ("OTIS Pregnancy Registry") who were vaccinated with the Pfizer-BioNTech COVID-19 vaccine during pregnancy compared with those who did not receive any COVID-19 vaccine during pregnancy?" The study objective is to assess whether pregnant women who received the Pfizer-BioNTech COVID-19 vaccine during pregnancy experienced increased risk of pregnancy and infant safety outcomes, including major congenital malformations, spontaneous abortion, elective termination/abortion, stillbirth, preterm delivery, small for gestational age, and small for age postnatal growth at one year of age, relative to pregnant women who received no COVID-19 vaccines during pregnancy. This study is a prospective, observational cohort study of pregnancy and infant safety outcomes in pregnant women with exposure to the Pfizer-BioNTech COVID-19 vaccine using data from the OTIS Pregnancy Registry. The birth prevalence, incidence rates, and incidence proportion of pregnancy outcomes and incidence proportion of the infant outcome for women exposed to any dose of the Pfizer-BioNTech COVID-19 within one month prior to the first day of the last menstrual period to end of pregnancy will be compared to those observed in a comparator cohort unexposed to any COVID-19 vaccine during this period.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

University of California

Study timelines

Date when funding contract was signed

Planned: 06/05/2021

Actual: 06/05/2021

Study start date

Planned: 01/10/2021

Actual: 01/10/2021

Date of final study report

Planned: 28/02/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.

Study protocol

Initial protocol

C4591022_PROTOCOL AMENDMENT 1_20AUG2021

Updated protocol

C4591022_PROTOCOL AMENDMENT 3_V4_09MAY2022

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)