A Non-Interventional Post-Authorization Safety Study of Pfizer-BioNTech Bivalent COVID-19 Vaccine in the United States (US)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000314
• EU PAS number:
  EUPAS1000000314
• Study ID:
  1000000314
• Official title and acronym:
  A Non-Interventional Post-Authorization Safety Study of Pfizer-BioNTech Bivalent COVID-19 Vaccine in the United States (US)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This US non-interventional study will use secondary data from the Research Partners that contribute to the FDA Sentinel System to evaluate the incidence of safety events of interest and the incidence of pregnancy outcomes following receipt of the Pfizer-BioNTech bivalent COVID-19 Vaccine. A self-controlled risk interval design to assess general safety events (i.e., non-pregnancy related safety events of interest, including myocarditis/pericarditis) and a cohort design to assess pregnancy outcomes (spontaneous abortion, stillbirth, and preterm birth) and birth outcomes (major congenital malformations and small size for gestational age). ; ; Update: This study was terminated on 31-Jan-2025. The Pfizer-BioNTech bivalent COVID-19 Vaccine is no longer authorized for use in the US and safety studies of newer COVID-19 vaccine strains are expected sooner.
• Study status:
  Discontinued

Research institutions and networks

Institutions

Pfizer

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Harvard Pilgrim Health Care Institute

Study timelines

Date when funding contract was signed

Planned: 12/12/2022

Actual: 12/12/2022

Study start date

Planned: 30/09/2024

Actual: 30/09/2024

Data analysis start date

Planned: 01/01/2025

Date of final study report

Planned: 31/01/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Study protocol

Initial protocol

C4591051_PROTOCOL AMENDMENT 1_V2.0_06DEC2023.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C4591051