Study identification

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
First published:
01/02/2024
Institution
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner

Contact details

Jenny Sun

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable