Study identification

EU PAS number

EUPAS105791

Study ID

106796

Official title and acronym

HERO-Together Boost: A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine

DARWIN EU® study

No

Study countries

United States

Study description

The research question addressed by this study is: what are the incidence rates of safety events of interest among persons vaccinated with the Pfizer-BioNTech COVID 19 vaccine in a United States (US) cohort? The primary study objective is to estimate the real-world incidence of safety events of interest among recipients of the Pfizer-BioNTech COVID-19 vaccine following Emergency Use Authorization (EUA). The secondary objective is to estimate the incidence rates of safety events of interest among subcohorts of interest, including individuals who are pregnant, individuals who are immunocompromised, and stratified by age. This is a prospective observational cohort study of US residents, in which data are collected from participant self-report at regular intervals following vaccination, primarily using a secure web portal. Safety event occurrence will be confirmed by medical record review and/or linked claims/electronic health record (EHR) data. The study period will be 18 months.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Verily Life Sciences, CVS Health Clinical Trial Services

Contact details

Cherise Wong

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable