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

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:
  Finalised

Research institutions and networks

Institutions

Pfizer

Duke Clinical Research Institute (DCRI)

Verily Life Sciences, CVS Health Clinical Trial Services

Study timelines

Date when funding contract was signed

Planned:19/04/2023

Actual:19/04/2023

Study start date

Planned:30/06/2023

Actual:24/08/2023

Date of final study report

Planned:28/02/2026

Actual:05/02/2026

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