HERO-Together: A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine in US healthcare workers, their families, and their communities

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46811
• EU PAS number:
  EUPAS38671
• Study ID:
  46811
• Official title and acronym:
  HERO-Together: A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine in US healthcare workers, their families, and their communities
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is a prospective observational study designed to evaluate the incidence rates of safety events of interest and other clinically significant events within a cohort of healthcare workers, their families, and their communities who receive the Pfizer-BioNTech COVID-19 vaccine under the EUA program in the United States. The study is a primary data collection study with review of medical records. Receipt of the vaccine is required for inclusion in the study, but the decision to be vaccinated is made at the discretion of the recipient. This study will aim to enroll and follow 20,000 vaccinated healthcare workers and members of their families or communities during a 30-month study period. Information on hospitalization and diagnosis of safety events of interest will be collected from participant self-report at regular intervals following vaccination, primarily using a secure web portal. Participant reports of safety events of interest and/or hospitalization trigger a request for and review of participant medical record information for adjudication of the event. To address the primary objective, incidence rates of safety events will be estimated based on cases confirmed by adjudication. To address the secondary objective regarding assessment of increased risk, a self-matched comparative analysis will be undertaken for feasible safety events (e.g. events with a known risk interval and sufficient case counts). Additional context for the rates observed in vaccinated individuals will be sought from population background rates.
• 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: 14/12/2020

Actual: 14/12/2020

Study start date

Planned: 17/12/2020

Actual: 17/12/2020

Date of final study report

Planned: 31/12/2023

Actual: 07/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591008 v1 16Dec2020 Non-Interventional Post Authorization Safety Study (PASS) Protocol

Updated protocol

C4591008_PROTOCOL AMENDMENT 3_17AUG2023

Regulatory

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