Novel Recruitment, Data Collection, and Safety Reporting Methods in the Era of COVID-19: Design of a Post-Emergency Use Authorization COVID-19 Vaccination Safety-Surveillance Study - Takeaways - MDSpire

Innovative Approaches to Participant Recruitment, Data Gathering, and Safety Monitoring During COVID-19: Framework for a Post-Emergency Use Authorization Study on Vaccination Safety Surveillance

  • By

  • Cherise Wong

  • Katherine Kendrick

  • Laura Webb

  • Lauren Cohen

  • M. Patricia McAdams

  • Heather Rubino

  • Patrick Caubel

  • Emily O'Brien

  • July 1, 2026

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  • 1

    The HERO Together study was launched to monitor the safety of the Pfizer-BioNTech COVID-19 vaccine post-emergency use authorization.

  • 2

    Initially, the study focused on healthcare workers, later expanding to include their families and community members as vaccine supply increased.

  • 3

    Recruitment strategies included digital promotion, partnerships with health organizations, and outreach at vaccination sites to enhance participation.

  • 4

    Participants self-enrolled through various mechanisms, including links sent via email to those who received their first vaccine dose.

  • 5

    The study aimed to determine incidence rates of adverse events following vaccination and evaluate any excessive risk associated with the vaccine.

Original Source(s)

Novel Recruitment, Data Collection, and Safety Reporting Methods in the Era of COVID-19: Design of a Post-Emergency Use Authorization COVID-19 Vaccination Safety-Surveillance Study

  • by Cherise Wong, Katherine Kendrick, Laura Webb, Lauren Cohen, M. Patricia McAdams, Heather Rubino, Patrick Caubel, Emily O'Brien

  • July 1, 2026

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