(300) 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

Publication Number: 974

Background: In December 2020, Pfizer-BioNTech received emergency use authorization (EUA) for a vaccine to prevent COVID-19. Although trials provided early insight into vaccine safety, evidence generation on real-world and longer-term safety was lacking. Within a week of EUA approval, HERO-Together launched, utilizing novel methods for streamlined enrollment and longitudinal data collection to efficiently monitor early and long-term safety.

Objectives: The objectives of HERO-Together are to determine incidence rates of adverse events of special interest and other clinically significant events following receipt of the Pfizer-BioNTech COVID-19 vaccine, and to evaluate for any excessive risk of events post-vaccination.

Methods: Participants were recruited from among existing HERO members (initially, an online community of healthcare workers that expanded to family and community members as vaccine eligibility expanded), as well as through marketing and point-of-vaccination efforts. HERO-Together is a fully remote prospective observational cohort study, conducted through an online portal. Individuals who received their first COVID-19 vaccine within the past 60 days self-enrolled and provided baseline data, and receive notifications to submit data at scheduled intervals for two years. Data elements include demographics, medical history, medications, COVID-19 infection, and safety events of interest, as well as quality-of-life assessments, well-being, and overall health. Automated reminders prompt participants who miss check-ins, with centralized call center outreach for non-responders. Medical records are obtained for reported safety events of interest, and events are evaluated based on Brighton Collaboration criteria.

Participants receive regular newsletters and result summaries, including from FDA interim reports. A HERO community newsfeed within the portal provides COVID news and information.

Results: HERO-Together enrolled 20,406 diverse individuals enrolled in nine months. Participants continue to contribute data to inform the longer-term safety of the COVID-19 vaccine.

Conclusions: Through novel, digitally-driven methods for enrollment and data collection, HERO-Together was able to quickly begin enrollment, making it the first safety study to launch and provide post-EUA safety information to regulators.