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

Purpose: Within one week of the Food and Drug Administration granting the COVID-19 vaccine Emergency Use Authorization, the HERO-Together study launched. We describe how the study utilized novel methods for streamlined enrollment and longitudinal data collection to efficiently monitor early and long-term safety of the COVID-19 vaccine. Methods: HERO-Together is a fully remote, prospective observational cohort study, conducted through an online portal. Participants were recruited from an existing 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. Individuals received notifications to submit data at scheduled intervals for two years, and automated reminders prompted participants with missed check-ins, with centralized call center outreach for non-responders. Results: Multiple recruitment approaches were adopted, including direct outreach, national and local media campaigns, downloadable enrollment toolkits (e.g., social media), social media influencer partnerships, and pharmacy referrals. A study population of n = 19, 858 was enrolled within nine months of emergency use authorization, most self-reporting as white, female, working in healthcare, and all for whom variable survey completion was observed. Conclusion: Collectively, diverse recruitment strategies, data collection through the online portal, and electronic consent enabled rapid, decentralized enrollment of study participants in order to remotely monitor COVID-19 vaccine safety during the early days of the pandemic. Trial Registration: EUPAS38671.

Duke Scholars

Author Emily O'Brien Population Health Sciences