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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.

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Τίτλος: 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.
Συγγραφείς: Wong C; Pfizer Inc., Worldwide Safety, New York, New York, USA., Kendrick K; Pfizer Inc., Worldwide Safety, New York, New York, USA., Webb L; Duke Clinical Research Institute, Durham, North Carolina, USA., Cohen L; Duke Clinical Research Institute, Durham, North Carolina, USA., McAdams MP; Duke Clinical Research Institute, Durham, North Carolina, USA., Rubino H; Pfizer Inc., Worldwide Safety, New York, New York, USA., Caubel P; Pfizer Inc., Worldwide Safety, New York, New York, USA., O'Brien E; Duke Clinical Research Institute, Durham, North Carolina, USA.; Duke University School of Medicine, Durham, North Carolina, USA.
Πηγή: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2026 Jul; Vol. 35 (7), pp. e70431.
Τύπος έκδοσης: Journal Article; Observational Study
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print Cited Medium: Internet ISSN: 1099-1557 (Electronic) Linking ISSN: 10538569 NLM ISO Abbreviation: Pharmacoepidemiol Drug Saf Subsets: MEDLINE
Imprint Name(s): Original Publication: Chichester, West Sussex : Wiley, 1992-
Ιατρικοί όροι (MeSH): COVID-19 Vaccines*/adverse effects , COVID-19 Vaccines*/administration & dosage , COVID-19*/prevention & control , COVID-19*/epidemiology , Product Surveillance, Postmarketing*/methods , Data Collection*/methods , Emergency Use Authorization* , Patient Selection* , Adverse Drug Reaction Reporting Systems*, United States/epidemiology ; Humans ; Prospective Studies ; Female ; Male ; Adult ; Middle Aged ; Vaccination
Περίληψη: 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.
(© 2026 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)
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Grant Information: Pfizer
Contributed Indexing: Keywords: COVID‐19 vaccine; observational; recruitment; remote; safety
Local Abstract: [plain-language-summary] The HERO‐Together study started within a week of the COVID‐19 vaccine receiving Emergency Use Authorization in the United States, aiming to quickly and efficiently monitor both short‐ and long‐term safety. The study was fully online, which made it easy to join and participate from home. Participants first included healthcare workers and later expanded to their families and community members as more people became eligible for the COVID‐19 vaccine. Participants were recruited through an existing online community, through marketing efforts, and at vaccination sites. Nearly 20 000 participants joined the study within 9 months of vaccine launch; most were white, female, and worked in healthcare. Participants were asked to complete online surveys regularly for 2 years. Automated reminders were sent to encourage survey completion, and call center staff followed up with those who did not respond.
Substance Nomenclature: 0 (COVID-19 Vaccines)
Entry Date(s): Date Created: 20260712 Date Completed: 20260712 Latest Revision: 20260726
Update Code: 20260726
PubMed Central ID: PMC13357033
DOI: 10.1002/pds.70431
PMID: 42437699
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1099-1557
DOI:10.1002/pds.70431