Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices

Background incidence rates (BIRs) are essential for contextualizing adverse event rates in vaccine safety monitoring, particularly through observed-to-expected (O/E) analyses. The unprecedented rapid development of vaccines during the coronavirus disease 2019 (COVID-19) pandemic necessitated rigorou...

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Κύριοι συγγραφείς:	Sonja Gandhi-Banga, Laurence Serradell, Deborah Layton, Jill Dreyfus, Nicolas Praet, Diana C. Garofalo, Vincent Bauchau, Scott P. Kelly, Lin Li
Μορφή:	Artigo
Γλώσσα:	Inglês
Έκδοση:	Frontiers Media S.A. 2025-12-01
Σειρά:	Frontiers in Drug Safety and Regulation
Θέματα:	adverse events of special interest background incidence rates best practices electronic healthcare databases safety monitoring COVID-19 vaccine
Διαθέσιμο Online:	https://www.frontiersin.org/articles/10.3389/fdsfr.2025.1651090/full
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