The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective

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Observational analysis shows challenges in signal detection for vaccine safety, suggesting best practices for future refinement.

Rapid signal detection for COVID-19 vaccine safety required unconventional observed-to-expected analyses.
Despite efforts, no new safety concerns were identified through these methods, indicating limitations in data confidence.
A dedicated working group reviewed experiences of Marketing Authorization Holders using O/E analyses during the pandemic.
Industry insights highlight the need for standardized methodologies to improve vaccine safety monitoring protocols.

Fretta et al. (2025) studied this question.

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