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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Analysis reveals signal detection tool in COVID-19 vaccine safety surveillance, indicating room for improvement in practices.

No de novo safety concerns detected using signal detection tool during the COVID-19 pandemic.
O/E analyses in vaccine monitoring facilitate detection of adverse events when data accuracy is ensured.
Regulatory authorities emphasized signal detection approaches for effective post-marketing surveillance strategies.
Industry experience highlights challenges and suggests standardizing methodologies to improve future applications.

Fretta et al. (2025) studied this question.

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