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- W4385406098 abstract "Abstract Context: Regulatory approaches to COVID-19 vaccine authorizations varied substantially across countries. Facing a common public health threat, what accounts for regulatory variation? This study focuses on emergency pharmaceutical and vaccine regulatory procedures, and whether and how regulators' emergency pharmaceutical regulatory procedures going into the pandemic shaped regulatory processes and decisions during the pandemic. Methods: An analysis of seven high-impact national and international pharmaceutical regulators, with case studies from Brazil, China, India, Russia, the United Kingdom, the United States, and the European Medicines Agency, and evidence from primary source executive and legislative branch regulations and statutes, national and international scientific and general press reporting, and secondary analysis of scholars, practitioners, and international organizations. Findings: Inherited emergency pharmaceutical and vaccine regulatory procedures substantially shaped COVID-19 vaccine regulation during the pandemic. Variation in the presence and content of emergency regulatory procedures affected the quality of pandemic regulatory processes, outcomes, and procedural updates, and differentially empowered policymaking experts and elected politicians. Conclusions: Emergency regulatory procedures affect key features of regulatory political economy and public health practices during crises. To improve future public health crisis responses, the authors provide sets of policy recommendations for 1) Establishing clear emergency pharmaceutical regulatory procedures, and 2) International collaboration." @default.
- W4385406098 created "2023-08-01" @default.
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- W4385406098 date "2023-07-31" @default.
- W4385406098 modified "2023-09-27" @default.
- W4385406098 title "Emergency Regulatory Procedures, Pharmaceutical Regulatory Politics, and the Political Economy of Vaccine Regulation in the COVID-19 Pandemic" @default.
- W4385406098 doi "https://doi.org/10.1215/03616878-10910278" @default.
- W4385406098 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37522337" @default.
- W4385406098 hasPublicationYear "2023" @default.
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