Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada
- PMID: 34170306
- PMCID: PMC8233699
- DOI: 10.1001/jamanetworkopen.2021.14531
Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada
Abstract
This qualitative improvement study investigates COVID-19 vaccine approvals at 3 medicine regulatory agencies in the US, EU, and Canada, characterizing and contrasting regulatory review times, and analyzing the clinical evidence supporting authorization.
Conflict of interest statement
References
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- US Food and Drug Administration. Development and licensure of vaccines to prevent COVID-19. June 2020. Accessed March 17, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...
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- Government of Canada. Vaccines and treatments for COVID-19: progress. Accessed April 21, 2021. https://www.canada.ca/en/public-health/services/diseases/2019-novel-coro...
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