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Course: Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada

CME Credits: 1.00

Released: 2021-06-25

On the 1-year anniversary of the World Health Organization (WHO) declaring COVID-19 a global pandemic, the development and rollout of safe and effective vaccines has fueled optimism for greater pandemic control. During the COVID-19 pandemic, medicine regulators have faced significant pressure from both the public and governments to expedite vaccine approval, while grappling with the challenges of novel vaccine clinical development and ensuring public trust and confidence in COVID-19 vaccines.1 Recognizing the gravity of this public health emergency, medicine regulators have introduced or activated accelerated mechanisms for restricted approval or permitted use of unapproved medical products in predefined circumstances (eg, Emergency Use Authorizations [EUA]).2 We investigated COVID-19 vaccine approvals at 3 medicine regulatory agencies, the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada (HC), characterized and contrasted regulatory review times, and analyzed the clinical evidence supporting authorization.


Educational Objective
To identify the key insights or developments described in this article


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