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

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

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.

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Article Information

Accepted for Publication: April 22, 2021.

Published: June 25, 2021. doi:10.1001/jamanetworkopen.2021.14531

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Lythgoe MP et al. JAMA Network Open.

Corresponding Author: Mark P. Lythgoe, MBBS, Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, Du Cane Rd, W12 0HS, London (M.Lythgoe@imperial.ac.uk).

Author Contributions: Drs Lythgoe and Middleton had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Lythgoe.

Acquisition, analysis, or interpretation of data: Both authors.

Drafting of the manuscript: Lythgoe.

Critical revision of the manuscript for important intellectual content: Both authors.

Administrative, technical, or material support: Middleton.

Supervision: Lythgoe.

Conflict of Interest Disclosures: None reported.

References
1.
Avorn  J , Kesselheim  A .  Regulatory decision-making on COVID-19 vaccines during a public health emergency.   JAMA. 2020;324(13):1284-1285. doi:10.1001/jama.2020.17101PubMedGoogle ScholarCrossref
2.
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/development-and-licensure-vaccines-prevent-covid-19
3.
Downing  NS , Aminawung  JA , Shah  ND , Krumholz  HM , Ross  JS .  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.   JAMA. 2014;311(4):368-377. doi:10.1001/jama.2013.282034PubMedGoogle ScholarCrossref
4.
Puthumana  J , Egilman  AC , Zhang  AD , Schwartz  JL , Ross  JS .  Speed, evidence, and safety characteristics of vaccine approvals by the US Food and Drug Administration.   JAMA Intern Med. 2021;181(4):559-560. doi:10.1001/jamainternmed.2020.7472PubMedGoogle ScholarCrossref
6.
European Medicines Agency. International cooperation to align approaches for regulation of COVID-19 vaccines and medicines. Accessed March 17, 2021. https://www.ema.europa.eu/en/news/international-cooperation-align-approaches-regulation-covid-19-vaccines-medicines
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