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

Author:

Lythgoe Mark P.1,Middleton Paul2

Affiliation:

1. Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, United Kingdom

2. Department of Metabolism, Digestion and Reproduction, Imperial College London, St Mary’s Hospital, United Kingdom

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference6 articles.

1. Regulatory decision-making on COVID-19 vaccines during a public health emergency.;Avorn;JAMA,2020

2. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.;Downing;JAMA,2014

3. Speed, evidence, and safety characteristics of vaccine approvals by the US Food and Drug Administration.;Puthumana;JAMA Intern Med,2021

4. 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

5. 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-coronavirus-infection/prevention-risks/covid-19-vaccine-treatment.html#a2

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