The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials.

Lancet Infect Dis

Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.

Published: April 2021

AI Article Synopsis

  • The development of an effective COVID-19 vaccine is the top research priority globally.
  • Many countries are open to granting emergency use or conditional approval for a vaccine even before it is fully licensed, based on public health needs.
  • If candidate vaccines receive emergency authorization and are used before completing phase 3 trials, it could significantly impact vaccine research and the management of the COVID-19 pandemic.

Article Abstract

An efficacious COVID-19 vaccine is currently the world's leading research priority. Several nations have indicated that if there is a compelling case for use of a vaccine before it is licensed, they would be prepared to authorise its emergency use or conditional approval on public health grounds. As of Dec 1, 2020, several developers of leading COVID-19 candidate vaccines have indicated that they have applied, or intend to apply, for emergency authorisation for their vaccines. Should candidate vaccines attain emergency use designation and be programmatically deployed before their phase 3 trials conclude, such a strategy could have far reaching consequences for COVID-19 vaccine research and the effective control of the COVID-19 pandemic. These issues merit careful consideration.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832518PMC
http://dx.doi.org/10.1016/S1473-3099(20)30923-3DOI Listing

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