• Lancet Infect Dis · Apr 2021

    Review

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

    • Jerome Amir Singh and Upshur Ross E G REG Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada..
    • Howard College School of Law, University of Kwazulu-Natal, Durban, South Africa; Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. Electronic address: singhj9@ukzn.ac.za.
    • Lancet Infect Dis. 2021 Apr 1; 21 (4): e103-e109.

    AbstractAn 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.Copyright © 2021 Elsevier Ltd. All rights reserved.

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