Lancet Infectious Diseases
Apr 2021 Volume 21 Number 4 p439-578, e67-e109
The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials
Jerome Amir Singh, Ross E G Upshur
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.