The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials
- PMID: 33306980
- PMCID: PMC7832518
- DOI: 10.1016/S1473-3099(20)30923-3
The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials
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.
Copyright © 2021 Elsevier Ltd. All rights reserved.
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References
-
- Vekemans J, Crofts J, Baker CJ, et al. The role of immune correlates of protection on the pathway to licensure, policy decision and use of group B Streptococcus vaccines for maternal immunization: considerations from World Health Organization consultations. Vaccine. 2019;37:3190–3198. - PMC - PubMed
-
- Pfizer Pfizer and Biontech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Nov 18, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-an...
-
- Gamaleya Research Institute of Epidemiology and Microbiology. Russian Direct Investment Fund The first interim data analysis of the Sputnik V vaccine against COVID-19 phase III clinical trials in the Russian Federation demonstrated 92% efficacy. Nov 11, 2020. https://sputnikvaccine.com/newsroom/pressreleases/the-first-interim-data...
-
- Moderna Moderna's COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the phase 3 COVE study. Nov 16, 2020. https://investors.modernatx.com/node/10316/pdf
-
- AstraZeneca AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19. Nov 23, 2020. https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr....
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