We need 30K people trialed to get EUA???
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Posted On: 08/24/2020 11:50:31 AM
In an article by Business Insider about trump wanting to fast-track a vaccine before election day, these statements were included by the reporter:
"In a bid to secure a coronavirus vaccine before November 3, Trump wants the US Food and Drug Administration to grant emergency use authorization to the vaccine being developed by Oxford University in the weeks leading up to the election, even if it does not yet have full regulatory approval, the Financial Times reports, citing unnamed sources.
The Oxford vaccine, being developed in partnership with the pharmaceutical firm AstraZeneca, is set to be trialed on 10,000 volunteers in the coming weeks; however, US health authorities have indicated a vaccine must be successfully trialed on 30,000 volunteers to receive authorization."
I've never heard of this 30K threshold being required for EUA. Has anyone else and could it hold up the application to the FDA?
"In a bid to secure a coronavirus vaccine before November 3, Trump wants the US Food and Drug Administration to grant emergency use authorization to the vaccine being developed by Oxford University in the weeks leading up to the election, even if it does not yet have full regulatory approval, the Financial Times reports, citing unnamed sources.
The Oxford vaccine, being developed in partnership with the pharmaceutical firm AstraZeneca, is set to be trialed on 10,000 volunteers in the coming weeks; however, US health authorities have indicated a vaccine must be successfully trialed on 30,000 volunteers to receive authorization."
I've never heard of this 30K threshold being required for EUA. Has anyone else and could it hold up the application to the FDA?
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