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FDA Could Green-Light COVID-19 Vaccines Before Clinical Trials Completed

MONDAY, Aug. 31, 2020 -- Emergency use authorization (EUA) or approval for a COVID-19 vaccine before phase 3 clinical trials are complete could be considered by the U.S. Food and Drug Administration, according to the agency's commissioner, Stephen Hahn, M.D.

"It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," he told the Financial Times, CNN reported. "If they do that before the end of phase 3, we may find that appropriate. We may find that inappropriate, we will make a determination." An EUA is not the same as full-fledged approval, Hahn noted. "Our emergency use authorization is not the same as a full approval," he said. "The legal, medical, and scientific standard for that is that the benefit outweighs the risk in a public health emergency."

Two vaccines are currently in phase 3 trials in the United States and two more are expected to begin phase 3 trials by mid-September, CNN reported.

Data, not politics, would guide any FDA decision on vaccines, according to Hahn. "We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," he said, CNN reported. "This is going to be a science, medicine, data decision. This is not going to be a political decision."

CNN Article

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