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MONDAY, Aug. 31, 2020 (HealthDay News) — 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.<\/p>\n
“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<\/i>, CNN<\/i> 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.”<\/p>\n
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<\/i> reported.<\/p>\n
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<\/i> reported. “This is going to be a science, medicine, data decision. This is not going to be a political decision.”<\/p>\n