MONDAY, Aug. 31, 2020 (HealthDay News) — Emergency use authorization or approval for a COVID-19<\/a> vaccine<\/a> before Phase 3 clinical trials<\/a> are complete could be considered by the U.S. Food and Drug Administration, according to the agency’s commissioner, Dr. Stephen Hahn.<\/p>\n “It is up to the sponsor [vaccine<\/a> developer] to apply for authorization or approval, and we make an adjudication of their application,” he told the Financial Times<\/i>, CNN<\/i> reported.<\/p>\n “If they do that before the end of Phase Three, we may find that appropriate,” Hahn added. “We may find that inappropriate, we will make a determination.”<\/p>\n An EUA isn’t the same as full-fledged approval, Hahn noted.<\/p>\n “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<\/a> 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<\/a>, according to Hahn.<\/p>\n “We have a convergence of the COVID-19<\/a> 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 ![\"MedicalNews\"](\"https:\/\/images.medicinenet.com\/images\/HealthDay\/healthday.png\")
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