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WorldPosted at: Aug 30 2020 7:54PM


US drug agency says COVID-19 vaccine may be authorized before end of phase 3 trials

Washington, Aug 30 (Sputnik) The US Food and Drug Administration (FDA) is ready to authorize a vaccine against COVID-19 before the end of phase three clinical trials if such a move proves to bring more benefits than risks, Stephen Hahn, the head of the FDA, told the Financial Times (FT) in an interview, which was published on Sunday.
At the moment, three pharmaceutical companies, namely AstraZeneca, Moderna and Pfizer, are conducting phase three trials in the United States, and President Donald Trump has said that vaccine could be approved in the country before the November 3 presidential election. Hahn told the FT that the FDA was ready to bypass the usual process for a vaccine authorization but would not do so just to please the president.
"It is up to the sponsor to apply for authorization or approval, and we make an adjudication of their application … If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination," Hahn said, adding that the FDA’s authorization was possible if "the benefit outweighs the risk in a public health emergency."
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