COVID19
US drug agency says COVID-19 vaccine may be authorized before end of phase 3 trials
Washington/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."
The FDA head also mentioned that the agency’s authorization for the emergency use of a potential vaccine did not equal its full approval.
At the same time, Hahn said that FDA’s decisions would be based on science and medicine, and not on politics or the upcoming election.
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