Stephen Hahn insisted he would not rush a vaccine to please the president, amid reports that Trump wants a vaccine to be available before the November election
“It is up to the sponsor to apply for authorization or approval, and we make an adjudication of their application,” Hahn said. “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.”
China and Russia have both approved vaccines without waiting for the end of Phase Three trials, which are the largest and most rigorous of all the tests that a potential new drug must undergo. But they have been criticized by public health officials — including ones in the US — who have warned that doing so could be unsafe.
“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.” “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. “This is going to be a science, medicine, data decision. This is not going to be a political decision.”Last Saturday, Trump accused “deep state” elements at the FDA of moving too slowly in approving new treatments for coronavirus in an effort to harm him politically.
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