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The US is not ruling out the approval of a vaccine before the end of Phase 3 trials

August 30, 2020

The United States’ Food and Drug Administration (FDA) commissioner Stephen Hahn has confirmed they are not ruling out the approval of emergency use of a coronavirus vaccine before the end of phase 3 trials.

“It is up to the developer if he requests an authorization and then an authorization is given to use it,” said Hahn in an interview with the Financial Times. “If they do it before Phase 3 is over, we may or may not think it’s appropriate. Then we’ll make up our minds,” he said.

“The legal, medical and scientific criterion is whether the benefit in the midst of a health emergency is much greater than the risk,” he argued, declining that it was a political criterion. “The COVID-19 pandemic coincides with the political season and we must overcome it and stick to our principles,” he said.

The US is not ruling out the approval of a vaccine before the end of Phase 3 trialsThe US is not ruling out the approval of a vaccine before the end of Phase 3 trials

In any case, it would be an emergency authorization that is far from full validation by the FDA, the head of the FDA has pointed out.

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