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FDA to fast-track COVID-19 vaccine

August 31, 2020

The chief of the FDA is willing to bypass the full federal approval process in order to make a COVID-19 vaccine available as soon as possible.

However, the move is not intended to please President Donald Trump, said FDA Commissioner Stephen Hahn. An emergency authorization could be appropriate before Phase Three clinical trials are completed “if the benefits outweigh the risks,” he added.

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the Financial Times. “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.”

The comments come a week after the FDA allowed emergency use of convalescent plasma to treat COVID-19 patients.

Already, China and Russia have each approved vaccines without waiting for the completion of phase three trials, which come with the most rigorous testing for a potential new drug. Public health officials in the U.S. and elsewhere have warned that the move could be unsafe.

“Our emergency use authorisation is not the same as a full approval,” Dr. Hahn said. He insisted that he would not rush a vaccine to please the president, amid reports that Mr. Trump wants a vaccine to be available before November’s election to help improve his chance of victory.

Selected tickers: Kamada (NASDAQ:KMDA), Grifols (NASDAQ:GRFS), XBiotech (NASDAQ:XBIT), Cerus (NASDAQ:CERS), ADMA Biologics (NASDAQ:ADMA).

https://seekingalpha.com/news/3609966-fda-to-fast-track-covidminus-19-vaccine-financial-times

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