FDA willing to fast-track COVID-19 vaccine before end of Phase Three trials

The head of the US Food and Drug Administration is willing to fast-track a coronavirus vaccine as quickly as possible – even before Phase Three clinical trials end — as long as officials are convinced the benefits outweigh the risks, according to a report.

Commissioner Stephen Hahn told the Financial Times that the move would not be a result from any pressure from Team Trump to roll out COVID-19 vaccines as a means to increase the president’s re-election chances.

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

President Trump recently accused members of a so-called “deep state” working within the FDA of slow-walking vaccines and treatments for the coronavirus to hurt his re-election bid against Joe Biden in November.

A day later, the FDA issued emergency use authorization, or EUA, of convalescent plasma as a treatment that uses blood plasma from recovered patients, despite concerns among some health experts that data is still too weak about it.

Hahn was promptly assailed for overstating the benefits of convalescent plasma when he said the treatment would have saved the lives of 35 out of 100 patients. The figure is closer to 5 out of 100, data suggest.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn said in a tweet.

“What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he added.

The FDA chief told the Financial Times that a vaccine EUA could be used to safely make it available to certain groups before clinical trials are completed.

“Our emergency use authorization is not the same as a full approval,” Hahn told the outlet. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”

He added: “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. This is going to be a science, medicine, data decision. This is not going to be a political decision.”

Share this article:

Source: Read Full Article