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fast-track willing

FDA willing to fast-track coronavirus vaccine, agency chief says – Fox News

The head of the U.S. Food and Drug Administration (FDA) said on Sunday that he is willing to fast-track a coronavirus vaccine in an effort to make it available as soon as possible.

Speaking to the Financial Times, Commissioner Stephen Hahn said the FDA is willing to authorize a vaccine before the end of Phase Three clinical trials – “as long as officials believed the benefits outweighed the risks,” the newspaper reported. He said the possibility was not linked to any pressure from the Trump administration.

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“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 newspaper. “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.”

In this scenario, Hahn said the FDA may grant emergency approval for specific groups “rather than a blanket approval,” per the outlet.

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

The news comes after President Trump on Aug. 22 accused the “deep state” at the FDA of making it hard for drug companies to test coronavirus treatments – and suggested the agency is trying to delay them until after Election Day.

A day later, the FDA granted an emergency use authorization, or EUA, for convalescent plasma, a coronavirus treatment that uses the blood plasma from recovered patients to help those who are still battling the disease.

But Hahn was criticized after he grossly misstated, then corrected, claims about the lifesaving power of a plasma therapy for COVID-19 authorized by his agency. Per the Financial Times, Hahn claimed the treatment could save the lives of 35 out of 100 patients, but data reportedly shows those estimates are closer to 5 out of 100 patients.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction,” Hahn said on Twitter after facing criticism.

Hahn told the Financial Times that he regrets “contributing to any misperception.”

“I could have done a much better job last Sunday explaining relative risks,” he continued.

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“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,” he added.

Fox News’s Adam Shaw and the Associated Press contributed to this report. 

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fast-track willing

FDA willing to fast-track COVID-19 vaccine before end of Phase Three trials – New York Post

August 31, 2020 | 6:53am | Updated August 31, 2020 | 11:00am

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 of 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 an 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 about it is still too weak.

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.

Dr. Stephen Hahn
Dr. Stephen HahnAP

“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.”

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