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FDA willing to fast-track coronavirus vaccine, agency chief says
By Madeline Farber
Published August 31, 2020
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.
https://www.foxnews.com/health/fda-coronavirus-vaccine-fast-track