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The FDA wants to speed up the coronavirus vaccine, says the head of the agency



The head of the US Food and Drug Administration (FDA) said on Sunday that he was ready to speed up the coronavirus vaccine in an attempt to make it as soon as possible.

In an interview with the Financial Times, Commissioner Stephen Hahn said the FDA was ready to authorize a vaccine before the end of a phase three clinical trial – “as long as staff believe the benefits outweigh the risks,” the paper said. He said the possibility did not involve any pressure from the Trump administration.

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“It depends on the sponsor [vaccine developer] to apply for a permit or approval and we make a decision on their application, “Hahn told the newspaper. “If they do it before the end of the third phase, we can consider it appropriate. We may consider this inappropriate, we will make a decision. “

In this scenario, Hahn said the FDA could grant urgent approval for specific groups, “not general approval,”

; for each outcome.

“Our emergency use permit is not the same as full approval,” Hahn said. “The legal, medical and scientific standard for this is that the benefits outweigh the risks of public health emergencies.”

The news comes after President Trump on August 22 accused the “deep state” of the FDA of making it difficult for pharmaceutical companies to test for coronavirus treatment – and suggested that the agency was trying to postpone it until after election day.

A day later, the FDA authorized emergency use, or EUA, for restorative plasma, a treatment for coronavirus that uses the blood plasma of recovered patients to help those still struggling with the disease.

But Khan was criticized after he grossly erred, then corrected claims about the life-saving power of plasma therapy for COVID-19, authorized by his agency. According to the Financial Times, Khan claims that the treatment could save the lives of 35 out of 100 patients, but according to reports, the data show that these estimates are closer to 5 out of 100 patients.

“I was criticized for remarks I made on Sunday night about the benefits of convalescent plasma. The criticism is completely justified. “What I had to say better was that the data showed a relative reduction in risk, not an absolute reduction in risk,” Hahn said on Twitter after facing criticism.

Khan told the Financial Times that he regretted “contributing to any misperceptions.”

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

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“We have a convergence of the COVID-19 pandemic with the political season and we will just have to go through that and stick to our basic principles. It will be science, medicine, a data solution. This will not be a political decision, “he added.

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


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