[ad_1]
The head of the United States Food and Drug Administration (FDA) said on Sunday that he is willing to accelerate 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, “provided officials believe that the benefits outweigh the risks,” the newspaper reported. He said the possibility was not linked to any pressure from the Trump administration.
MANDATORY CORONAVIRUS VACCINATION IN THE US IS NOT LIKELY, SAYS FAUCI
“Depends on the sponsor [vaccine developer] to request authorization or approval, and we award your request, ”Hahn told the newspaper. “If they do it before the end of Phase Three, we can consider it appropriate. We may consider it inappropriate, we will make a determination. “
In this scenario, Hahn said that the FDA can grant an emergency approval for specific groups “instead of a blanket approval,” according to 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 FDA’s “deep state” of making it difficult for drug companies to test coronavirus treatments, and suggested that the agency is trying to delay them until after Monday. elections.
A day later, the FDA granted an Emergency Use Authorization, or EUA, for convalescent plasma, a treatment for coronavirus that uses the blood plasma of recovered patients to help those still battling the disease.
But Hahn came under fire after he made an erroneous statement, then corrected, claims about the power of a plasma therapy for COVID-19 authorized by his agency to save lives. According to the Financial Times, Hahn claimed that the treatment could save the lives of 35 out of 100 patients, but data shows those estimates are closer to 5 out of 100 patients.
“I have been criticized for the comments I made Sunday night about the benefits of convalescent plasma. The criticism is fully justified. What I should have said better is that the data shows a relative reduction in risk, not an absolute reduction in risk, ”Hahn said on Twitter after facing criticism.
Hahn told the Financial Times that he regrets “having contributed to any misperceptions.”
“I could have done a much better job last Sunday explaining the relative risks,” he continued.
CLICK HERE TO SEE THE FOX NEWS APP
“We have a convergence of the COVID-19 pandemic with the political season, and we will just have to get past that and stick to our core principles. This will be a science, medicine and data decision. This is not going to be a political decision, “he added.
Adam Shaw of Fox News and the Associated Press contributed to this report.
