The head of the US Foods and Drug Administration Mr. Hahn declared important news last Sunday. He said that they would fast track the coronavirus vaccine’s availability to everyone as earlier than possible.
Commissioner Stephen Hahn has given the word to the Financial Times that FDA will allow a coronavirus vaccine before the end of phase 3 clinical trials. The newspaper reported that the benefits outweighed the risks as long as officials believed the same.
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Speaking to the major newspapers, Hahn said that “it is up to the sponsor to apply for authorization for approval, and we make an adjudication of their application. If they do that before the end of phase 3, we may find that appropriate. We may find that in appropriate, we will make a determination.”
Hahn also said that the FDA might grant emergency approval for specific groups per the outlet.
“Our emergency use authorization is not the same as a full approval. The legal, medical, and scientific standard for that is that the benefit outweighs the risk in a public health emergency”. Hahn added.
On August 22nd, President Trump suggested the agencies to delay testing of coronavirus treatments until after Election Day. The very next day, the FDA granted an emergency use of authorization to treat using the coronavirus vaccine. For that, they used the blood plasma from the recovered patients.
Hahn gave an assurance about this treatment. He claimed that this treatment could save the lives of 35 out of 100 patients.
“They have criticized me 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 tweeted after the criticism.
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