On Sunday, Stephen Hahn, the chief of the United States Food and Drug Administration (FDA), showed his willingness to fast-track a COVID-19 vaccine to make it available as early as possible. While speaking to the Financial Times, Commissioner Stephen Hahn states that the FDA agrees to authorize a coronavirus vaccine before the Phase Three clinical trials end. Given that the officials thought the benefits outweighed the risks also, according to the newspaper.
FDA Commissioner Stephen Hahn told the Financial Times he would be willing to fast-track the coronavirus vaccine process with an emergency use authorization for certain groups, but insisted he would not do so for political reasons. https://t.co/3wg0XcW1Qg
— Axios (@axios) August 30, 2020
Further, he said that the possibility did not associate with any pressure from the administration of Trump. Hahn explains the newspaper that it is over the sponsor vaccine developer to apply for approval or authorization, and if they make a decision of their application. If they do it before the Phase Three end, they may find that appropriate. Hahn says that the Food and Drug Administration may give emergency approval for specific groups other than a blanket approval in this scenario.
Trump accused the deep state FDA of thwarting efforts
Hahn says that their emergency use authorization is not the same as a complete approval. The medical, legal, and scientific standards for that benefit of vaccines outweigh the risk in a public health emergency. The news comes right after Donald Trump accused the deep state FDA of the COVID-19 vaccine’s awkward efforts, making it difficult for the drug firms to test COVID-19 treatments. Additionally, he blames that the agency is trying to delay them until after Election Day.
The FDA granted an emergency use authorization one day later for convalescent plasma, a COVID-19 treatment that uses the plasma from coronavirus recovered patients to help those in severe condition. According to the Financial Times, Hahn claimed that this treatment could save the lives of thirty-five out of a hundred patients. However, statistics supposedly show those estimations closer to five out of a hundred patients. Hahn wrote on Twitter about the criticism he faced for his remarks about the benefits of convalescent plasma.
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.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020