The FDA is Willing to Expedite Coronavirus Vaccine Process
The chief of the US Food and Drug Administration is willing to bypass full federal approval for the COVID-19 vaccine, according to CNBC.
FDA Commissioner Stephen Hahn insists that the Trump administration has not pressured the organization to expedite the vaccine process. He believes an emergency authorization would be justified before phase three clinical trials if the benefits outweigh the risks. “It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told The Financial Times. “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.”
Last week, the FDA granted emergency authorization of plasma treatments for COVID-19 patients in the hospital. President Trump has accused the FDA of dragging their feet with COVID-19 vaccines or treatments to hurt his political campaign. “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,” Hahn said.
“This is going to be a science, medicine, data decision,” he said. “This is not going to be a political decision.”
Emergency authorization of a vaccine would allow the vaccine to be used by certain groups before clinical trials are completed. “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.”
China and Russia have already approved vaccines without waiting for the completion of phase three trials. Public health officials have wanted that the move could be deemed unsafe.
The coronavirus has infected more than 6.1 million people in the US as of Sunday. The death toll has reached more than 187,000.