FDA To Bypass Federal Approval for Emergency Authorization of COVID19 Vaccines

The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, reports CNBC

Emergency Authorization Needed?

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed 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.”

Not A Political Decision?

The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized Covid-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support the widespread application of the treatment yet. That announcement was on the heels of President Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.

Hahn told the Financial Times that he wouldn’t rush a vaccine solely to please Trump.

“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.”

He said emergency authorization could be used to safely make the vaccine available for use 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.”

Scott Gottlieb, former FDA chief, said Sunday on CBS’ “Face the Nation” that he’s uncertain what Hahn meant.

“I’m not sure what he means by approving it earlier than when the trials are completed,” Gottlieb said. “They are going to wait for these trials to read out before they can make a decision around the efficacy of these vaccines.”

He said it’s likely that data from phase three trials would come out in November. However, he said as the trials progress, if the results show the vaccine is very effective, that could be October.

Nevertheless, he expects the first approvals to be done on an emergency basis and targeted at groups that may be at more risk for infection or a bad outcome.

“A full approval for the general population — when people can go to CVS and get a shot — that’s really a 2021 event,” Gottlieb said.

Previous Authorization Rumors

Last week, The Financial Times reported that the Trump administration was considering an emergency use authorization before the presidential election for an experimental coronavirus vaccine developed in the U.K. by Oxford University and AstraZeneca.

At the time, a spokesperson for the Department of Health and Human Services, which includes the FDA, said any reports about an emergency authorization for a vaccine prior to the election were “absolutely false.” AstraZeneca said it had not discussed such a move with the U.S. government.

Already, China and Russia have each approved vaccines without waiting for the completion of phase three trials, which come with the most rigorous testing for a potential new drug. Public health officials in the U.S. and elsewhere have warned that the move could be unsafe.

The coronavirus has infected more than 5.9 million people in the U.S. as of Saturday, representing about a quarter of the world’s reported cases, according to Johns Hopkins University data. The death toll in the U.S. has reached more than 182,000.