The Commissioner of the U.S. Food and Drug Administration, Dr. Stephen M. Hahn speaks during a press conference on the latest developments in coronavirus disease (COVID-19) in the Brady Press Briefing Room of the White House in Washington, USA, on August 23, 2020.
Erin Scott | Reuters
According to an interview in the Financial Times, the head of the US Food and Drug Administration is ready to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible.
FDA Commissioner Stephen Hahn insisted that the move was not due to pressure from the Trump administration to expedite a vaccine, telling the publication that emergency approval before completion of phase 3 clinical trials may be appropriate if the benefits outweigh the risks.
"It is up to the (vaccine developer) to apply for approval or approval and we decide on their application," Hahn told the Financial Times. "If they do that before the end of the third phase, we may find it appropriate. We may find it inappropriate, we will make a decision."
The comments come a week after the FDA granted emergency approval for convalescent plasma to treat Covid-19 patients in the hospital, although some health officials fear that data from clinical trials are too weak to support widespread use of the treatment. That announcement followed President Trump, who accused the FDA of trying, without evidence, to politically violate him by dragging his feet as he approved new coronavirus vaccines and treatments.
Hahn told the Financial Times that he wouldn't rush a vaccine just to please Trump.
"We have a convergence of the Covid-19 pandemic with the political season, and we just have to get through this and stick to our basic principles," said Hahn.
"This will be a science, medicine and data decision," he said. "This will not be a political decision."
He said emergency clearance could be used to safely make the vaccine available to specific groups before clinical trials are completed.
"Our emergency permit is not synonymous with a full permit," said Hahn. "The legal, medical and scientific standard for this is that the benefits outweigh the risks in a public health emergency."
Scott Gottlieb, former FDA chief, said on CBS "Face the Nation" Sunday that he was not sure what Hahn was talking about.
"I'm not sure what he means by approving it earlier than after the trials are over," said Gottlieb. "They will wait for these studies to be read before making a decision about the effectiveness of these vaccines."
He said it was likely that data from Phase 3 trials would be released in November. However, he said that as the studies progressed, if the results show the vaccine is very effective, it could be October.
Still, he expects the initial approvals to be issued in an emergency and aimed at groups that may be at higher risk of infection or poor outcome.
"Full approval for the general population – if people can go to CVS and get a chance – that really is a 2021 event," Gottlieb said.
Last week, the Financial Times reported that ahead of the presidential election, the Trump administration is considering emergency approval for an experimental coronavirus vaccine being developed in the UK by Oxford University and AstraZeneca.
At the time, a spokesman for the Department of Health and Human Services, which includes the FDA, said all reports of an emergency vaccine approval prior to the election were "dead wrong". AstraZeneca said it didn't discuss such a move with the U.S. government.
China and Russia have already approved vaccines without waiting for the completion of Phase 3 studies, which will run the toughest tests for a potential new drug. Public health officials in the US and elsewhere have warned the move could be unsafe.
The coronavirus infected more than 5.9 million people in the United States on Saturday, which is about a quarter of the cases reported worldwide, according to Johns Hopkins University. The death toll in the US has reached more than 182,000.