FDA willing to fast track vaccine before trial ends,

Authorization could come before rigorous phase of trials ends.

Food and Drug Administration Commissioner Stephen Hahn, who has been under pressure from

the White House to speed coronavirus treatments, said in a news

paper interview that his agency would be willing to approve a virus vaccine before Phase 3 clinical trials were complete if the agency found it “appropriate” to do so.

Hahn told the Financial Times that a vaccine developer could apply for approval before the end of Phase 3 clinical trials, which are the largest and most rigorous, but that the agency would make “a science, medicine, data decision” and might issue emergency authorization for use for particularly vulnerable groups rather than a blanket approval. “This is not going to be a political decision,” he said.

Hahn’s comments came at the end of a particularly turbulent week for the FDA. Last weekend,

after President Donald Trump criticized the agency for moving too slowly to develop vaccines and treatments and accused it of being part of the “deep state,” Hahn appeared with Trump at a news conference where they made erroneous claims that overstated the benefits of plasma treatments for COVID-19, prompting a wave of scientific criticism. Hahn later corrected the misleading claims. On Thursday, the Department of Health and Human Services, parent agency of the FDA, terminated the contract of a public relations consultant who had advised Hahn to issue the correction, and the FDA’s chief spokeswoman, who had been on the job for just 11 days, was removed from her position.

Last week, the New York Times reported that on July 30, Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows told House Speaker Nancy Pelosi and Sen. Chuck Schumer, the Democratic leader, that a vaccine would probably be given U.S. emergency approval before the end of Phase 3 clinical trials, perhaps as early as late

September.

The account was based on information from two people briefed on the discussion, who said Meadows indicated the approved vaccine would likely be the one being developed by AstraZeneca and Oxford University, which is now undergoing Phase 2 and Phase 3 trials in Britain, Brazil and South Africa. However, senior administration officials disputed the account.

Last week, Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, told The Times

of London that three vaccine candidates focused on by Operation Warp Speed, the White House’s effort to speed vaccine development, were lined up for testing and that getting results by November or December was “a safe bet.” He also said “it is conceivable

that we would get an answer before that.”

An independent advisory committee is scheduled to meet Oct. 22 to discuss vaccines in development, but Hahn has said the agency was prepared to “rapidly” schedule additional meetings once a vaccine application is submitted.

China and Russia have both approved vaccines without wait

ing for the end of Phase 3 trials, drawing criticism from global health experts.