Dr Hahn told the journal that a vaccine developer could seek approval before the Phase 3 clinical trials, which are the most important and rigorous, are completed, but that the agency will make “a scientific, medical decision. , data ”and could urgently issue an authorization for use for particularly vulnerable groups rather than a blanket approval.
“It will not be a political decision,” he said.
Dr Hahn’s comments, published online Sunday by the Financial Times, were not his first indication that the agency could speed up a vaccine under the right circumstances, which would not be at odds with the agency’s standard protocols. . But the interview comes at the end of a particularly hectic week for the FDA
Last weekend, after President Trump criticized the agency for moving too slowly to develop vaccines and treatments and accused it of being part of the “deep state”, Dr Hahn appeared with Mr Trump at a press conference where they made exaggerated misrepresentation. the benefits of plasma treatments for Covid-19, sparking a wave of disbelief and scientific criticism.
Dr Hahn later corrected the misleading claims. On Thursday, the Department of Health and Human Services, the FDA’s parent agency, terminated the contract of a public relations consultant who advised Dr Hahn to issue the correction, and the spokesperson in FDA chief, who had been on the job for just 11 days, was removed from his post.
Last week, The Times reported that on July 30, Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows told President Nancy Pelosi and Senator Chuck Schumer, the Democratic leader, that a vaccine would likely be approved urgently before the end of Phase 3 clinical trials in the United States, possibly as early as late September.
The account was based on information from two people familiar with the discussion, who said Mr Meadows had indicated that it was likely to be the one developed by AstraZeneca and the University of Oxford, which is currently undergoing Phase 2 trials and phase 3 in Great Britain, Brazil. and South Africa. However, senior administration officials disputed the account, claiming that Mr Meadows and Mr Mnuchin were either misrepresented or misunderstood.
Last week, Dr Anthony S. Fauci, the country’s foremost infectious disease expert, told The Times of London that three vaccine candidates at the heart of Operation Warp Speed, the White House’s effort to speed up vaccine development, were lined up for testing and that getting results by November or December was “a safe bet.” He also said it was “conceivable that we would get a response before that”.