The White House blocked new Food and Drug Administration guidelines for the release of a coronavirus vaccine that would almost certainly have ensured the vaccine would not be approved before the presidential election on 3 November.
The FDA planned to instruct that vaccine developers follow patients in trials for at least two months, to rule out safety issues before seeking emergency approval.
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The proposed guidelines were submitted to the White House on 21 September, meaning the two-month period would extend beyond 3 November, when Donald Trump will seek re-election to the backdrop of a pandemic that has infected more than 7.5 million and killed more than 210,000 in the US.
Polling has consistently shown majority disapproval of Trump’s handling of the pandemic.
A senior administration official confirmed the move to block the guidelines to the Associated Press on Monday evening, saying the White House believed there was “no clinical or medical reason” for the additional requirement. The White House action was first reported by the New York Times.
It is the latest example of the administration undercutting its own experts working to combat Covid-19. The FDA commissioner, Stephen Hahn, has been attempting to shore up public confidence in the FDA vaccine review, vowing career scientists, not politicians, would decide if the shots are safe and effective for mass vaccination.
But Trump, himself a Covid-19 patient, has repeatedly insisted a vaccine could be authorised before election day, even though top government scientists have stated that that timeline is very unlikely.
In a Washington Post column last week, seven former commissioners blasted the administration for “undermining” the FDA and called for the release of the pending vaccine guidelines. The former FDA chiefs warned that perceptions a vaccine was rushed for political reasons could derail efforts to vaccinate millions of Americans.
Beyond the damaging optics of overruling its own FDA, the practical impact of the White House move to block the guidelines could be relatively small.
Only one drugmaker, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before election day. And a number of variables would still have to align for the company to submit, and the FDA to review and approve, a vaccine application before 3 November. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.
FDA scientists have been discussing the guidelines publicly for weeks and have made clear the recommendations have been shared with vaccine developers.
In an online interview last week with the non-profit Friends of Cancer Research, Dr Peter Marks, head of the FDA vaccine division, said releasing the guidelines was “an attempt to help the public see what we’re requiring”. He added that the guidelines would explain that all upcoming vaccines would be reviewed by FDA’s independent panel of vaccine advisers, before the agency makes its own final decision.
Marks said two months of safety follow-up for vaccines was important because the most serious side-effects connected with shots often occur several weeks after vaccination.
“The safety profile of a vaccine that’s going to be used in millions of people has to be incredibly clean,” Marks told the Journal of American Medical Association. Asked about the potential timing for a first vaccine, Marks said an emergency authorization could come “before the end of the year”.
FDA emergency authorization would probably limit initial use to medical and other frontline workers, nursing homes and people most at risk of catching or becoming seriously ill from the virus. The vaccine would have to undergo review for full FDA approval, a months-long process, before being approved for the general population
The FDA has faced criticism for allowing emergency use of some Covid-19 therapies backed by little evidence, but officials have made clear vaccines would face additional standards. Vaccines are given to healthy people and thus usually require more proof.
Trump made clear last month he was skeptical of any regulatory changes that might delay vaccine authorization, even if aimed at increasing public trust.
The senior administration official told the AP the White House was intent on getting a safe vaccine and wanted to make sure “additional loopholes” did not slow down the process. The FDA did not respond to requests for comment.
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