The White House has blocked new Food and Drug Administration (FDA) guidelines on bringing potential vaccines for COVID-19 to the market that would almost certainly have prevented their introduction before the Nov. 3 presidential election.
At issue was the FDA’s planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues before seeking emergency approval from the agency.
A senior administration official on Monday confirmed the move, saying that 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.
The intervention is the latest example of the White House undercutting its own medical experts working to combat the COVID-19 pandemic.
FDA Commissioner Stephen Hahn has been attempting to shore up public confidence in the agency’s vaccine review for weeks, vowing that career scientists, not politicians, would decide if the shots are safe and effective for mass vaccination, but US President Donald Trump has repeatedly said that a vaccine could be authorized before the election, even though top government scientists working on the administration’s vaccine effort have stated that that time line is very unlikely.
Seven former FDA commissioners last week criticized the administration for “undermining the credibility” of the FDA in a Washington Post op-ed and called for the release of the pending vaccine guidelines.
The former commissioners warned that public perceptions that a vaccine was rushed out for political reasons could derail efforts to vaccinate millions of Americans.
Beyond the damaging optics of overruling the FDA, the practical impact of the White House move to block the guidelines could be relatively small.
Only one company, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before the election 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 Nov. 3.
Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer researcher time lines.
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