The US Food and Drug Administration (FDA) told coronavirus vaccine developers on Tuesday it wants at least two months of safety data before authorizing any emergency use, a requirement likely to push any US vaccine availability past the 3 November presidential election.
A senior administration official confirmed that the White House had approved the plan, which undercuts Donald Trump’s hopes of getting a vaccine before the majority of voters go to polls.
The president had been hinting at a rapid announcement on a successful vaccine in recent weeks despite the fact that a candidate has yet to emerge from clinical trials and there have been growing fears that political pressure on regulators could result in a compromised process and the undermining of public confidence in a vaccine.
The FDA on Tuesday released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.
The White House had earlier blocked new FDA guidelines that jeopardized the chances of a vaccine being approved before the election. It appeared on Tuesday afternoon that it had backed down.
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 had 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.
Trump criticized the FDA rules in a late night tweet on Tuesday, calling it a “political hit job”.
Itwas 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, now himself a Covid-19 patient, has repeatedly insisted a vaccine could be authorized 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.