JUST IN: Trump White House Reportedly Blocks FDA’s More Rigorous Safety Guidelines That Could Extend Covid Vaccine Release Past Election Day
Photo credit: Sarah Silbiger, Getty Images.
The Trump White House is blocking more rigorous new safety guidelines from the FDA about the potential Covid-19 vaccines, which would, coincidentally, push the release of any coronavirus inoculation well past Election Day. President Donald Trump has repeatedly predicted that his Operation Warp Speed will produce a vaccine well before the end of the year, and clearly alluded to Election Day as his target date.
According to the New York Times, White House chief of staff Mark Meadows raised objections to the guidelines, which the FDA submitted to the Office of Management and Budget two weeks ago.
In late September, the FDA signaled that it would extend by two months its follow-up safety tracking period for the Phase 3 trials of the four various Covid-19 vaccine candidates. This new timeline, notably, would make it virtually impossible to approve any possible coronavirus vaccine by late October or early November, in time for Election Day. Days later, HHS Secretary Alex Azar appeared to back the FDA’s move — and contradict Trump — when he assured Fox News’ Bret Baier that his agency would follow the science and not succumb to White House pressure to speed the vaccine through for political reasons.
But the Times reports that the FDA is trying an end-around the White House, pushing for an outside scientific review before any vaccine candidate is approved for emergency use authorization.
Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards with an outside advisory committee of experts — perhaps as soon as this week — that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.
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Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. [Stephen] Hahn was overly influenced by his agency’s career scientists.
The White House refused to comment for the Times story.
The prospect of a coronavirus vaccine has become a political football in the 2020 race. Trump has repeatedly dangled the promise of a vaccine before the election as a kind of campaign prop, while Democratic challenger Joe Biden has openly questioned the efficacy and safety of any vaccine that appears rushed to market for political reasons.
