The Trump administration is weighing a fast-tracked process that would allow AstraZeneca’s coronavirus vaccine to be used in the US before November’s presidential election, a new report says.
One plan under consideration would see the Food and Drug Administration issue an “emergency use authorization” for the British drugmaker’s vaccine candidate in October, the Financial Times reported Sunday, citing three people briefed on the plan.
The authorization, known as an EUA, would be based on forthcoming results from a study involving 10,000 people in the UK — even though federal agencies have said a study of 30,000 people would be needed to win such an approval, according to the paper.
White House Chief of Staff Mark Meadows and Treasury Secretary Steven Mnuchin reportedly discussed plans to fast-track a vaccine in a July 30 meeting with House Speaker Nancy Pelosi and Democratic Sen. Chuck Schumer.
Meadows said then that officials could grant an EUA in September, possibly for AstraZeneca’s vaccine, while Mnuchin said officials expected an emergency authorization to come before full approval of a shot, the Financial Times reported.
But a spokesman for the Department of Health and Human Services, which includes the FDA, told the paper that claims about an EUA coming before the election were “absolutely false.” The Trump administration hasn’t changed its goal of having a vaccine developed by the first quarter of next year, he said.
“Talk of an October surprise is a lurid resistance fantasy,” the spokesman, Michael Caputo, told the FT. “Irresponsible talk of an unsafe or ineffective vaccine being approved for public use is designed to undermine the president’s coronavirus response.”
AstraZeneca spokesman Matthew Kent said the company “has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility.”
Approving a vaccine so early could help Trump tout his response to the coronavirus pandemic, which has faced criticism as the virus infected more than 5 million Americans and killed more than 176,000.
But it could also face resistance — Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told Reuters last week that he would resign if a vaccine was approved before being proven safe and effective. Pelosi has also warned Trump not to politicize the FDA.
AstraZeneca’s vaccine, developed with the University of Oxford, is one of six candidates the Trump administration is supporting through Operation Warp Speed — its initiative to deliver a safe and effective COVID-19 inoculation by early next year.
The UK-based company has started a Phase 3 trial of the vaccine in Brazil and expects to have results from late-stage studies later this year.
AstraZeneca shares were up 3.4 percent in premarket trading Monday at $57.60 as of 7:47 a.m.
Credit: Source link