WASHINGTON – The White House embraced guidelines published Tuesday by the Food and Drug Administration that would likely slow approval of a coronavirus vaccine by requiring drug makers to conduct trials for two months before requesting approval.
President Donald Trump had previously balked at the guidance, telling reporters last month that the FDA proposal had to be approved by the White House and arguing that he thought they might have been “a political move more than anything else.”
The FDA published the guidelines Tuesday, a day after Trump returned to the White House after being treated for the virus at Walter Reed National Military Medical Center and told Americans in a video they should not fear COVID-19 and that a vaccine is coming “momentarily.” Trump has expressed optimism about the vaccine but public health officials have urged caution.
“We may or may not approve it. That sounds like a political move,” Trump said on Sept. 23. “Because when you have Pfizer, Johnson and Johnson, Moderna, these great companies coming up with the vaccines and they’ve done testing and everything else. I’m saying, why would they have to be adding great length to the process. We want to have people not get sick.”
A senior administration official speaking on the condition of anonymity to discuss internal deliberations confirmed to USA TODAY that the White House backed the plan.
In documents posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval. That requirement would likely preclude the introduction of a vaccine before the Nov. 3 presidential election.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Trump, who is facing a challenging path to reelection this year in part because of the pandemic, has frequently hinted at the possibility that a vaccine could potentially be approved before the election and widely available early next year.
A senior administration told the Associated Press this week that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the 2-month data requirement, arguing there was “no clinical or medical reason” for it. Other officials within the White House disputed that characterization, arguing that the guidance was working its way through the normal review process.
Contributing: Associated Press