President Donald Trump said Wednesday that he may reject new Food and Drug Administration guidelines that toughen the rules around the emergency approval of a coronavirus vaccine, undercutting the nation’s top scientists who have sought to allay any fears about a rushed approval.
“That has to be approved by the White House,” Trump said at a briefing on the potential new guidelines. “We may or may not approve it.”
The FDA said earlier this week that it planned to soon release stricter guidelines for vaccine approval, which would lay out specific rules for clinical trial data and recommend any results be vetted by independent experts. The comments also came just hours after four of the country’s top doctors — including FDA Commissioner Stephen Hahn and Dr. Anthony Fauci, the nation’s top infectious disease expert — defended the agency’s work and said it was relying on science, not political pressure from the White House.
Trump, however, used the briefing Wednesday to say that the stricter guidelines meant to bolster faith in any vaccine sounded “like a political move” and that he had “tremendous trust” in the pharmaceutical giants working to develop them, adding that he wasn’t sure “a government as big as” the U.S. could do as good of a job.
“When you have great companies coming up with these vaccines, why would [the FDA] have to be, you know, adding great length to the process?” Trump said. “We want to have people not get sick. I don’t see why it should be delayed further.”
The move comes as four vaccine candidates are in their final, large-scale clinical trials in the U.S. But the companies developing them do not yet know conclusively if they will work as hoped, despite Trump’s insistence that the country could see a useable vaccine approved before the end of the year.
But public support for the vaccine has fallen in recent weeks, and a Pew Research poll released earlier this month found just 51% of Americans said they would get a vaccine once one is released. That was a 21 percentage point drop from a similar poll in May.
I will fight for the integrity of the agency, and I will put the interests of the American people before anything else. Stephen Hahn, commissioner of the Food and Drug Administration
The U.S. passed a grim milestone in the pandemic this week after official figures showed more than 200,000 people in the country have now died of COVID-19.
Hahn told senators on Wednesday that the agency would “not authorize or approve a vaccine we won’t be confident in giving to our families.”
“I will fight for science,” Hahn told a Senate committee. “I will fight for the integrity of the agency, and I will put the interests of the American people before anything else.”
Hahn, Fauci, Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention, and Adm. Brett Giroir, the coronavirus testing czar, all said they would take any vaccine approved by the FDA as well, in a show of support for the agency’s work.
“What I can tell you is, we do feel the urgency of the moment,” Hahn told lawmakers Wednesday. “We will not delay, but we will not cut corners.”
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