President Donald Trump said on Wednesday that he might not approve new guidelines from the Food and Drug Administration meant to ensure high standards for coronavirus vaccines before they’re distributed to hundreds of millions of people.
The FDA’s proposed guidelines would reportedly require participants in late-stage trials to be tracked for a median of two months after receiving the final dose in order to make sure the vaccine has long-term efficacy, according to the Washington Post.
Additionally, the guidelines call for more thorough safety and manufacturing standards than those used to approve hydroxychloroquine and convalescent plasma—two potential treatments for the coronavirus that were promoted by Trump—in order to obtain an emergency authorization. (Hydroxychloroquine did not work.)
Introducing these stronger guidelines would make it even more unlikely that a vaccine would be approved by Election Day, which Trump has repeatedly touted as a rough estimate for approval time. And on Wednesday, Trump appeared to be ready to shut down the stronger regulations.
“We’re looking at that and that has to be approved by the White House. We may or may not approve it,” he said.
“I think that was a political move more than anything else,” Trump added. The FDA is inside of Trump’s own administration, and is run by a man he nominated, Dr. Stephen Hahn.
Trump’s politicization of the coronavirus vaccine has taken a toll on public confidence in the process. A recent Axios-Ipsos poll found that 60% of Americans don’t plan to get the vaccine as soon as it becomes available, with a plurality of respondents saying they’ll wait a few months and nearly a quarter saying they won’t get the vaccine at all. Earlier this month, nine pharmaceutical companies signed a pledge to develop vaccines based on “high ethics standards and sound scientific principles.”
During Senate testimony on Wednesday, Hahn maintained that the agency wouldn’t succumb to political pressure. “FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,” he said.
“Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes, and science will guide our decisions,” Hahn added. “FDA will not permit any pressure from anyone to change that.”
There are currently four large-scale Phase 3 vaccine trials ongoing in the United States, after a 60,000-participant single-shot Johnson & Johnson trial began this week. A U.S. trial by AstraZeneca remains on hold in the U.S. after a participant in the U.K. developed a serious spinal infection earlier this month.
More than 200,000 people in the United States have died as a result of the coronavirus so far this year, according to Johns Hopkins University. And after a brief reprieve from the peak of the coronavirus, cases have started to rise again in 22 states, seven of which—including Texas, Arizona, and Minnesota—have seen cases rise by more than 60%.
Cover: President Donald Trump speaks during a news conference in the James Brady Press Briefing Room of the White House Wednesday, Sept. 23, 2020, in Washington. (AP Photo/Evan Vucci)