The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget.
President Donald Trump said Wednesday that the White House may not approve tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines.
“That has to be approved by the White House,” Trump said. “We may or may not approve it.”
Trump also suggested that the FDA’s decision to revise the standards, first issued in June, “was a political move more than anything else.” The president has repeatedly vowed that a vaccine would be available by Election Day, although prominent scientists within his administration have said it’s extremely unlikely.
The stricter FDA standards cleared a review by the Department of Health and Human Services on Tuesday, with the expectation that the White House would soon approve them, according to two people with knowledge of the timeline.
Trump’s remarks came hours after he spoke with HHS Secretary Alex Azar about the FDA proposal, two people familiar with the situation said. The president’s criticism throws into jeopardy an effort viewed as key to boosting public confidence in any eventual coronavirus vaccine.
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