The head of the U.S. Food and Drug Administration on Tuesday reportedly raised doubts about the need for COVID booster shots for all Americans and questioned the success of past clinical trials, after earlier suggesting the shots might not be approved for next winter.
“We need some better data,” FDA Commissioner Dr. Marty Makary said at the American Hospital Association’s annual meeting in Washington, D.C., according to news outlet HealthDay.
Makary, who last week told CBS News that the shots may not be approved for later this year due to a “void” of supporting data, said pharmaceutical companies are being urged to use “gold standard science” to show that the shots have a clinical benefit.
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“We can’t just extrapolate from a clinical trial from four or five years ago,” he said Tuesday. “Americans have a very low uptake and a very low confidence of the COVID boosters right now.”
He also said that the FDA is considering whether to recommend the shots to everyone or primarily to high-risk groups.
“Should we really be putting the full weight of the government to urge vaccination against COVID for a healthy, thin 12-year-old girl with her seventh COVID booster right now today in America?” he said. “I don’t think so.”
Makary, who was confirmed to lead the FDA in March, is a former Johns Hopkins University surgeon and researcher who during the pandemic publicly opposed vaccine mandates and criticized the department that he now leads.
He in particular spoke out against requiring booster shots in young people, with him concluding in a 2022 paper he co-authored that the shots “are expected to cause a net harm.” That paper was criticized as being unobjective and based on cherry-picked information that excluded opposing data.
The FDA on Wednesday said it will hold a public discussion later this month with independent outside experts to discuss and make recommendations on the selection of the COVID-19 vaccine’s 2025-2026 formula.
“The general function of the committee is to provide advice and recommendations to FDA on regulatory issues,” the FDA said in a draft notice of the May 22 meeting that was posted online.