By Dennis Thompson HealthDay Reporter<\/b>
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TUESDAY, May 6, 2025 (HealthDay News) — The head of the U.S. Food and Drug Administration (FDA) reiterated Tuesday that the agency is applying a more skeptical approach to this year\u2019s round of COVID-19<\/a> vaccine boosters.<\/p>\n Companies applying for approval of COVID boosters are being encouraged to use \u201cgold standard science,\u201d including full-fledged clinical trials involving healthy people, FDA Commissioner Dr. Marty Makary<\/a> said today at the American Hospital Association’s annual meeting in Washington, D.C.<\/p>\n That approach could mean no COVID boosters will be approved in time for next winter\u2019s respiratory disease season, Makary has warned in earlier interviews.<\/p>\n \u201cWe need some better data. We can’t just extrapolate from a clinical trial from four or five years ago,\u201d he said at the conference. \u201cAmericans have a very low uptake and a very low confidence of the COVID boosters right now.\u201d<\/p>\n For example, 85% of health care workers did not get the last COVID booster, Makary noted.<\/p>\n \u201cIt’s reasonable to say we’d like to see a clinical trial rather than just some antibodies that spike after you give [the vaccine],\u201d he said. \u201cYou can make antibodies spike to anything. That doesn’t tell us that it actually has a clinical benefit. Americans want to know, do we really, is there really a clinical benefit in healthy subjects?\u201d<\/p>\n The FDA also is considering whether COVID boosters should be given primarily to high-risk groups, as opposed to general coverage, Makary added.<\/p>\n \u201cShould 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?\u201d Makary said. \u201cI don’t think so.\u201d<\/p>\n The commissioner also downplayed the impact that layoffs ordered by the Trump Administration might have on the FDA\u2019s effectiveness.<\/p>\n \u201cThere’s a lot of people with impressive sounding titles, but that may not necessarily mean that they are working towards the core mission of the agency, which is to deliver more cures, diagnostics, therapeutics and healthy foods,\u201d Makary said. \u201cWe’re committed to public safety, which was why none of the cuts that were made included scientific reviewers or inspectors.\u201d<\/p>\n The FDA has doubled its staff since 2007, Makary said, increasing from 9,500 employees to 19,000 employees just a few months ago.<\/p>\n Under the Trump Administration, there\u2019s been a 12% reduction in the workforce, Makary said, noting that\u2019s a lower level of staffing cuts than those ordered under President Bill Clinton for the U.S. Department of Health and Human Services.<\/p>\n \u201cWe need a lean FDA that’s efficient, not a bloated FDA that is inefficient and slows down our approvals and inspections,\u201d Makary said.<\/p>\n More information<\/strong><\/p>\n The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccines<\/a>.<\/p>\n SOURCE: Presentation, American Hospital Association annual meeting, May 6, 2025<\/p>\n