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Makary: FDA Won’t Approve COVID Boosters Without ‘Some Good Data’

FDA Commissioner Marty Makary on Tuesday said the agency is still considering whether or not to approve COVID-19 vaccines for this winter, citing a lack of data. Makary’s approach marks a change from how the FDA previously approved COVID-19 boosters each year, CBS News reported.

In an interview this week with the editor-in-chief of MedPage Today, Dr. Marty Makary said, “Look, 85% of healthcare workers declined the latest Covid booster vaccine last fall. Should we accept that and just keep pounding on parents to get their healthy 12-year-old daughter a 7th Covid jab this fall? Or should we make evidence-based recommendations based on a meaningful study showing a clinical benefit today?”

The FDA has received “a bunch of applications” from COVID-19 vaccine manufacturers for their 2025 booster products, Makary, who formerly served as editor-in-chief of MedPage Today, told CBS News. He said:

“We’re taking a look. I can’t comment on any particular application. … I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

The FDA has now asked several COVID-19 vaccine makers, including Novavax, to do clinical studies “so we can educate the population and have information to work with,” Makary told CBS News.

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