COVID vaccine boosters called into question by FDA chief: ‘Void of data’

The FDA chief has called into question whether the agency will approve and authorize the COVID-19 vaccine for winter.

In August 2024, the U.S. Food and Drug Administration approved the updated mRNA COVID vaccine to protect against the current variants, and also approved an updated Novavax vaccine.

FDA Commissioner Dr. Marty Makary, however, has expressed doubts about whether that is necessary for the 2025-2026 season.

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"We're taking a look. I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots," Makary told CBS News on Tuesday, as the outlet reported.

"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," he added.

Makary also mentioned a "public trust problem" surrounding COVID boosters, noting that many healthcare workers opted out of receiving them last season.

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The FDA chief has also expressed concerns about the lack of data supporting Novavax’s COVID vaccine, calling for more studies into its effectiveness before approving it.

"The big Novavax 2020-2021 study excluded people with natural immunity to COVID. Today, there is broad population immunity, and the big question is, does it provide a benefit?" he said in an interview with Inside Medicine on Tuesday. 

"Without a study on the new formulation and product, we can’t give an honest, evidence-based answer to that question."

Novavax on Tuesday posted an update on its website of the FDA’s request for an additional clinical trial.

"It's my general feeling, not with this particular product, which I can't discuss in-depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them," Makary told CBS News on Tuesday.

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The Centers for Disease Control and Prevention (CDC) has also been considering narrowing the recommendations for widespread COVID vaccines starting in 2025-2026.

In an April report, the agency presented three options for COVID boosters: to maintain the "universal vaccine policy" for everyone aged 6 months and older, to only recommend them for groups at high risk of severe COVID illness, or to use risk-based recommendations up to 64 years of age and then switch to universal recommendations at age 65.

The main risk factors for severe disease include advancing age, underlying medical conditions and pregnancy, the CDC stated.

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