FDA chief unsure of COVID vaccine recommendations, calling for more data
The approval and authorization of the COVID-19 vaccine for the upcoming winter season have been called into question by FDA Commissioner Dr. Marty Makary. In August 2024, the U.S. Food and Drug Administration approved an updated mRNA COVID vaccine to protect against current variants, as well as an updated Novavax vaccine. However, Makary has expressed doubts about the necessity of these vaccines for the 2025-2026 season.
Makary stated in an interview with CBS News that there is a lack of data surrounding the need for COVID boosters, citing a “public trust problem” as many healthcare workers opted out of receiving them last season. He emphasized the importance of good data to make informed decisions about the effectiveness of these vaccines.
The FDA chief also raised concerns about the lack of data supporting the Novavax COVID vaccine and called for additional studies to determine its effectiveness before approving it. He highlighted the need for a study on the new formulation and product to provide an evidence-based answer regarding its benefits.
Novavax recently posted an update on its website regarding the FDA’s request for an additional clinical trial. Makary emphasized the importance of knowing if vaccines work today in order to recommend them confidently.
The Centers for Disease Control and Prevention (CDC) has 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, including maintaining a universal vaccine policy, recommending them only for high-risk groups, or using risk-based recommendations up to age 64 and then switching to universal recommendations at age 65.
The main risk factors for severe COVID illness include advancing age, underlying medical conditions, and pregnancy, according to the CDC. Healthcare workers and those in long-term care facilities are at increased risk of exposure.
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Melissa Rudy is a senior health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.rudy@fox.com.
