As the 2025–2026 COVID-19 booster season approaches, FDA Commissioner Dr. Marty Makary is urging a full reassessment, citing a disturbing lack of data behind the latest approvals.
At a Glance
- FDA Commissioner Marty Makary questions the 2025–2026 boosters due to limited supporting data
- CDC is weighing changes to focus boosters on high-risk populations
- Novavax’s earlier trials excluded people with natural immunity, prompting concern
- Public health officials remain split over balancing data and policy
FDA Chief Demands Data Before More Boosters
Dr. Marty Makary, recently named FDA Commissioner, has openly challenged the current booster rollout, arguing that new shots have been approved without adequate supporting evidence. In an interview with Fox News, Makary said, “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 pointed specifically to the updated mRNA and Novavax vaccines approved in August 2024, stating that long-term efficacy data is lacking and that broader studies are needed. As he told CBS News, “Without a study on the new formulation and product, we can’t give an honest, evidence-based answer to that question.”
Watch CBS News’ report on the incident at FDA Commissioner Makary’s stance on COVID-19 boosters.
CDC Mulls Overhaul of Recommendations
Meanwhile, the Centers for Disease Control and Prevention is quietly considering major changes to its booster policies. According to Reuters, the agency is reviewing whether to maintain a universal booster strategy or limit shots to older adults and people with underlying conditions. The shift comes as new data shows severe COVID-19 outcomes are now mostly confined to high-risk groups.
A recent bulletin from the CDC’s Morbidity and Mortality Weekly Report recommends that adults aged 65 and older receive two doses of the 2024–2025 vaccine. Individuals younger than 65 but with moderate or severe immunocompromise may also receive boosters at their healthcare provider’s discretion.
Questions Over Natural Immunity in Novavax Studies
Concerns are especially pointed toward Novavax, whose 2020–2021 trial notably excluded individuals with natural immunity. As documented in The Lancet Microbe, its trial protocol deliberately enrolled participants without prior SARS-CoV-2 infection. This omission is now being challenged by experts who say today’s immunity landscape is drastically different.
Makary emphasized that with widespread population exposure, studies must now account for people who’ve already had COVID. Without that inclusion, he argues, any efficacy claims are inherently flawed.
FDA officials have reportedly asked Novavax to submit additional data that accounts for prior infection. Until then, its role in this fall’s booster campaign may remain in flux.
Walensky’s Past Decision Still Reverberates
A key moment that reflects the tension between science and policy came in 2021, when then-CDC Director Rochelle Walensky overruled her own advisory panel. Despite their recommendation against expanding Pfizer-BioNTech boosters to all at-risk workers, Walensky went forward, citing frontline risks for healthcare and education sectors. As reported by The New York Times, the decision triggered both praise and alarm over scientific independence.
Now, with Makary calling for more trials and data-based decisions, the divide between public health policy and clinical evidence appears to be widening again. The debate over COVID boosters remains a flashpoint in U.S. health leadership, with data, trust, and public safety hanging in the balance.
