FDA Skeptical About Updating COVID-19 Boosters for Next Season

The U.S. Food and Drug Administration (FDA) is adopting a cautious stance regarding the approval of COVID-19 booster shots for the upcoming respiratory illness season. At the American Hospital Association's annual meeting, FDA Commissioner Dr. Marty Makary emphasized the importance of robust scientific data. He explained that vaccine manufacturers seeking approval are encouraged to conduct comprehensive clinical trials involving healthy participants, rather than relying solely on antibody responses or outdated data from previous years.

Makary highlighted that the current low confidence and uptake of COVID boosters among Americans—particularly noting that 85% of healthcare workers did not receive the most recent booster—are concerning factors in decision-making. He insisted that demonstrating clear clinical benefits through contemporary trials is essential, as boosting antibody levels does not necessarily translate into real-world protection.

The FDA is also reevaluating whether COVID vaccines should primarily target high-risk groups rather than the general healthy population. Makary questioned the rationale of administering multiple boosters to healthy, low-risk individuals, such as healthy children, stating, "Should we really be putting the full weight of the government to urge vaccination for a healthy, thin 12-year-old girl with her seventh COVID booster right now today in America?"

Additionally, Makary addressed recent staffing and operational concerns at the agency, asserting that despite some layoffs, the FDA has increased its workforce substantially since 2007—from 9,500 to approximately 19,000 employees—focused on public safety without compromising scientific integrity.

Overall, the FDA's approach suggests that the upcoming season may see delays or absence of updated COVID boosters unless new, convincing data can support their safety and efficacy, aligning vaccine approval with rigorous scientific standards.