The U.S. Food and Drug Administration is implementing a more stringent approach to COVID-19 vaccine booster approvals that could result in no updated shots being available for the upcoming winter respiratory season, FDA Commissioner Dr. Marty Makary announced Tuesday.
Speaking at the American Hospital Association's annual meeting in Washington, D.C., Makary emphasized that pharmaceutical companies seeking booster approvals must now provide robust clinical trial data rather than relying solely on antibody response measurements.
"We need some better data. We can't just extrapolate from a clinical trial from four or five years ago," Makary stated. "Americans have a very low uptake and a very low confidence of the COVID boosters right now."
Demand for Stronger Evidence
The FDA's new approach represents a significant shift in how COVID-19 boosters are evaluated. Previously, updated boosters could gain approval based primarily on laboratory data showing increased antibody production. Now, manufacturers must conduct "gold standard science" including comprehensive clinical trials with healthy participants.
"It's reasonable to say we'd like to see a clinical trial rather than just some antibodies that spike after you give [the vaccine]," Makary explained. "You can make antibodies spike to anything. That doesn't tell us that it actually has a clinical benefit. Americans want to know do we really, is there really a clinical benefit in healthy subjects."
This heightened scrutiny comes amid declining public interest in COVID-19 boosters. Makary highlighted that 85% of healthcare workers—typically among the most vaccine-conscious groups—did not receive the most recent COVID-19 booster, suggesting widespread skepticism about the necessity of continued boosting.
Targeted Approach to High-Risk Groups
The FDA is also reconsidering whether COVID-19 boosters should be universally recommended or primarily targeted at high-risk populations. This represents another potential shift in public health strategy.
"Should we really be putting the full weight of the government to urge vaccination against COVID for a healthy, thin 12-year-old girl with her seventh COVID booster right now today in America?" Makary questioned. "I don't think so."
This targeted approach would align COVID-19 vaccination strategy more closely with other respiratory virus vaccines, such as seasonal influenza shots, which are particularly emphasized for vulnerable populations.
FDA Staffing and Efficiency
During his presentation, Makary also addressed concerns about recent staffing reductions at the FDA under the Trump Administration. He downplayed the impact of these cuts, noting that they did not affect scientific reviewers or inspectors critical to the agency's core functions.
"There's a lot of people with impressive sounding titles, but that may not necessarily mean that they are working towards the core mission of the agency, which is to deliver more cures, diagnostics, therapeutics and healthy foods," Makary said.
The commissioner noted that despite a recent 12% workforce reduction, the FDA had previously doubled its staff from 9,500 to 19,000 employees since 2007. He characterized the current cuts as part of an effort to create "a lean FDA that's efficient, not a bloated FDA that is inefficient and slows down our approvals and inspections."
Implications for Respiratory Disease Season
The FDA's more cautious approach to COVID-19 boosters raises questions about preparedness for the upcoming respiratory disease season. Without updated boosters, public health officials may need to rely more heavily on existing vaccines and other preventive measures.
Some experts worry that the absence of updated boosters could leave vulnerable populations at greater risk, particularly if new variants emerge. However, others support the FDA's move toward requiring stronger evidence of clinical benefit before recommending additional shots.
The decision reflects broader questions about the long-term strategy for managing COVID-19 as it transitions from a pandemic emergency to an endemic respiratory disease that requires sustainable, evidence-based approaches to prevention and control.
For now, individuals at high risk for severe COVID-19 complications should consult with their healthcare providers about vaccination recommendations based on their specific health conditions and circumstances.
