The Food and Drug Administration (FDA) announced its recommendations for next season’s influenza vaccine composition on Thursday, marking a departure from its usual process by bypassing input from external advisers.
The agency’s guidance to vaccine manufacturers came after internal discussions with officials from the Centers for Disease Control and Prevention (CDC) and Department of Defense, rather than through the traditional consultation with an advisory committee. The previously scheduled March meeting with outside experts was unexpectedly canceled last month.
The timing of the cancellation has sparked concern among public health experts, particularly as it follows the postponement of another vaccine-related meeting involving CDC advisers. These developments have raised questions about whether newly appointed Health Secretary Robert F. Kennedy Jr. might seek to alter established vaccine review procedures.
Following their internal deliberations, FDA officials recommended that manufacturers prepare trivalent vaccines targeting the H1N1, H3N1, and B/Victoria influenza lineages, maintaining consistency with the previous year’s guidance. This decision was based on analysis of currently circulating virus strains and the effectiveness of existing vaccines. The agency expressed confidence that there would be sufficient and varied trivalent seasonal influenza vaccine supply for the 2025-2026 U.S. season.
The canceled advisory committee meeting became a focal point during recent Senate hearings for FDA commissioner nominee Marty Makary. When questioned by lawmakers on the Senate health committee about the meeting’s cancellation, Makary denied involvement in the decision but indicated he would review which topics warrant advisory committee consideration. The committee subsequently voted 14-9 to advance his nomination to the full Senate.
If confirmed, Makary would report to Kennedy, who has historically questioned vaccine safety and efficacy. Kennedy has notably promoted controversial theories about vaccines, including suggesting links between vaccination and autism rates, despite numerous studies finding no such connection. The CDC is reportedly planning to investigate this concern, which has become a priority for the White House’s Make America Healthy Again Commission.
The situation has taken on added significance amid a measles outbreak in Texas, where the first death from the disease since 2015 was recently documented. While Kennedy has publicly encouraged people to discuss vaccination with their healthcare providers, he continues to promote alternative theories and emphasizes vaccination as a “personal choice.”
The decision to bypass the advisory committee has drawn criticism from lawmakers, who argue it reduces transparency in the vaccine
recommendation process. This comes at a time when public health officials are working to maintain confidence in vaccination programs while navigating political pressures and public skepticism.
The FDA’s ability to make these recommendations without external advisory input demonstrates the agency’s established internal expertise in evaluating influenza strain data. However, the departure from traditional procedures has highlighted ongoing tensions between maintaining efficient public health processes and ensuring transparent decision-making in vaccine policy.
Despite these challenges, the FDA maintains that its recommended vaccine composition for the upcoming flu season is based on
comprehensive scientific analysis and coordination with other federal health agencies. The focus now turns to manufacturers’ implementation of these recommendations and the broader implications for vaccine policy under the current administration.