The Food and Drug Administration announced its recommendations for the 2025-2026 influenza vaccine composition on Thursday, marking a departure from its typical process by bypassing input from its external advisory committee.
The agency made its strain selection recommendations after consulting with officials from the Centers for Disease Control and Prevention and Department of Defense, rather than holding its customary meeting with outside advisers. The previously scheduled March advisory committee meeting was unexpectedly canceled last month without explanation.
The timing of the cancellation has sparked concerns among public health experts, particularly as it followed the postponement of a separate CDC vaccine advisory panel meeting. Some worry these changes may reflect attempts by newly appointed Health Secretary Robert F. Kennedy Jr. to alter established vaccine review procedures.
In its announcement, the FDA recommended that manufacturers develop 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 variety and quantity of approved trivalent seasonal flu vaccines for the upcoming U.S. flu season.
The cancellation of the advisory committee meeting has drawn scrutiny from lawmakers, who questioned FDA commissioner nominee Marty Makary about the decision during recent Senate health committee hearings. While Makary denied involvement in the meeting’s cancellation, he indicated he would review which topics warrant advisory committee consultation if confirmed. The committee subsequently voted 14-9 to advance his nomination to the full Senate.
If confirmed, Makary would report to Kennedy, whose appointment as health secretary has generated controversy due to his long history of questioning vaccine safety and efficacy. Kennedy has notably promoted disputed theories about vaccines and autism, despite numerous studies finding no connection. Reports indicate the CDC is planning to investigate this issue under the White House’s Make America Healthy Again Commission’s direction.
The developments come amid a concerning measles outbreak in Texas, where the first death from the disease since 2015 was recently documented. While Kennedy authored an op-ed encouraging people to discuss vaccination with their healthcare providers, he has continued to promote controversial theories and emphasize vaccination as a matter of personal choice.
The FDA’s deviation from standard procedure in making its flu vaccine recommendations highlights growing tensions between established public health protocols and new political appointments. The agency’s decision-making process typically involves transparent consultation with external experts, following international guidelines for vaccine composition.
The changes in vaccine advisory procedures occur as the pharmaceutical industry continues to adapt and respond to evolving public health needs. Major vaccine manufacturers are preparing to implement the FDA’s recommendations for the upcoming flu season, even as questions persist about the modified approval process.
The agency maintains that its recommendations are grounded in scientific data and analysis, despite the altered consultation process. However, the departure from traditional advisory committee involvement has raised questions about transparency and the potential influence of political appointments on public health decision-making.
This situation reflects broader changes in how vaccine-related decisions are being handled under the current administration, with implications for both public health policy and vaccine confidence among the American public. The confluence of these developments has created uncertainty about the future of vaccine policy oversight and implementation in the United States.