The U.S. Food and Drug Administration announced its recommendations for the 2025-2026 influenza vaccine composition on Thursday, marking a departure from its usual process by bypassing consultation with external advisers.
The agency’s recommendations, which call for trivalent vaccines targeting H1N1, H3N1, and B/Victoria influenza strains, were formulated following discussions with the Centers for Disease Control and Prevention and Department of Defense officials. This decision came after the unexpected cancellation of a planned March advisory committee meeting.
The meeting’s cancellation has sparked concern among public health experts, particularly as it follows the postponement of a separate CDC vaccine advisory panel meeting. These developments have occurred in the context of Robert F. Kennedy Jr.’s appointment as health secretary, raising questions about potential changes to established vaccine evaluation procedures.
The FDA maintains that it expects sufficient and varied availability of approved trivalent seasonal influenza vaccines for the upcoming flu season. However, the bypassing of external advisers has drawn scrutiny from lawmakers, who questioned Marty Makary, President Trump’s FDA commissioner nominee, during recent Senate health committee hearings.
Makary, who denied involvement in the meeting’s cancellation, indicated he would reassess which topics require advisory committee input if confirmed. The committee subsequently voted 14-9 to advance his nomination to the full Senate, where, if confirmed, he would report to Kennedy.
Kennedy’s appointment has generated particular attention due to his history of questioning vaccine safety and efficacy. Despite numerous scientific studies finding no connection, he has persistently suggested links between vaccines and autism rates. Reports indicate the CDC is planning to investigate this claim, 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 has been reported. While Kennedy has publicly encouraged vaccine discussions between patients and their doctors, he continues to promote
alternative theories and emphasizes vaccination as a matter of personal choice.
The FDA’s strain selection process typically aligns with international guidelines and benefits from external expert input. The agency reached its recommendations after analyzing data on currently circulating influenza strains and evaluating the effectiveness of existing vaccines.
The decision to proceed without external advisers represents a significant shift in the typical vaccine recommendation process. This change occurs against a backdrop of evolving public health leadership and ongoing debates about vaccine policy and safety.
Lawmakers’ concerns about reduced transparency in the strain selection process were evident during Makary’s confirmation hearings. The nominee’s commitment to reevaluating advisory committee involvement suggests potential changes in how the FDA approaches such decisions in the future.
The confluence of these developments – the canceled advisory meeting, Kennedy’s appointment as health secretary, the Texas measles outbreak, and the pending confirmation of a new FDA commissioner – highlights the complex intersection of public health policy, scientific expertise, and political leadership in vaccine decision-making.
The FDA’s ability to maintain its traditional science-based approach to vaccine recommendations while adapting to new administrative priorities remains under close observation by healthcare
professionals, lawmakers, and the public health community.