The Food and Drug Administration announced its recommendations for the 2025-2026 influenza vaccine composition on Thursday, marking a departure from its usual process by proceeding without input from its external advisory committee.
The agency’s guidance to vaccine manufacturers came after internal discussions with officials from the Centers for Disease Control and Prevention and Department of Defense. The FDA advised companies to develop trivalent vaccines targeting three specific influenza strains: H1N1, H3N1, and B/Victoria lineages. These recommendations were based on analysis of current viral strains in circulation and the
effectiveness of existing vaccines.
The decision to bypass the traditional advisory committee meeting, which was unexpectedly canceled in February, has sparked concern among lawmakers and public health experts. This cancellation follows a similar postponement of a CDC vaccine advisory panel meeting, raising questions about potential changes to vaccine oversight under newly appointed Health Secretary Robert F. Kennedy Jr.
During recent Senate health committee hearings, FDA commissioner nominee Marty Makary faced questioning about the canceled meeting. While denying involvement in the cancellation decision, Makary indicated he would reassess which topics require advisory committee consultation. The committee subsequently voted 14-9 to advance his nomination to the full Senate.
The FDA maintains that it expects sufficient and varied trivalent seasonal influenza vaccine availability for the upcoming flu season. However, the agency’s deviation from standard procedure has attracted scrutiny, particularly given Kennedy’s history of questioning established vaccine practices.
Kennedy, who would oversee Makary if confirmed, has consistently challenged vaccine safety and efficacy, notably promoting disputed theories about connections between vaccines and autism rates. The CDC is reportedly planning to investigate this claimed association, despite numerous studies finding no such link. This investigation has become a priority for the White House’s Make America Healthy Again Commission.
The situation unfolds against the backdrop of a measles outbreak in Texas, where the first fatality since 2015 was recently documented. While Kennedy has publicly encouraged vaccine discussions between patients and their doctors, he continues to advocate for vaccination as a personal choice and has promoted controversial theories about immunization.
These developments reflect broader changes in vaccine policy oversight under the current administration. The FDA’s decision to proceed with flu shot recommendations without external expert consultation represents a significant shift from established protocols that typically involved public discussion and transparency in the decision-making process.
The agency’s recommendations emerged from their evaluation of circulating influenza strains and vaccine effectiveness data, maintaining the same target strains as the previous year. While the scientific basis for the selection remains consistent with past practices, the modified procedural approach has drawn attention from both healthcare professionals and political observers.
Legislators on the Senate health committee have expressed particular concern about the reduced transparency in the vaccine strain selection process. The cancellation of the advisory committee meeting, combined with similar disruptions to CDC vaccine panels, suggests potential changes in how vaccine-related decisions might be handled moving forward.
Despite these procedural changes, the FDA emphasizes its commitment to ensuring adequate vaccine supplies for the upcoming influenza season. The agency continues to coordinate with other federal health organizations, even as questions persist about the long-term implications of these modifications to established vaccine policy procedures.