The U.S. Food and Drug Administration announced its recommendations for the 2025-2026 influenza vaccine composition on Thursday, marking a departure from its typical process by proceeding without consulting its external advisory committee.
The agency made its determinations after coordinating with officials from the Centers for Disease Control and Prevention and Department of Defense, recommending that manufacturers develop trivalent vaccines targeting the H1N1, H3N1, and B/Victoria influenza strains. These recommendations were based on analysis of currently circulating virus strains and the effectiveness of existing vaccines.
The decision follows the unexpected cancellation of a planned March advisory committee meeting, which has raised concerns among public health experts, particularly in light of newly appointed Health Secretary Robert F. Kennedy Jr.’s historical skepticism toward vaccines. The cancellation also came after a separate CDC vaccine advisory panel meeting was postponed.
During recent Senate hearings, Marty Makary, President Trump’s nominee to lead the FDA, faced questioning about the canceled meeting. While denying involvement in the cancellation decision, Makary indicated he would review which topics require advisory committee consideration if confirmed. The Senate health committee subsequently voted 14-9 to advance his nomination.
The FDA expressed confidence that there will be sufficient and varied trivalent seasonal influenza vaccine supply for the upcoming flu season. However, lawmakers have expressed unease about the reduced transparency in the decision-making process following the advisory meeting’s cancellation.
The developments occur against a backdrop of growing public health challenges, including a measles outbreak in Texas that has resulted in the first death from the disease since 2015. While Kennedy has encouraged people to discuss vaccination with their healthcare providers, he has maintained his stance that vaccination should remain a personal choice and has continued to promote controversial theories about vaccine safety.
Of particular concern is Kennedy’s long-standing assertion of a connection between vaccines and autism rates, despite numerous scientific studies finding no such link. 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 FDA’s decision to proceed with vaccine strain recommendations without external adviser input represents a significant shift in the traditional process. Typically, these recommendations are made after consulting with outside experts and align with international guidelines. The change has drawn attention from lawmakers and public health officials concerned about maintaining transparency and scientific rigor in vaccine-related decisions.
If confirmed, Makary would report directly to Kennedy, whose appointment as health secretary has raised questions about potential changes to established vaccine policy and oversight procedures. Kennedy’s history of challenging mainstream vaccine science and his promotion of alternative theories about vaccine safety have created uncertainty about the future direction of national vaccination programs.
The FDA’s streamlined approach to this year’s flu vaccine composition recommendations signals a potential shift in how vaccine-related decisions may be handled under the current administration. While the agency maintains its commitment to ensuring adequate vaccine supply, the modified process has sparked debate about the balance between efficient decision-making and maintaining transparent, science-based protocols in public health policy.