FDA Releases Flu Vaccine Guidelines Following Cancellation of Advisory Meeting
The FDA conducted a private session with its experts and officials from both the CDC and the Defense Department.
On Thursday, the U.S. Food and Drug Administration (FDA) provided guidelines to vaccine manufacturers concerning the virus strains to be included in the 2025–26 influenza vaccines. This announcement follows the cancellation of a meeting of its vaccine advisory committee that was originally planned for March 13.
Typically, the strain recommendations for flu vaccines are made with input from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). However, this year, the agency made the decision without consulting its advisers.
The agency advised the use of a trivalent formulation of egg-based influenza vaccines for the upcoming flu season, which will include two influenza A subtype viruses and one influenza type B virus.
The FDA noted that it has communicated its recommendations to vaccine manufacturers and expects “an adequate and diverse supply of approved trivalent seasonal influenza vaccines” for the upcoming influenza season, spanning the fall and winter months.
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The reason behind the cancellation of the VRBPAC meeting remains unclear, as the FDA has not provided an explanation.
The Infectious Diseases Society of America (IDSA)—which represents over 13,000 healthcare professionals and experts—has called on the FDA to reschedule the meeting, asserting that its cancellation could jeopardize public health amid the nation’s most severe flu season in over a decade.
In his address, Kennedy emphasized that his primary goal at HHS is “to reverse the chronic disease epidemic” in the U.S.
In addition to consulting its advisers, the FDA usually seeks guidance from the World Health Organization (WHO) on flu vaccine composition before issuing recommendations. However, the agency did not involve the WHO in its recent discussions about flu vaccines.
The president stated the WHO has failed to implement “urgently needed reforms” and has not demonstrated independence from “the inappropriate political influence” of its member states.
Zachary Stieber contributed to this report.
