FDA sets flu shot recommendations without input of outside advisers
The Food and Drug Administration on Thursday recommended to influenza vaccine manufacturers which virus strains to include in next season’s shots.
Typically, the agency sets its advice after consulting a committee of outside advisers, a meeting of whom had been scheduled to take place in March. But that meeting was abruptly canceled last month without explanation.
The cancellation raised some alarms as it followed the postponement of another vaccine panel meeting involved advisers to the Centers for Disease Control and Prevention. Public health experts are concerned Robert F. Kennedy Jr., in his new role as health secretary, may seek to disrupt or change existing processes for vetting vaccines.
The FDA made its strain recommendation after agency officials met with staff from the CDC and the Department of Defense. Similar to last year, they advised vaccine makers to prepare trivalent shots that target the H1N1, H3N1 and B/Victoria influenza lineages. They reached their decision after reviewing data on currently circulating strains as well as the efficacy of the shots now on market.
The regulator said it anticipates an “adequate and diverse supply of approved trivalent seasonal influenza vaccines for the 2025-2026 U.S. influenza season.”
While the recommendations of the FDA’s outside advisers usually follow international guidelines, lawmakers raised concerns last week that canceling the meeting reduced transparency in the process. Senators on the powerful health committee repeatedly quizzed Marty Makary, President Donald Trump’s nominee to run the FDA, on the issue. He denied any involvement in the decision to cancel, but said he would reevaluate which topics “deserve a convening of the advisory committee members” and which may not.
The committee on Thursday voted 14-9 to advance Makary’s nomination to the full Senate. If confirmed, Makary would report to Kennedy, who has spent years questioning the safety and efficacy of established vaccines.
In particular, Kennedy has claimed a link between vaccination and rising autism diagnoses, despite many studies not finding an association. The CDC is reportedly planning to study the issue, which is a top concern among the White House’s Make America Healthy Again Commission.
There is a growing outbreak of measles in Texas, where the first death from the disease since 2015 was recently reported. While Kennedy has written an op-ed recommending people discuss vaccination with their doctor, he also has promoted fringe theories and reiterated his view that vaccination is a “personal choice.”
This post has been syndicated from a third-party source. View the original article here.
