FDA approves first mRNA flu jab for older adults as CDC guidance stalls

The approval of mFlusiva has exposed a fractured US vaccine advisory system, leaving doctors, insurers and patients to navigate without clear federal guidance.

The federal government’s vaccine policy machinery is showing signs of strain after the Food and Drug Administration approved mFlusiva, the first mRNA flu shot authorised in the United States for adults aged 50 and over, yet the Centres for Disease Control and Prevention has still not issued a public recommendation for its use. The CDC has instead said it is sticking with last year’s flu guidance because of legal uncertainty, leaving the new vaccine outside the list of shots it is officially endorsing for the current season. That gap is striking because, under the old system, FDA approval was typically followed by a CDC recommendation that helped determine how quickly doctors and insurers would embrace a new vaccine.

The hold-up reflects a broader breakdown in the vaccine advisory process that has accelerated over the past year. For decades, the CDC relied on its Advisory Committee on Immunisation Practices, which met in public, reviewed evidence and voted on recommendations that usually became the agency’s official guidance. That system was disrupted after Health Secretary Robert F. Kennedy Jr. dismissed the panel and replaced it with a new group that included several vaccine sceptics. In March, a federal judge said Kennedy probably broke federal procedures, blocked the new panel from meeting further and suspended his move to reduce the number of childhood vaccines recommended by the government. According to AP News, the result has been a stalled, splintered process in which new vaccines and revised guidance are left in limbo.

In the absence of clear federal direction, medical associations have begun charting their own course. Working with a University of Minnesota researcher, several specialty groups have reviewed vaccine evidence privately and issued recommendations of their own, a role they once shared with the CDC panel. Private insurers, through their industry trade association, have said they will follow those medical-society recommendations, and many of the updates match earlier CDC guidance. One example is the respiratory syncytial virus, or RSV, vaccine for pregnant women: while the CDC’s standing advice still limits the recommendation largely to a September-to-January window in most of the country, the medical groups now say it should be offered into early March in places where RSV circulation runs longer.

The same pattern of delay is affecting updated COVID-19 shots. The FDA has approved revised vaccines, but federal officials did not confirm until this week that orders could be placed through the Vaccines for Children programme, which pays for shots for children without insurance. That uncertainty has complicated fall immunisation planning for doctors, parents and public programmes alike. It also underscores how much of the system depends on the CDC’s ability to turn approvals into practical guidance, something that is now happening only unevenly, if at all.

Another area caught in the crosscurrents is the human papillomavirus, or HPV, vaccine, which protects preteens against several cancers. Researchers have been studying whether one dose may be enough in some groups, especially girls, and the CDC’s former advisory committee had begun reviewing the question before it was dissolved. Kennedy later ordered a cut in the recommended number of doses, but that move was halted by the court order. The American Academy of Pediatrics is also considering whether to revise its own advice, though experts say any eventual agreement may not repair the credibility damage that has already been done. As Jason Schwartz, a Yale University health policy researcher, has noted, even evidence that might otherwise support a policy change now lacks an obvious route into federal guidance, leaving parents and clinicians to navigate a more fragmented system than the one they have relied on for decades.