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

The approval of mFlusiva has exposed a widening gap in US vaccine policy, with the CDC unable to issue fresh recommendations after its advisory process was disrupted.

The federal vaccine policy machinery in the United States has fallen into disarray just as a new flu shot reaches the market. The Food and Drug Administration has approved mFlusiva, the first mRNA-based influenza vaccine for older adults, but the Centres for Disease Control and Prevention has not issued a recommendation for its use, leaving doctors and patients without the guidance that usually follows an approval. According to the FDA, the vaccine is authorised for adults aged 50 and over as protection against influenza A and B, with the agency’s own materials outlining the supporting evidence and prescribing information.

That gap reflects a wider breakdown in vaccine policymaking after Health and Human Services Secretary Robert F. Kennedy Jr. moved to overhaul the long-established advisory process used by the CDC. For decades, the Advisory Committee on Immunization Practices reviewed vaccine data in public, voted on recommendations and helped determine which shots insurers would cover. But after Kennedy dismissed the panel and replaced it with members that included anti-vaccine voices, a lawsuit from medical groups led to a federal court order halting further meetings and suspending some of his changes, according to the Associated Press.

The result has been an unusual split between official federal guidance and the recommendations now coming from medical societies. Organisations that once worked through the CDC’s process have begun issuing their own advice, often alongside researchers at the University of Minnesota, while private insurers have largely followed suit. In the case of the RSV vaccine for pregnant women, for example, medical groups have widened the window of recommended use beyond the federal guidance because infection season can run later than the CDC’s existing timing.

The same confusion is now affecting the new flu vaccine. Although the FDA has approved mFlusiva for older adults, the CDC has quietly said it is keeping last year’s flu vaccine endorsements in place because of legal uncertainties, meaning the shot does not appear on the agency’s current public list of recommended vaccines for this autumn. Medical societies, meanwhile, are listing it as an option, leaving a vaccine that has cleared one major federal hurdle still waiting for the next one. The FDA’s approval page says the vaccine is intended for adults 50 and older and provides the agency’s clinical reviews and patient information.

Other unresolved questions are piling up as well. The government has confirmed that updated COVID-19 vaccines can be ordered through the Vaccines for Children programme, but only after weeks in which it would not say whether the programme would cover them. A review of the human papillomavirus vaccine, which began before Kennedy removed the committee, was interrupted, and his separate move to cut the recommended number of doses to one remains on hold under the court order. Public health specialists say the longer these decisions stay unresolved, the more difficult it becomes to restore confidence in federal vaccine advice.