A vaccine approved in August, and nobody yet to recommend it

In August the US Food and Drug Administration approved Moderna’s mRNA flu vaccine for adults aged 50 and over¹. In October some of those adults are still paying for it themselves. The reason is not the science. It is an empty committee room.

The gap. A court order halted Health Secretary Robert F. Kennedy Jr.’s overhaul of the CDC’s Advisory Committee on Immunization Practices, ACIP, but no new members have been appointed, so the committee cannot issue recommendations, CIDRAP’s biweekly vaccine-policy review reports¹. Without an ACIP recommendation, insurers are not required to cover a new vaccine¹. In states that allow pharmacists to give only ACIP-recommended vaccines, it may not be available at the pharmacy at all¹.

The calendar. The CDC is now taking nominations for ACIP until 31 December, so a reconstituted committee is unlikely to vote before next year¹. The committee can have up to 19 members, and anyone can apply or be nominated; the health secretary makes the final picks¹. Then comes the slow part. Insurers do not have to cover a newly recommended vaccine until the plan year that starts a full year after the recommendation, so a recommendation made after this December would push required coverage to January 2029 at the earliest for most plans¹.

The stopgap. AHIP, the insurers’ trade group, has pledged that its members will keep covering all vaccines recommended as of September 2025, and the federal government has appealed the ruling¹. That protects the existing schedule, but not vaccines approved since.

The flu shot, briefly. The same review takes apart a Cleveland Clinic preprint now circulating again with a claim that the flu shot raised staff’s risk of flu by 27%¹. That figure comes from the first version; the fourth version reports three estimates, and only the high-activity weeks show a higher rate among the vaccinated¹. Only about two in 100 of the 53,402 employees tested positive over the whole season, and the study measured positive tests, not hospital admissions or deaths, where the vaccine does most of its work¹.

The calm point. None of this is a shortage of medicine. It is a queue in the paperwork, and paperwork can be fixed by people doing ordinary jobs: nominating, appointing, voting, writing coverage rules. If you are in the US and over 50, ask your insurer what it covers before you book. If you are in Europe, your own national committee’s list still decides, and it is published.