FDA Approved a New Flu Vaccine in August. The CDC Still Won't Recommend It.

The federal system that has told American doctors and patients which vaccines to use, and when, for the past 60 years has effectively stopped functioning. The clearest sign came this month, when the Food and Drug Administration's approval of the first mRNA flu vaccine ran into a Centers for Disease Control and Prevention that would not say whether anyone should get it.

The vaccine, MFLUSIVA, made by Moderna, won FDA approval on August 5 for adults 50 and older, based on clinical trial data the agency's own reviewers said showed the shot worked better than a standard-dose flu vaccine in the 50-to-64 age group. Under ordinary circumstances, a new vaccine like this would go next to the CDC's Advisory Committee on Immunization Practices, known as ACIP, which would review the data, vote on a recommendation and hand it to the CDC director for sign-off. That recommendation would then determine whether insurers cover the shot at no cost and whether pharmacies stock it.

None of that happened. Instead, the CDC quietly posted a notice this month saying it would simply carry over last year's flu vaccine guidance, citing what it called "legal uncertainties and inquiries." MFLUSIVA is not on the list of vaccines the agency recommends for the fall. Medical societies, filling the vacuum, are recommending it anyway.

The numbers

The gap between what federal regulators have approved and what federal health officials will endorse is no longer a one-vaccine problem. According to reporting this week and a review of the CDC's own ACIP recommendations page, the committee's most recent adopted guidance dates to July 22, 2025, covering the 2025-2026 flu season; as of this weekend the page carries nothing for 2026-2027, even though the 2026-2027 flu season has already begun in CDC's own materials.

• 60 years: how long ACIP had operated as the government's standing vaccine advisory panel before it was overhauled
• August 5, 2026: date the FDA approved MFLUSIVA under a traditional approval pathway for ages 50 to 64
• March 2026: when a federal judge ruled Health Secretary Robert F. Kennedy Jr. had likely violated federal procedure in restructuring the committee
• 15: the number of Democratic governors who have formed a rival public-health coordinating body in response to the standoff

Beyond the flu shot, the same holdup is affecting RSV vaccine timing for pregnant women, the government's Vaccines for Children program's coverage of updated COVID-19 vaccines, and a stalled reassessment of HPV vaccine dosing for adolescents.

How the process broke down

ACIP was created in 1964 and had, for decades, followed a predictable routine: public meetings, staff presentations of safety and efficacy data, input from pediatricians' and physicians' groups, then a vote. The CDC director almost never overruled the committee's recommendation once it was made.

Kennedy, who has spent years questioning the safety of vaccines including mRNA-based ones, dismissed the entire committee last year after being confirmed as health secretary and replaced its members with a new panel that included several vaccine skeptics. The reconstituted committee moved to cut the recommended number of childhood vaccines and, in January, Kennedy unilaterally ordered a reduction in the recommended HPV vaccine schedule from two doses to one.

That set off a lawsuit from the American Academy of Pediatrics and other medical organizations. In March, a federal judge sided with the doctors' groups, finding that Kennedy had likely violated federal rulemaking procedures. The court barred the reconstituted panel from holding further meetings and put the HPV dosing change on hold. Nearly seven months later, no replacement process has taken its place — leaving the government's vaccine recommendation machinery paused rather than restarted.

Who is affected

The practical effect falls first on people deciding this fall whether to get a flu shot, and on the doctors advising them. Adults age 50 to 64 weighing MFLUSIVA have no CDC recommendation to point to, only guidance from outside medical societies. Pregnant women seeking RSV vaccination face a narrower CDC-endorsed window, September through January, even though medical groups now advise availability through March. Parents of adolescent girls and boys are left without updated federal guidance on HPV dosing, at a time when researchers say more data are still needed on how long a single-dose regimen protects boys in particular.

The vacuum is not confined to the flu shot fight. A separate news organization's on-the-ground reporting on local health workers going door to door to contain the nation's worst measles outbreak since 1992 describes county health departments improvising outreach campaigns with little federal coordination, the same fragmented pattern now playing out around this fall's flu vaccine.

Insurers are caught in the middle as well. Coverage determinations have traditionally tracked ACIP recommendations closely, under rules that require most private plans to cover ACIP-recommended vaccines without cost-sharing. With no updated recommendation to rely on, insurers are increasingly looking past the CDC to the position statements issued by medical societies instead.

Reaction

Physician groups describe an environment where they are, in effect, doing the CDC's job themselves. Dr. Jason Goldman, president of the American College of Physicians, said restoring the normal process would matter because it would mean "a return to a transparent and evidence-driven process that safeguards the health of all communities and the best interests of our patients."

"We find ourselves at a point where even if credible evidence [for a new vaccine policy] has reached a tipping point, we don't have an obvious mechanism that can formalize that change." — Jason Schwartz, health policy researcher, Yale School of Public Health

Schwartz, who studies vaccine policy, said the disruption goes beyond any single vote or committee roster. Even guidance that might otherwise be uncontroversial is now viewed warily, he said, because "the credibility of the Trump administration, when it comes to vaccine recommendations, is so compromised" in the eyes of the mainstream medical community that recommendations aligned with where public health experts were already trending are "likely to be viewed with skepticism or distrust."

Insurers, too, say the old arrangement needs rebuilding. "We all recognized this needs to evolve," said Chris Regal, director of clinical innovation at America's Health Insurance Plans, the industry's trade association, describing discussions among health plans about how to handle vaccine coverage decisions without reliable federal sign-off.

State officials have organized their own response. A group describing itself as the Governors Public Health Alliance, whose initial membership consists of the governors of 14 states and Guam, formed this year to coordinate public health guidance independent of federal channels. Angela Botticella, the alliance's managing director, said governors have the most direct stake in the outcome: "It's Governors and their residents who bear the brunt of any increased disease outbreaks due to confusion related to hastily made federal changes."

What happens next

There is no fixed timetable for ACIP to resume normal operation. The Trump administration is reportedly considering changes to how the federal government categorizes vaccine recommendations altogether — a move that could reshape insurance coverage rules more broadly — though the Department of Health and Human Services has not detailed a specific proposal or responded publicly to questions about what it is contemplating.

In the meantime, MFLUSIVA remains available by prescription for adults 50 and older this flu season, but without the CDC recommendation that normally makes a vaccine a default part of an annual checkup. The FDA's own approval materials lay out the clinical basis for the shot in detail the agency itself considers sufficient. What is missing is the second signature: a CDC recommendation that tells providers, insurers and patients what to do with that approval. Until ACIP meets again in a form the courts will accept, that signature is not coming, and the season's vaccine guidance will keep arriving, as it has all year, from medical societies and state health departments rather than from Atlanta.