CDC Vaccine Recommendation Process Stalls as mFlusiva Flu Shot Goes Unlisted
核心洞察
The FDA granted full approval to mFlusiva (搜索), the first mRNA-based flu vaccine, for adults ages 50 to 64, but the CDC has issued no recommendation for it.
The CDC said it would maintain last year's flu vaccine endorsements due to legal uncertainties, leaving mFlusiva (搜索) off the list of recommended shots this fall.
A federal judge in March halted Health Secretary Robert F. Kennedy Jr.'s reconstituted vaccine advisory panel and suspended his reduction of the childhood immunization schedule.
The Food and Drug Administration (搜索) has granted full approval to mFlusiva (搜索), the first influenza (搜索) vaccine built on the mRNA technology that was central to ending the COVID-19 (搜索) pandemic, for people ages 50 to 64. The Centers for Disease Control and Prevention (搜索), the federal agency responsible for telling doctors and the public how to use vaccines, has made no recommendation on it.
The CDC this month quietly posted that it will maintain its flu vaccine endorsements from last year because of "legal uncertainties and inquiries." As a result, mFlusiva (搜索) is not among the flu vaccines listed as recommended to the public this fall. The medical societies are recommending it as an option.
The inaction marks a break from longstanding practice and illustrates how the agency's vaccine review-and-recommendation process has stalled over the past year. Federal guidance on new vaccines has stopped, efforts by vaccine-wary officials in the Trump administration to scale back shot recommendations have been put on hold, and public discussion of vaccine policy questions that might cross political divides has diminished.
A Six-Decade Committee Shut Down
For 60 years, the Advisory Committee on Immunization Practices (搜索) guided the CDC's vaccine recommendations. The committee met publicly, reviewed vaccine data and sought input from health groups. Its votes went to the CDC director, who almost always adopted them as government guidance, leading public and private insurers to pay for the shots.
Health Secretary Robert F. Kennedy Jr. dismissed the committee last year and replaced it with a group that included several anti-vaccine voices. Controversial decisions followed, prompting a lawsuit from the American Academy of Pediatrics and other medical groups. In March, a federal judge said Kennedy likely violated federal procedures, stopped his panel from holding further meetings and suspended his decision to reduce the number of vaccines recommended for children.
"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," said Jason Schwartz, a Yale University (搜索) health policy researcher who studies government health agencies.
Dr. Jason Goldman, president of the American College of Physicians (搜索), said he hoped the ruling "will mean a return to a transparent and evidence-driven process that safeguards the health of all communities and the best interests of our patients."
Medical Societies Fill the Gap
With the reconstituted committee shut down by court order, doctors' groups that previously collaborated with ACIP have gone their own way. Working with a University of Minnesota researcher, they have debated privately the kind of medical evidence formerly presented at ACIP meetings and issued their own recommendations.
The trade association for private health insurers decided to heed the medical societies' choices, and insurers have continued to pay for shots those organizations recommend. Many of the groups' recommendations match prior ACIP and CDC positions, but they have also made updates of their own.
ACIP previously recommended that a vaccine against respiratory syncytial virus (搜索), which can be dangerous to newborns, be given to women late in pregnancy between September and January in most of the U.S., to coincide with peak RSV season. Because RSV season sometimes remains active longer, the medical groups recently said the shot should be offered to those women through the beginning of March.
"We all recognized this needs to evolve," Chris Regal, director of clinical innovation at America's Health Insurance Plans (搜索), said in a recent webinar. The official CDC guidance remains unchanged.
Coverage Decisions and HPV Reassessment
Another ACIP function was to vote on whether certain vaccines should be covered by Vaccines for Children, a government program that pays for shots for children without health insurance. The FDA approved updated COVID-19 (搜索) vaccines, but as fall vaccination campaigns got underway the government would not say whether the VFC program would pay for those shots. Officials confirmed only this week that orders could be placed through the program.
The reassessment of HPV (搜索) vaccine dosing has also been derailed. Two HPV shots are recommended for preteens to prevent certain cancers, but recent research has suggested one shot could be enough, at least for girls. In 2024, ACIP formed a working group to begin reassessing the recommendations. That work stopped when Kennedy fired the entire committee, and in January he ordered on his own that the number of recommended doses be reduced to one as part of a contraction of the childhood vaccination schedule. The judge's order suspended that decision.
Experts are trying to better understand the timing and duration of protection from a single dose, particularly in boys. The American Academy of Pediatrics is weighing a change to its HPV (搜索) vaccination recommendations and could reach a conclusion later this year, said the AAP's Dr. James Campbell.
It is possible the medical societies will end up agreeing with Kennedy on how many HPV (搜索) shots make sense, but that might not resolve the current situation, Schwartz said.
"The credibility of the Trump administration, when it comes to vaccine recommendations, is so compromised in the eyes of the mainstream medical and public health communities," he said, "that even recommendations that might align with where the public health community was trending are likely to be viewed with skepticism or distrust."
The administration is also considering changing the federal government's categories for vaccine recommendations. No specific proposal has been released, and a Department of Health and Human Services (搜索) spokesperson did not respond to questions about what is being contemplated. Public comments were due earlier this week.
An alliance of 15 Democratic state governors said the proposed changes are likely to increase confusion and administrative complexity. "It's Governors and their residents who bear the brunt of any increased disease outbreaks due to confusion related to hastily made federal changes," Angela Botticella, managing director of the Governors Public Health Alliance, said in a statement.