Americans could enter the next respiratory illness season without clear federal direction on COVID-19 shots and updated flu vaccines after a recent court decision disrupted the nation’s vaccine advisory system, raising uncertainty about whether some new immunizations will be covered by insurance.
The ruling, issued by Boston-based U.S. District Judge Brian Murphy, halted the work of the Advisory Committee on Immunization Practices, the panel that provides guidance to the Centers for Disease Control and Prevention on vaccine use.
Murphy determined that most members of a panel appointed last year by Robert F. Kennedy Jr. lacked proper qualifications and ordered their decisions suspended, effectively reinstating the prior childhood immunization schedule that Kennedy and his allies had sought to overhaul.
As a result, the CDC is currently without a functioning advisory group to issue recommendations on new vaccines or updated uses for existing ones.
“It’s just uncharted territory,” said Dr. Demetre Daskalakis, former director of the CDC’s National Center for Immunization and Respiratory Diseases, who left the agency last year in protest over Kennedy’s moves to rewrite U.S. vaccine policies.
Experts warn that without recommendations from the advisory panel, newly approved vaccines and expanded uses—while still legal—may not be covered by insurers or included in federal programs, according to Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and a longtime adviser to the panel.
Kennedy has not yet announced whether he will attempt to restructure the advisory committee under its revised charter, appeal the ruling, or pursue both options.
The Department of Health and Human Services, which Kennedy oversees, did not respond to inquiries regarding the future of the advisory panel or vaccine guidance.
Uncertainty is particularly high surrounding updated COVID-19 vaccines.
Typically, the advisory panel reviews and revises recommendations for flu and COVID shots during its June meeting. Seasonal flu vaccines already carry a long-standing universal recommendation for individuals six months and older, meaning they may not require a fresh vote this year, according to former CDC officials speaking to Reuters.
COVID-19 vaccines may be treated differently, however, because they target a newer virus and have a shorter history of use. Their safety profile has been a central focus of the advisory panel under Kennedy, who has long been associated with vaccine skepticism.
“You could argue that it’s recommended because it’s on the (immunization) schedule, or that it’s not because the previous recommendations were for the 2025-26 vaccine,” said one former CDC vaccine official, who requested anonymity, of COVID shots.
The health insurance industry group America’s Health Insurance Plans has said it will continue covering vaccines that had been recommended by the advisory panel as of September 1, 2025, through the end of 2026, before major revisions to the schedule were proposed.
An industry source said insurers will continue to rely on the latest medical evidence and clinical guidance from professional organizations such as the American Academy of Pediatrics, the Infectious Diseases Society of America, and the American College of Obstetricians and Gynecologists.
The court’s order has also created uncertainty around Merck’s Enflonsia, a monoclonal antibody treatment designed to prevent RSV infection in infants. The advisory panel had voted in June to recommend the therapy, though Merck has said the product is not central to the legal dispute.
“We have not heard of any changes to the availability of Enflonsia,” said Claire Hannan, executive director of the Association of Immunization Managers, a national group representing state and local immunization officials.
Several vaccines that have already received approval from the Food and Drug Administration are still awaiting advisory panel recommendations. These include three RSV vaccines for adults ages 18 to 49 at elevated risk: Pfizer’s Abrysvo, Moderna’s mResvia, and GlaxoSmithKline’s Arexvy.
At present, RSV vaccines are recommended only for adults 75 and older, as well as those between 50 and 74 who face higher risk. The advisory panel had also been expected to consider whether seniors who already received an RSV shot should get a booster.
Other ongoing work typically handled by the panel has been stalled as well, including a long-term review examining whether fewer doses of the HPV vaccine could still effectively prevent cervical cancer.
“That’s the type of work the ACIP should be doing,” said Dr. Jose Romero, a former ACIP chair. “They may be derailed from that.”
The disruption could also impact vaccines expected to receive FDA approval later this year.
Under its newly issued charter, the advisory panel is still directed to review vaccines at its first meeting following FDA authorization. Without an active panel, however, newly approved products could remain available without any formal federal recommendation.
That includes Moderna’s experimental mRNA-based flu vaccine, which would be the first of its kind in the United States. A decision from the FDA is anticipated by early August.
Recommendations from the advisory panel would also be necessary if a Lyme disease vaccine being developed by Pfizer and Valneva secures approval. Although the vaccine did not meet its primary endpoint, it demonstrated roughly 70 percent effectiveness in a late-stage trial, and Pfizer has indicated it plans to seek authorization.
“If the vaccine is not fully recommended and it’s a newer vaccine, will the payers pay?” said Michael Osterholm, an infectious disease expert at the University of Minnesota. “We don’t have any guarantee of that.”
{Matzav.com}