By Julie Steenhuysen
CHICAGO, April 21 (Reuters) - Americans may face the next respiratory disease season without clear guidance for COVID shots and updated flu vaccines after a federal court ruling last month left several vaccines in limbo, and raised questions about whether some newly approved products would be covered by insurers.
The decision by Boston-based U.S. District Judge Brian Murphy froze the work of the Advisory Committee on Immunization Practices, the panel that advises the U.S. Centers
for Disease Control and Prevention on how vaccines should be used.
Murphy ruled that most members of a panel appointed last year by Robert F. Kennedy Jr. were unqualified and ordered that their votes be put on hold, effectively restoring the previous childhood immunization schedule that the U.S. Health Secretary and his allies had sought to revamp.
The ruling leaves the CDC without a functioning advisory body to recommend new vaccines or updated uses of 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.
Without ACIP recommendations, newly licensed vaccines and expanded indications — while legal to prescribe — may not be covered by insurers or included in federal programs, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and longtime ACIP adviser.
Kennedy has yet to say whether he will reconfigure the panel, using his revamped ACIP charter to circumvent the court ruling, appeal the judge's order, or both.
The Department of Health and Human Services, which Kennedy leads, did not respond to requests for comment on plans for ACIP or the status of vaccine recommendations.
AUTUMN COVID AND FLU SHOTS
The biggest question mark surrounds updated COVID-19 vaccines.
In a normal year, ACIP reviews and updates recommendations for flu and COVID shots during its June meeting. Seasonal flu vaccines have a long-standing universal recommendation for everyone six months and older, which means they may not require a new ACIP vote this year, former CDC officials told Reuters.
That may not be the case for COVID vaccines, which are also modified each year but target a newer virus and have a shorter track record of use, they said. The safety of COVID vaccines has been a major focus of ACIP under Kennedy, a longtime anti-vaccine activist.
"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.
AHIP, the health insurance trade organization, has pledged to cover all vaccines that had been recommended by the vaccine advisory panel as of September 1, 2025, through the end of 2026 - a period before major changes to the vaccine schedule had been made.
An insurance industry source said health plans this year and beyond will continue evaluating the latest medical evidence and clinical guidelines from groups such as the American Academy of Pediatrics, the Infectious Diseases Society of America and the American College of Obstetricians and Gynecologists.
The judge's stay order also raised questions about Merck's Enflonsia, a monoclonal antibody treatment for preventing RSV infection in infants. The Kennedy-appointed ACIP voted in June to recommend the treatment. Merck said the product was not a focus of the litigation.
"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 organization of state and local immunization officials.
VACCINES AWAITING GUIDANCE
Several vaccines already approved by the Food and Drug Administration await ACIP recommendations. They include three RSV vaccines for adults aged 18–49 who are at increased risk of severe disease — Pfizer's Abrysvo, Moderna's mResvia and GSK's Arexvy.
Currently, respiratory syncytial virus vaccines are recommended only for adults aged 75 and older and for adults aged 50–74 at high risk. ACIP was also due to advise on whether adults 75 and older who already received an RSV shot will need a second dose.
Other work typically handled by ACIP has also been put on hold, including a long-running review of whether fewer doses of the HPV vaccine could still 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 paralysis could also affect vaccines expected to win FDA approval later this year.
ACIP's new charter, issued earlier this month, still guides the panel to review new vaccines at its first meeting after FDA licensure. If no panel is in place, however, vaccines could linger on the market without any federal recommendation.
That includes Moderna’s experimental mRNA-based flu vaccine, which would be the first of its kind in the United States. An FDA decision is expected by early August.
ACIP recommendations would be needed if Pfizer and Valneva's Lyme disease vaccine wins approval. The vaccine missed its primary goal but showed about 70% efficacy in a late-stage trial, and Pfizer has said it plans to seek FDA 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.”
(Reporting by Julie Steenhuysen in Chicago; Editing by Michele Gershberg and Bill Berkrot)
