Delaware residents may enter the next cold and flu season without clear federal guidance on COVID vaccinations and updated influenza shots following a federal court decision that has frozen the nation’s key vaccine advisory committee.
U.S. District Judge Brian Murphy in Boston issued a ruling last month that suspended the operations of the Advisory Committee on Immunization Practices, the expert panel that provides vaccination guidance to the Centers for Disease Control and Prevention.
The judge determined that the majority of committee members selected by Health Secretary Robert F. Kennedy Jr. lacked proper qualifications and ordered their decisions suspended. This action effectively restored the earlier childhood vaccination schedule that Kennedy and his supporters had attempted to overhaul.
The court’s decision has left the CDC operating without a working advisory committee to provide recommendations on new vaccines or updated applications for existing immunizations.
“It’s just uncharted territory,” said Dr. Demetre Daskalakis, who previously served as director of the CDC’s National Center for Immunization and Respiratory Diseases before departing the agency last year in opposition to Kennedy’s vaccine policy changes.
According to Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and long-serving committee advisor, vaccines that receive FDA approval but lack committee recommendations may face insurance coverage issues and exclusion from federal vaccination programs, despite being legally available for prescription.
Kennedy has not announced whether he plans to restructure the advisory panel using his revised committee charter to work around the court decision, challenge the judge’s ruling through appeals, or pursue both strategies.
The Department of Health and Human Services, under Kennedy’s leadership, has not responded to inquiries regarding future plans for the advisory committee or the current status of vaccine recommendations.
Fall Vaccination Season in Question
The most significant uncertainty involves updated COVID-19 vaccines for the upcoming season.
Under typical circumstances, the advisory committee evaluates and updates guidance for influenza and COVID vaccinations during its June session. Annual flu vaccines benefit from established universal recommendations for individuals six months and older, which may eliminate the need for new committee approval this year, according to former CDC officials.
COVID vaccines present a different challenge, as they are also annually updated but target a more recent virus and have a shorter history of use. Under Kennedy’s leadership, the committee has placed particular emphasis on COVID vaccine safety concerns, given his long-standing opposition to vaccination programs.
“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,” explained a former CDC vaccine official who spoke anonymously regarding COVID shot recommendations.
AHIP, representing health insurance companies, has committed to covering all vaccines recommended by the advisory panel as of September 1, 2025, through the end of 2026 — a timeframe preceding major vaccination schedule modifications.
An insurance industry representative indicated that health plans will continue assessing current medical evidence and clinical recommendations from organizations including the American Academy of Pediatrics, the Infectious Diseases Society of America, and the American College of Obstetricians and Gynecologists.
The judge’s suspension order has also created uncertainty around Merck’s Enflonsia, a monoclonal antibody treatment for RSV prevention in infants that received committee approval in June under Kennedy’s appointees. Merck stated the product was not central to the legal challenge.
“We have not heard of any changes to the availability of Enflonsia,” said Claire Hannan, who leads the Association of Immunization Managers, a national organization representing state and local immunization officials.
Approved Vaccines Await Direction
Multiple vaccines that have received Food and Drug Administration approval are now waiting for committee recommendations. These include three RSV vaccines for adults aged 18-49 at elevated risk for severe illness: Pfizer’s Abrysvo, Moderna’s mResvia, and GSK’s Arexvy.
Current RSV vaccination guidelines apply only to adults 75 and older and those aged 50-74 with high risk factors. The committee was also scheduled to determine whether adults 75 and older who have received one RSV vaccination require a second dose.
Additional committee responsibilities have been suspended, including an ongoing evaluation of whether reduced HPV vaccine doses could maintain effectiveness against cervical cancer.
“That’s the type of work the ACIP should be doing,” said Dr. Jose Romero, who previously chaired the committee. “They may be derailed from that.”
The standstill could also impact vaccines anticipated to receive FDA approval later this year.
The committee’s updated charter, released earlier this month, continues to direct the panel to evaluate new vaccines at their first meeting following FDA licensing. However, without an active panel, vaccines could remain on the market indefinitely without federal recommendations.
This situation affects Moderna’s experimental mRNA-based influenza vaccine, which would be the first of its type in the United States. An FDA decision is expected by early August.
Committee recommendations would be necessary if Pfizer and Valneva’s Lyme disease vaccine receives approval. While the vaccine did not meet its primary effectiveness target, it demonstrated approximately 70% efficacy in late-stage trials, and Pfizer has announced plans to seek FDA authorization.
“If the vaccine is not fully recommended and it’s a newer vaccine, will the payers pay?” asked Michael Osterholm, an infectious disease expert at the University of Minnesota. “We don’t have any guarantee of that.”
