A federal court order has halted the work of a key U.S. vaccine advisory panel, disrupting the system that guides COVID-19, flu and other immunization recommendations and raising uncertainty over insurance coverage for newly approved vaccines, according to Reuters reporting on Tuesday.
U.S. District Judge Brian Murphy of the District of Massachusetts issued a ruling that paused the Advisory Committee on Immunization Practices (ACIP), finding that most members appointed under Health and Human Services Secretary Robert F. Kennedy Jr. were likely unqualified. The order effectively blocks the panel from issuing new recommendations while litigation proceeds and reinstates prior immunization guidance on an interim basis.
A Systematic Dismantling
Kennedy dismissed every sitting ACIP member in June 2025, replacing them with individuals skeptical of COVID-19 vaccine mandates, then added five more without rigorous vetting in September. Trump announced on Truth Social a reduction in recommended vaccines from 72 to 11. Pfizer Inc. (NYSE:PFE) CEO Albert Bourla called Kennedy’s stance “anti-science.”
Autumn Vaccine Season At Risk
In a normal year, ACIP reviews and updates recommendations for COVID and flu shots at its June meeting. Seasonal flu vaccines carry a long-standing universal recommendation and may not require a new ACIP vote, according to Reuters. COVID vaccines, however, are modified annually and carry a shorter track record, leaving their recommendation status legally ambiguous.
AHIP, the health insurance trade organization, has pledged to cover all vaccines recommended by ACIP as of September 1, 2025, through the end of 2026. Beyond that window, coverage decisions remain uncertain.
Approved Vaccines Left Without Federal Guidance
Several FDA-approved vaccines are now awaiting ACIP recommendations they may not receive. Three RSV vaccines for adults aged 18 to 49 at elevated risk Pfizer Inc.’s (NYSE:PFE) Abrysvo, Moderna Inc.’s (NASDAQ:MRNA) mResvia, and GSK Plc’s (NYSE:GSK) Arexvy, are currently recommended only for adults 75 and older and high-risk adults aged 50 to 74.
Merck & Co. Inc.’s (NYSE:MRK) Enflonsia, a monoclonal antibody approved to prevent RSV in infants, also faces uncertainty following the court order, though Merck has said the product was not a focus of the litigation.
A long-running ACIP review of whether fewer HPV vaccine doses could still prevent cervical cancer has also been paused.
Pipeline Products At Risk
The paralysis extends to pipeline vaccines. Moderna’s experimental mRNA-based flu vaccine, which would be the first of its kind in the United States, awaits an FDA decision expected by early August. Without a functioning ACIP, it could enter the market without a federal recommendation.
Pfizer and Valneva SE’s (NASDAQ:VALN) Lyme disease vaccine, which showed roughly 70% efficacy in a late-stage trial, faces the same gap if it wins FDA approval.
Kennedy has yet to say whether he will reconfigure the panel, appeal the ruling, or both. His appearance before the House Ways and Means Committee earlier this month, where he defended a proposed 12.5% cut to the HHS budget, drew sharp congressional criticism over vaccine policy changes and declining vaccination rates.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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