A federal judge on Monday temporarily blocked several major moves Health and Human Services Secretary Robert F. Kennedy Jr. has made to upend vaccine policy in the U.S., arguing the changes he and his agency directed likely violated federal law.
The 45-page ruling was issued in response to a lawsuit filed by six medical organizations, including the American Academy of Pediatrics, in July. In it, Brian Murphy, a district court judge in Massachusetts, stalled changes federal health officials made to the childhood immunization schedule in January. Murphy also temporarily halted all the decisions a key vaccine panel has made since Kennedy reformed the committee last year.
That panel, ACIP, will no longer meet this week as planned.
“[T]here is a method to how these decisions historically have been made — a method scientific in nature and codified into law through procedural requirements,” Murphy wrote. “Unfortunately, the government has disregarded those methods and thereby undermined the integrity of its actions.”
“HHS looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing,” HHS spokesman Andrew Nixon wrote in an email to BioPharma Dive.
Over the last year, Kennedy, a prominent vaccine skeptic, has made a series of decisions that have weakened the U.S.’ stance on vaccines for a number of childhood diseases and respiratory infections. Many of those moves came after he fired all 17 members of ACIP and reconstituted the panel with people more aligned with his views, including some without relevant backgrounds.
The new members have rolled back endorsements for multiple common immunizations, among them a dose protecting newborns against hepatitis B infections. They’ve gone against established scientific evidence supporting COVID-19 shots and other immunizations, and indicated plans to closely examine an immune-boosting adjuvant long used in a dozen standard childhood vaccinations.
ACIP members are typically vetted through a rigorous process. In his ruling, Murphy argued the government circumvented that protocol, raising a “substantial likelihood that the newly appointed ACIP fails to comport with governing law.” Murphy added that ACIP’s mandate is to evaluate vaccines and its new members “appear distinctly unqualified” for the task, supporting the plaintiffs’ charge that the panel’s reformation was “arbitrary and capricious.”
Murphy also found likely unlawful the CDC’s abrupt decision in January to narrow the number of universally recommended shots for U.S. children to 11 from the previous 17. The federal government bypassed ACIP in announcing those changes, a “technical, procedural failure” and an indicator of the “abandonment of the technical knowledge and expertise embodied by that committee.”
The AAP and other medical organizations sued HHS last July, after the federal government said COVID vaccines would no longer be recommended for pregnant women or healthy children. In January, the plaintiffs asked the court to halt changes to the vaccine schedule and prevent ACIP from meeting in February. ACIP was set to convene this week after that planned meeting was postponed. The judge’s order leaves unclear when the next gathering will take place.
“The judge recognized that the actions of Secretary Kennedy and [ACIP] are not grounded in science and that they are destructive. We are thrilled that the court has discarded the baseless vaccine schedule changes made by Secretary Kennedy and is blocking [ACIP] from doing further damage to vaccine policy," said Richard Hughes, a partner at the law firm Epstein Becker Green and an attorney for the plaintiffs, in a statement.
On a Monday call with reporters after the ruling, Hughes said the next steps might be determined within a month and a half.
