Under Secretary Robert F. Kennedy Jr., the Department of Health and Human Services (HHS) has ushered in several high-profile changes to vaccine regulations and recommendations in the U.S., often meeting fierce pushback from the medical community and others.
After the U.S. government’s surprise move early this year to ditch routine recommendations for six vaccines in the childhood vaccination schedule—plus several other controversial developments over the last year—a lawsuit from the American Academy of Pediatrics (AAP) and others has dealt a blow to the HHS’ attempts to upend vaccination practices in the U.S.
In a preliminary ruling, a federal judge in Boston blocked significant parts of the HHS’ vaccination agenda, finding that officials acted unlawfully in ushering in certain changes.
The HHS “looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing,” agency spokesman Andrew Nixon said in a statement.
The ruling touches on several high-profile developments from the last year. For instance, last summer, RFK Jr. gutted the roster of the Advisory Committee on Immunization Practices (ACIP), a panel that advises the Centers for Disease Control and Prevention (CDC), drawing intense pushback at the time.
Since then, RFK Jr. has restaffed the panel with his own selections. Before the ruling, the panel was set to meet later this week.
But on Monday, the court found that several recent appointments to the committee may have been made in violation of the Federal Advisory Committee Act. By granting a stay on the appointments, the court effectively prevents the panel from meeting or taking action.
Additionally, after the CDC abruptly dropped its routine recommendations for several vaccines in January, the court found that those changes didn’t follow proper protocol. At that time, universal recommendations for vaccines protecting against hepatitis A and B, influenza, rotavirus, respiratory syncytial virus (RSV) and meningococcal disease were dropped for children.
In his ruling staying recent HHS vaccine moves, District Judge Brian Murphy pointed to procedural missteps made by the government with its changes to ACIP and U.S. vaccine schedules.
“[T]here is a method to how these decisions 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.”
The judge specifically took issue with RFK Jr.’s previous efforts to bypass ACIP to alter immunization schedules for COVID shots and the subsequent gutting and restaffing of the committee with new members last summer, which he argued occurred “without undertaking any of the rigorous screening that had been the hallmark of ACIP member selection for decades.”
“This procedural failure highlights the very reasons why procedures exist and raises a substantial likelihood that the newly appointed ACIP fails to comport with governing law,” he added.
Murphy concluded that AAP and its fellow plaintiffs were likely to succeed in showing that ACIP’s reconstitution and the January changes to the pediatric vaccine schedule violated the Administrative Procedure Act.
In making the changes to the childhood vaccination schedule, the CDC moved to bring U.S. standards more in line with the “international consensus,” RFK Jr. said in a statement at the time. The move followed a memorandum from President Donald Trump and a review of vaccination schedules of several countries by higher-ups in the U.S. healthcare infrastructure, but not the formal ACIP process that has come to define the framework for formulating vaccine recommendations in the U.S. over decades.
Beyond the reversal of the pediatric vaccine schedule changes, it remains unclear what the status of new CDC recommendations around COVID-19 vaccines from last year stand, Richard Hughes IV, lead counsel for the plaintiffs in the case, said during a media briefing Monday.
“We do know that all of the votes taken by [ACIP] since it’s been reconstituted—going back to when they were reconstituted last summer—have been stayed,” he explained.
Next up, Hughes said the plaintiffs hope to proceed to a trial on the merits or “potentially a motion for summary judgment before it goes that far.”
For his part, AAP President Andrew Racine, M.D., Ph.D., hailed the judge’s decision, noting that it has “injected a degree of clarity into what we should be doing with regard to vaccine recommendations that was a little bit muddy up until now.”
“We have been perfectly happy, and we would be perfectly happy to go back to the kind of partnership that we had had for decades with the federal government,” Racine continued, “in which the American Academy of Pediatrics and our recommendations were completely cognizant of what’s going on from the CDC.”
