Undersecretary Robert F. Kennedy Jr. introduced several high-profile changes to U.S. vaccine regulations and recommendations, often met with fierce opposition from the medical community and others.
After the U.S. government took the surprising action earlier this year to eliminate routine recommendations for six vaccines in childhood immunization schedules, and following several controversial developments last year, lawsuits from the American Academy of Pediatrics (AAP) and others have dealt a blow to HHS’ attempts to upend immunization practices in the United States.
In a preliminary ruling, a federal judge in Boston blocked key parts of HHS’ vaccination program, finding that the agency acted illegally in implementing certain changes.
Health Department spokesman Andrew Nixon said in a statement that the department “looks forward to the judge’s ruling being overturned, as well as other attempts to thwart the Trump administration’s rule.”
The ruling touches on several high-profile events from last year. Last summer, for example, RFK Jr. watered down the roster of the Advisory Committee on Immunization Practices (ACIP), a committee that advises the Centers for Disease Control and Prevention (CDC), sparking intense backlash at the time.
Since then, RFK Jr. has reorganized the panel at his own choosing. Ahead of the ruling, the committee was scheduled 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 Committees Act. By granting a stay of appointment, the court effectively prevents the panel from meeting or taking any action.
Additionally, after the CDC abruptly withdrew routine recommendations for several vaccines in January, the court found those changes did not follow proper procedures. At that time, universal childhood recommendations for vaccines to prevent hepatitis A and B, influenza, rotavirus, respiratory syncytial virus (RSV), and meningococcal disease were discontinued.
In his ruling disallowing HHS’s recent vaccination drive, District Judge Brian Murphy pointed to procedural errors made by the government regarding ACIP and changes to the U.S. vaccination schedule.
“Here is a way to show how these decisions were made, an essentially scientific method that is codified into law through procedural requirements,” Murphy wrote. “Unfortunately, the government ignored these measures, thereby undermining the integrity of its actions.”
The judge took particular issue with RFK Jr.’s previous efforts to circumvent ACIP and reschedule COVID-19 vaccinations, and his subsequent abolition of the committee last summer and reassignment of new members, arguing that this was done “without any of the rigorous vetting that has been the hallmark of selecting ACIP members for decades.”
“This procedural failure highlights the very reason the procedure exists and raises the substantial possibility that the newly appointed ACIP will not be complying with applicable law,” he added.
Murphy concluded that AAP and its fellow plaintiffs are likely to succeed in showing that the ACIP reorganization and January changes to the childhood vaccination schedule violate the Administrative Procedure Act.
In changing the childhood immunization schedule, RFK Jr. said in a statement at the time that the CDC was moving to bring U.S. standards more in line with “international consensus.” The move followed a memorandum from President Donald Trump and a review of several countries’ vaccination schedules by top officials in the U.S. health care infrastructure, but did not follow the formal ACIP process that has come to define the framework for developing vaccine recommendations in the U.S. for decades.
Beyond the rescheduling of childhood vaccines, the status of the CDC’s new recommendations for last year’s COVID-19 vaccines remains unclear, Richard Hughes IV, lead attorney for the plaintiffs in the case, said at a media conference Monday.
“We know that since[ACIP]was reconstituted, all the votes that[ACIP]has received going back to when it was reconstituted last summer have been maintained,” he explained.
Next, Hughes said the plaintiffs hope to proceed to trial on the merits or “maybe a motion for summary judgment before we get that far.”
AAP President Andrew Racine, M.D., praised the judge’s decision, noting that it “brings some clarity to what we should do regarding vaccine recommendations, which have been a little vague.”
“We’re completely happy and absolutely delighted to get back to the kind of partnership that we’ve had for decades with the federal government,” Racine continued, “where the American Academy of Pediatrics and our recommendations were fully aware of what was going on from the CDC.”
