A federal judge in Boston on Monday stalled a key part of Health Secretary Robert F. Kennedy Jr.’s campaign to reshape U.S. vaccine policy, saying the Trump administration likely violated the law.
Judge Brian E. Murphy issued a preliminary ruling that President Kennedy’s reconstitution of a key vaccine advisory committee and changes to the childhood vaccination schedule made in January were likely illegal. Specifically, the court ruled that these policy changes violated the Administrative Procedure Act, which governs how federal agencies should consider and implement policy changes.
The decision is not final, but it is a blow to the Trump administration’s overhaul of the country’s vaccine policy, even though the reform agenda is still underway. The court’s final decision and the administration’s response to the court order will likely have far-reaching implications for public health in the United States.
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The next meeting of the Advisory Committee on Immunization Practices was scheduled for this week, but was postponed due to the ruling.
“All of this shows that there is a way to know how these decisions have been made historically, a method that is scientific in nature and codified into law through procedural requirements. Unfortunately, the government ignored those methods, thereby undermining the integrity of its actions,” Murphy wrote in the 45-page decision. “First, the government’s decision to bypass ACIP and change the vaccination schedule is itself a technical and procedural failure, but also strongly indicative of a more fundamental problem: an abandonment of the technical knowledge and expertise that the commission embodied.”
Richard Hughes IV, a partner at Epstein Becker & Greene who represented plaintiffs in the case, including the American Academy of Pediatrics, called the decision “a major victory for science, public health and the rule of law.”
“We won in every way possible,” Hughes told STAT.
The government is expected to appeal this ruling.
“HHS expects this judge’s ruling, as well as his other attempts to thwart the Trump administration, to be overturned,” HHS spokesman Andrew Nixon said in a statement.
The current ACIP is made up of people who sympathize with President Kennedy’s criticism of vaccines. President Kennedy dismissed all members of the commission last June, arguing that it would restore confidence in vaccines.
Noel Brewer, one of the experts fired from the commission, welcomed Monday’s ruling.
“It’s time for someone to reverse the runaway ACIP,” said Brewer, a health behavior professor at the University of North Carolina. “This virus is harming people not only in the United States, but also in other countries that are following the United States. Today is a good day for public health.”
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The judges’ opinions often considered the experience of new committee members and determined that they did not have the expertise needed to inform federal policy on vaccinations. In several cases, the court found that there was “no evidence in the record” that the new members had “relevant vaccine-related experience or expertise.”
While the justices are willing to believe that the current members are qualified, the defendants pointed out that the court has “provided no basis” for evaluating their expertise.
Robert Malone, vice chairman of the commission, disputed the court’s analysis, saying his public record was not sufficient to prove he had the “required experience” to lead the group. Malone argued in an online post that the findings were “factually incorrect” and showed the court either did not adequately consider his experience or presented it in the “most unfavorable light possible.”
The judge also took issue with the Trump administration’s “lack of formality and process” in reshaping the commission, noting that it previously took two years to add new members to the commission and extensive outreach to candidates.
ACIP was scheduled to meet on Wednesday and Thursday, but the court blocked any vote by the committee as currently constituted. The agenda has not yet been posted, but a Federal Register notice for the meeting suggests there could be votes on COVID-19 vaccine injuries and long-term COVID-19 issues, as well as the methodology the committee will use to develop its recommendations.
Still, the ruling does not cover all of the Trump administration’s vaccine policy changes. For example, research funding from the federal government and approval of new vaccines by the Food and Drug Administration are not directly related.
The decision comes as the White House grapples with withdrawing from vaccine policy reform, a key issue for President Kennedy, who previously founded and led the anti-vaccination group Children’s Health Defense. Government officials are increasingly considering the political risks of a vaccine-focused agenda in a critical election year, and those concerns may be factored into the administration’s response to the ruling.
Still, at least one member of the committee, Mr. Malone, was considering how the administration might overturn the ruling.
“The district court’s order is a delay, not a defeat,” he wrote shortly after the decision was announced. “The administration has strong grounds for appeal.”
Helen Branswell contributed reporting.
