A federal judge in Boston on Monday stalled major parts of health secretary Robert F. Kennedy Jr.’s campaign to remake vaccine policy in the U.S., saying the Trump administration had likely violated the law.
Judge Brian E. Murphy issued a preliminary ruling finding that Kennedy’s reconstitution of a key vaccine advisory panel, and changes made to the childhood vaccine schedule in January, were likely illegal. Specifically, he ruled, those policy changes violated the Administrative Procedure Act, which governs how federal agencies ought to consider and implement policy changes.
The decision, though not final, is a blow to the Trump administration’s overhaul of the nation’s vaccine policies — even as its reform agenda remains in progress. The final decision from the court, as well as the administration’s response to the court order, is likely to have far-reaching implications for public health in the United States.
The next meeting of the Advisory Committee on Immunization Practices was scheduled for this week, but has been postponed due to the ruling.
“This is all to say that there is a method to how these decisions historically have been made — a method scientific in nature and codified into law through procedural requirements. Unfortunately, the Government has disregarded those methods and thereby undermined the integrity of its actions,” Murphy wrote in his 45-page decision. “First, the Government bypassed ACIP to change the immunization schedules, which is both a technical, procedural failure itself and a strong indication of something more fundamentally problematic: an abandonment of the technical knowledge and expertise embodied by that committee.”
Richard Hughes IV, a partner for Epstein Becker & Green who was representing the plaintiffs in the case, including the American Academy of Pediatrics, called the ruling a “tremendous victory for science, for public health, and for the rule of law.”
“We prevailed in every way we could,” Hughes told STAT.
The government is expected to appeal the ruling.
“HHS looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing,” HHS spokesperson Andrew Nixon said in a statement.
The current ACIP is stacked with people who share Kennedy’s criticism of vaccines. Kennedy fired the entire previous slate of the committee’s members last June in a move he argued would help to restore confidence in vaccines.
Noel Brewer, who was among the experts fired from the committee, welcomed Monday’s ruling.
“It’s high time that someone brought the runaway ACIP to heel,” said Brewer, a professor of health behavior at the University of North Carolina. “It’s been doing damage to people in the United States, as well as other countries that follow the U.S.’s lead. This is a good day for public health.”
In his opinion, the judge reviewed the experience of the newly added members of the committee, often determining that they don’t have the needed expertise to inform federal policy on vaccinations. “There is no evidence in the record,” the court found in multiple instances, that the new members have “any relevant vaccine-related experience or expertise.”
The judge was open to being convinced that the current members are qualified, he said, but noted that the defendants “provided no basis” for the court to assess their expertise.
The deputy chair of the committee, Robert Malone, took issue with the court’s analysis — which said his public record was not enough to prove he had the “requisite experience necessary” to lead the group. In an online post, Malone argued the finding was “factually incorrect,” and shows the court either didn’t fully review his experience or presented it in “the most unfavorable light possible.”
The judge also took issue with the “lack of formality and process” with which the Trump administration remade the committee, noting that adding new members to the panel previously took two years and broad outreach for candidates.
Murphy noted the panel lacked the expertise it needed to function, though it may prove challenging to find new members that both meet those needs and align with Kennedy’s policy goals. “It is also almost impossible to find anyone with real and legitimate experience in vaccinology and immunology, someone who’s an actual expert in those areas, who agrees with the direction that the current HHS administration is trying to go with vaccines,” said Brian Dean Abramson, a vaccine law professor at the University of Houston Law Center and Florida International University.
Kennedy’s ACIP “was treated more like a public relations exercise more than it was ever treated as an effort to obtain any kind of expertise or ability in the relevant field,” he added.
There are also longer-term questions surrounding the panel, and how it can rebuild trust with professional societies and states — 28 states have already altered their guidance to not follow HHS or ACIP’s recommendations.
ACIP was scheduled to meet on Wednesday and Thursday, but the court blocked any votes by the committee as it is currently constituted. No agenda has yet been posted, but the Federal Register notice of the meeting suggested votes might take place on Covid-19 vaccine injuries and long Covid issues, as well as on the methodology the committee will use to formulate recommendations.
Throughout the case, the government has argued the changes in question were not “final agency actions” and thus should not be reviewed by the court. But Murphy wrote that the changes have legal ramifications, and are thus open to legal challenges. The vaccine schedule determines what decisions health care providers might be liable for, and which vaccines are covered by federal programs.
In the decision, Murphy quoted an exchange from a hearing in February where he asked if the Department of Justice felt it would be reviewable if Kennedy called for Americans to attend measles lunches to get exposed to the disease. Isaac Belfer, the DOJ attorney, said it would be “committed to agency discretion by law.” To which Murphy wrote, “Suffice it to say that the Court disagrees.”
Still, the ruling does not cover all of the Trump administration’s changes to vaccine policy. Research funding from the federal government and approvals for new shots by the Food and Drug Administration, for example, aren’t directly implicated.
The decision comes as the White House has worked to move away from vaccine policy reforms, a signature issue for Kennedy, who previously created and led the anti-vaccine group Children’s Health Defense. Top officials have increasingly weighed the political risk of a vaccine-heavy agenda in a key election year — and those concerns could factor into the administration’s reaction to the ruling.
“There seems to be some reluctance on the part of the White House from focusing too much on the vaccine issue right now, right? Whether they really want to go to the Supreme Court on this, I don’t know,” said Wendy Parmet, a law professor at Northeastern University who was involved in submitting an amicus brief in the case. It would also be difficult for the administration to make an emergency appeal to the high court, given they have argued the changes in question are just recommendations.
Still, at least one member of the committee, Malone, was considering how the administration might overturn the ruling.
“A district court order is a delay, not a defeat,” he wrote just after the ruling was released. “The administration has strong grounds for appeal.”
Helen Branswell contributed reporting.
