Originally published by our sister publication Infectious Disease Special Edition

By Gina Shaw

A federal judge dealt a major blow to Health and Human Services Secretary Robert F. Kennedy Jr.’s vaccine policy agenda on Monday, March 16, issuing a preliminary injunction that blocks the administration’s reduced childhood immunization schedule and bars Kennedy’s handpicked Advisory Committee on Immunization Practices (ACIP) members from convening—halting, at least temporarily, what major medical organizations have described as a systematic dismantling of the scientific infrastructure governing U.S. vaccine policy.

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U.S. District Judge Brian E. Murphy of the District of Massachusetts ruled in favor of a coalition of six medical organizations led by the American Academy of Pediatrics (AAP) including the Infectious Diseases Society of America (IDSA), American College of Physicians (ACP), American Public Health Association, Massachusetts Public Health Alliance, and Society for Maternal-Fetal Medicine. ACIP had been set to hold its next meeting March 18-19; that meeting has been postponed, according to an HHS official who responded to an IDSE inquiry.

“I’m very happy,” said Walter Orenstein, MD, a professor emeritus of medicine, pediatrics, epidemiology, and global health at Emory University, in Atlanta, and the former director of the U.S. Immunization Program from 1988 to 2004. “It could be reversed by a higher court, of course, but it’s a real step in the right direction for public health and prevention in this country for the court to question the qualifications of this ACIP panel. It was great to see that the judge understood that they really did violate the processes for determining ACIP membership. I would hate to have to see a polio outbreak or a meningitis outbreak to get people to realize the benefits of vaccination.”

Sharon Nachman, MD, the chief of pediatric infectious diseases at Stony Brook Children’s Hospital, in New York, said the ruling restores what physicians have been fighting to preserve. “The good news is we are protecting America’s children the way we are supposed to, as scientists, as physicians, and as parents,” she said. Looking ahead, Dr. Nachman called for a reconstituted ACIP composed of “conflict-free experts with medical and scientific background who know how to read data, not people cherry-picked because they’ve already made up their mind before they’ve seen any data.”

What the Ruling Does

The ruling stays the January 2026 “Kennedy schedule” and blocks the reconstituted ACIP from meeting. It also invalidates the three votes Kennedy’s ACIP took in 2025, including a June 2025 vote on thimerosal in flu vaccines, a September 2025 vote downgrading adult COVID-19 vaccine recommendations from routine to shared decision-making, and a December vote on the hepatitis B birth dose. The court declined to act on the May 2025 directive removing COVID-19 vaccine recommendations for pregnant women and healthy children, finding the justiciability questions on that claim insufficiently clear at the preliminary stage.

The opinion opened with a sweeping affirmation of the decades of federal investment in U.S. public health. “One extraordinary product of that apparatus has been the eradication and reduction of certain communicable diseases through the development and use of vaccines,” Murphy wrote. “In the words of the Centers for Disease Control and Prevention, ‘vaccines are one of the greatest achievements of biomedical science and public health.’”

The judge found that Kennedy’s actions over the past nine months have amounted to a systematic violation of the procedures that make that apparatus function. “There is a method to how these decisions historically have been made—a method scientific in nature and codified into law through procedural requirements,” he wrote. “Unfortunately, the Government has disregarded those methods and thereby undermined the integrity of its actions. 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. Second, the Government removed all duly appointed members of ACIP and summarily replaced them without undertaking any of the rigorous screening that had been the hallmark of ACIP member selection for decades.”

After Kennedy fired all 17 ACIP members on June 9, 2025, he replaced them in a process the court found took “a few months” and “involved some limited outreach to candidates”—compared with the two years of broad outreach, formal applications, and rigorous vetting that had historically been characteristic of ACIP appointments. The court noted that the administration “failed to issue a Federal Register notice and ignored the year-round online application process” required under ACIP’s own governing documents.

Reviewing each member’s qualifications individually, Murphy concluded that of the 15 current ACIP members, “even under the most generous reading, only six appear to have any meaningful experience in vaccines—the very focus of ACIP.” Six members “appear to lack any expertise or professional qualifications related to vaccines or immunization.” Three others, including ACIP deputy chair Robert Malone, MD, whose only documented vaccine-related experience the court found dated to mRNA research “thirty plus years ago,” appeared to lack the requisite current expertise.

“ACIP is not just a committee of doctors, or even a committee of public health experts; it is a committee specifically dedicated to the ‘use of vaccines and related agents for effective control of vaccine-preventable diseases,’” the judge wrote. “As to that specific function, the newly appointed members appear distinctly unqualified. A committee of non-experts cannot be said to embody ‘fairly balanced points of view’ within the relevant scientific community.”

The January 2026 ‘Kennedy Schedule’

On Jan. 5, HHS issued a memorandum that reduced the number of childhood vaccinations recommended as “routine” from 17 to 11, limiting recommendations for respiratory syncytial virus, hepatitis A, hepatitis B, meningococcal, and dengue vaccines to only high-risk groups, and downgrading others—including COVID-19, influenza, rotavirus, and hepatitis A and B—to “shared clinical decision-making” status for average-risk children. That memo, in turn, was driven by a Presidential Memorandum directing HHS to align the U.S. vaccine schedule with peer nations, and relied on discussions with health officials from Japan, Germany, and Denmark. ACIP was not consulted.

The court found that the agency “lacked authority to issue the January 2026 Memo and, in so doing, acted contrary to law,” noting that Congress has interwoven ACIP’s role throughout the statutory framework governing vaccine policy, including the Affordable Care Act’s requirement that insurers cover ACIP-recommended vaccines at no cost, Medicaid and veterans’ benefit provisions tied to ACIP’s schedule, and the Vaccines for Children Program. “Congress’s mention of ACIP would be rendered pure surplusage if the CDC Director were empowered to act entirely apart from it,” Murphy wrote.

The court also rejected the government’s argument that vaccine schedule decisions are “committed to agency discretion” and therefore unreviewable. In a pointed exchange quoted in the opinion, when defense counsel argued that even an agency policy endorsing the spread of measles would be unreviewable, the court responded: “So even if what the agency was saying is we like communicable diseases and we think you should get more of them, that’s not judicially reviewable?” Defense counsel answered: “No.” Murphy wrote that he “disagrees.”

The administration also argued that its obligation to follow a Presidential Memorandum justified bypassing the usual process. The court rejected this too: “Defendants cannot disregard the AAP’s requirements simply because they are following the President’s orders.”

Public Health Experts and Medical Societies: ‘A Historic and Welcome Outcome’

Medical organizations and public health experts greeted the ruling with relief.

IDSA president Ronald G. Nahass, MD, MHCM, called the ruling an important step toward protecting Americans’ access to lifesaving vaccines. “Infectious diseases doctors remain hopeful that adherence to a scientifically valid process in determining vaccine policy ultimately will be restored. Secretary Kennedy has caused needless confusion and distrust in vaccine guidance, and unless stopped, his actions will continue to result in preventable disease outbreaks.”

“Historic” was the verdict from AAP president Andrew Racine, MD, PhD. “Today’s ruling is a historic and welcome outcome for children, communities, and pediatricians everywhere,” he said in a statement. “This decision effectively means that a science-based process for developing immunization recommendations is not to be trifled with.”

In a press briefing, plaintiffs’ lead counsel Richard Hughes noted the significance of the judge’s acknowledgement of the importance of the scientific method and evidence-based vaccine recommendations. “We are elated with this decision. It is a great victory, not just for vaccines and public health in the United States, but for science. It’s also a major victory for the rule of law.”

ACP president Jason M. Goldman, MD, MACP—who has argued vigorously for evidence-based vaccine science as a liaison member of ACIP, even as those members were removed of their long-valued ability to participate in member work groups—also praised the judge’s decision. “Today’s ruling is a win for public health and reaffirms that national vaccine policy should be guided by rigorous, evidence-based science, not politics,” he said. “Vaccines are critical to maintaining public health and recommendations about their use must be based on the best available data. Scientific consensus and overwhelming evidence demonstrate that vaccines are safe and effective. We are encouraged by today’s injunction and hope that it will mean a return to a transparent and evidence-driven process that safeguards the health of all communities and the best interests of our patients.”

The American Medical Association (AMA) concurred. “Today’s ruling is an important step toward protecting the health of Americans, particularly children. Vaccines are one of the safest and most effective tools in medicine, and strong, science-based immunization policies save lives,” said David H. Aizuss, MD, the chair of the AMA Board, in a statement. “The American Medical Association will continue to stand firmly with physicians, scientists, and public health experts to ensure vaccine recommendations remain grounded in the best available medical evidence and focused on protecting patients.”

In the press briefing, Hughes noted that it is unclear when and how new members might be appointed to ACIP. “The judge refrained from saying exactly how they should have gone about appointing the new committee members and refrained from replacing them himself. I believe that what we’ll see, once we reach the merits in this case, a full ruling on exactly what would be expected in terms of the process that an agency goes through to appoint members of the panel.”

Administration Vows to Appeal

HHS spokesman Andrew Nixon said the department “looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing.”

On his Substack, Dr. Malone decried the ruling in an article titled “The Administrative State vs. the People’s Mandate,” calling it “judicial overreach in real time.”

“A district court order is a delay, not a defeat. The administration has strong grounds for appeal,” he concluded.

For infectious disease clinicians navigating ongoing uncertainty, Monday’s ruling at a minimum restores the framework they depend on while litigation continues. The AAP’s annual childhood immunization schedule, now endorsed by more than 12 national medical societies, remains the science-backed reference for clinical practice. “Parents can continue to turn to the AAP’s childhood vaccine recommendations and talk with their pediatrician about how to best protect their children’s health,” Dr. Racine said.

The sources reported no relevant financial disclosures.