BREAKING NEWS

Court halts changes to childhood vaccine schedule and the newly reconstituted vaccine committee

Today, a U.S. District Court in Massachussetts ordered a stay:

• of the January 2026 Memo that revised the CDC’s childhood immunization schedule;
• of the appointments of 13 of the members appointed to the newly reconstituted ACIP; and
• of all votes taken by the now-stayed ACIP since June of 2025.

A group of plaintiffs led by the American Academy of Pediatrics filed suit against Robert F. Kennedy, Jr. in his official capacity and certain other defendants regarding the failure of HHS and the CDC to follow the Administrative Procedures Act (APA) and the Federal Advisory Committee Act (FACA) in its reconstituting of the Advisory Committee on Immunization Practices (ACIP) of the CDC and its issuance of changes to the childhood vaccine schedule.

This decision was not the final decision in the case, which is ongoing, but rather the partial granting of a motion brought by the plaintiffs requesting a preliminary injunction in order to halt the actions that plaintiffs asserted were in violation of law until the case could be heard and decided.

The Court took note that the ACIP was founded in 1964 and plays an active role in providing expert guidance on the clinical use of vaccines. The ACIP has been a non-partisan group of experts relevant to setting guidance on the clinical use of vaccines.

Congress has, in turn, recognized the importance of ACIP and now a number of statutes require input from the ACIP for vaccines benefits extended to Veterans, the Medicaid program, the Vaccine for Children’s program, as well as other coverage such as the Affordable Care Act.

At question were:

• a May 27, 2025 order that the CDC stop recommending pregnant women and “healthy” children receive the COVID-19 vaccine. There was no dispute that ACIP was not consulted in this change to the vaccine schedule.
• The reconstitution of the ACIP when on June 9, 2025, Secretary Kennedy terminated all 17 members of the ACIP and the appointed new members on June 11, 2025, September 11, 2025, and January 13, 2026 who did not go through the historical vetting and review process.
• Three votes by the newly constituted ACIP that made official vaccine change recommendations. (discontinuance of thimerosal in the production of influenza vaccines, the change of COVID vaccination recommendations for adults and children from routine to shared clinical decision making, and a change to the universal hepatitis B birth dose)
• A January 5, 2026 HHS memo from Director O’Neill revising the childhood immunization schedule reducing the number of recommended vaccines from 17 to 11 without consideration or recommendation from ACIP.

One thing that may have helped the judge in this case find for the plaintiffs is that the counsel for the defendants seemed to carry their arguments so far as to be absurd. First, they argued that the Secretary has such broad authority that he could withdraw all immunization schedules and recommendations if he wished. That is counter to the charter for the CDC and seems inconsistent with the law on the scope of permissible delegated authority by the executive branch pursuant to Congressional statute.

Second, in an exchange with the Court:

Court: “Let’s say that instead of revising the vaccine schedule the CDC said, actually, we think measles is good for you; you should go have lunch with someone with measles, and we are sponsoring measles lunches in every city, come have some measles lunch, that would seem to — that would seem to go right up against the goal of preventing communicable diseases. Would such a policy by the CDC be judicially reviewable?

Defense Counsel: I think that would still be committed to agency discretion by law.

Court: 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: No.

Well, in my opinion, the defense was not well served by this counsel because when you answer questions like that, you are just going to lose credibility with the judge and then you lose your effectiveness in advocating for your client. Seems almost a rookie mistake.

Statute provides that the CDC’s purpose is “the prevention and suppression of communicable diseases.”

With respect to the May 2025 memorandum, the Court found that it was rendered moot (no longer an issue to be decided) because subsequent actions no longer made it relevant.

However, the Court found that the January 2026 memorandum was issued without the input of the ACIP and without a reasonable justification for ACIP not being involved. Thus, it was arbitrary and capricious and in violation of the APA. The Court ordered it stayed (given no effect; halted; and of no force).

The FACA was enacted, in part, to ensure that persons or groups directly affected by a particular advisory committee would have some representation on the committee, as well as to ensure greater transparency of the work of such committees.

The Court also noted that advisory committee members are to include those with demonstrated professional or personal qualifications and experience that are relevant to the functions and tasks to be performed by the committee. The Court noted that of the current 15 members, under the most generous reading, only six could arguably be said to have meaningful experience and expertise in the area of vaccines and vaccinology – the exact focus of ACIP.

Further, the lack of formality and process in selecting and appointing these members violated historical practice, but was also inconsistent with internal CDC policies and procedures. What typically had been a couple year process was reduced to less than four months. The process failed to issue notice in the Federal Register and ignored the normal year-round online application process. The process also lacked transparency.

The Court concluded that the plaintiffs were likely to prevail on their challenge to the newly constituted ACIP and thus stayed the appointments of thirteen of the 15 members at issue in the motion. For similar reasons, the Court stayed all three of the decisions made by the newly reconstituted ACIP at issue.