Judge Pauses Overhaul of Vaccine Committee and Recommendations

In May 2025, Secretary of the Department of Health and Human Services (HHS) Robert F. Kennedy Jr. ordered the Centers for Disease Control (CDC) to stop recommending that pregnant women and “healthy” children receive the COVID vaccine. The following month, Secretary Kennedy terminated the appointments of all 17 members of the Advisory Committee on Immunization Practices (ACIP) – a historically non-partisan committee tasked with proffering expert guidance and recommendations regarding CDC vaccine guidelines and schedules – and subsequently appointed new ACIP members.

Under new appointees and through the end of 2025, ACIP overhauled several longstanding recommendations including recommending against the combined measles, mumps, rubella, and varicella (MMRV) shot and revising from “routine” to “shared clinical decision making” for COVID-19 vaccines and newborns to receive a vaccine against hepatitis B.

In January 2026, without consulting ACIP, HHS published a new CDC Childhood Immunization Schedule, moving several recommendations from “routine” to “shared clinical decision making” and/or recommended for “certain high-risk groups or populations.” The cumulative effect of these massive changes created uncertainty regarding payer coverage, liability exposure for providers and manufacturers, and other downstream impacts to various laws, regulations, and policies that have been tied to CDC vaccine recommendations developed by ACIP.

The changes were challenged in the U.S. District Court of Massachusetts, beginning in July 2025, by a coalition of legal medical professional societies including the American Academy of Pediatrics.

After combing through the various changes to the CDC vaccination schedules and the reconstitution of ACIP, on March 16, 2026, the court issued a memorandum and order determining that the plaintiffs demonstrated that the appointments to ACIP as well as the changes to vaccine recommendations would result in an “irreparable injury” as a likely violation of the Administrative Procedures Act (APA), including a violation of Federal Advisory Committee Act (FACA) related to the appointment of the new ACIP committee members. As a result, the court granted a stay with respect to (a) the appointment and participation of 13 of the panel’s members, (b) any actions ACIP took with the new members, and (c) the CDC’s childhood immunization schedule from January 2026.

In practical terms, this means stakeholders return to the status quo from before those actions were taken while the case continues. Most tangibly, this means CDC vaccine recommendations that were changed from “routine” to “shared clinical decision making” return to “routine.”

In the context of the broader legal landscape, many of the recent administrative actions by federal agencies are being invalidated in the courts. The government has been unable to provide sufficient administrative records in support of a number of agency decisions across many agencies. In many cases, they can go back and re-do the action more deliberately, building out a stronger administrative record.

Here, however, beyond the procedural deficits, the judge pointed substantively to the statutory authority of HHS to “assist States and their political subdivisions in the prevention and suppression of communicable diseases” and “advise the several States on matters relating to the preservation and improvement of the public health”¹ . With respect to vaccines specifically, HHS is tasked with funding “a national, evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases, combat misinformation about vaccines, and disseminate scientific and evidence-based vaccine-related information, with the goal of increasing rates of vaccination across all ages, as applicable, particularly in communities with low rates of vaccination, to reduce and eliminate vaccine-preventable diseases.”².

With this additional emphasis by the court, even if HHS goes back and follows appropriate processes, building a proper administrative record, if new recommendations continue to run counter to the statutory goal of increasing rates of vaccination and the commitment to preventing and suppressing communicable diseases, this memorandum and order may support additional challenges.

This blog was drafted by Spencer Fane health care attorneys Beth Siemer and Jeramy Ashton, attorneys in St. Louis, Missouri, and Salt Lake City, Utah, offices of Spencer Fane, respectively. For more information, visit spencerfane.com.

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¹_{42 U.S.C. § 243(a)}

²_{42 U.S.C. § 245(a)}