On July 7, 2025, a coalition of healthcare organizations – including the American Academy of Pediatrics, American College of Physicians and Infectious Diseases Society of America, along with a pregnant Massachusetts physician – filed suit in the U.S. District Court for the District of Massachusetts against U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. in response to his directive to change U.S. vaccination policy. Specifically, Secretary Kennedy directs the removal of healthy children and healthy pregnant women from COVID-19 vaccine recommendations.
The plaintiffs also object to the wholesale dismissal of the Centers for Disease Control and Prevention's (CDC) 17-member Advisory Committee on Immunization Practices (ACIP), alleging the terminated ACIP members were replaced by individuals lacking vaccine, infectious disease or immunology expertise – almost all of whom, it is further alleged, espouse vaccine skepticism. (See Complaint at paragraphs 72-74, Am. Acad. of Physicians v. Kennedy, Case No. 1:25-cv-11916 (D. Mass. July 7, 2025) arguing that Secretary Kennedy "stacked the ACIP with unqualified members with histories of taking anti-vaccine positions," none of whom "follow[ed] the rigorous application process to become an ACIP member.")
The plaintiffs seek to enjoin Secretary Kennedy's directive and obtain a declaratory judgment finding the changes unlawful. Specifically, the plaintiffs argue that the directive constitutes a final agency action subject to the Administrative Procedure Act (APA) and, therefore, that the required procedures to promulgate the directive under the APA were not followed. The plaintiffs also argue that the directive is arbitrary and capricious and that it will cause them irreparable harm by requiring physicians to ignore a science-backed standard of care vaccination recommendations and instead follow recommendations they believe have been promulgated without any supporting scientific data.
The Complaint details at length the evolution of federal vaccine policy and ACIP's decades-long role in providing evidence-based recommendations for CDC immunization schedules. The Complaint cites Secretary Kennedy's history of vaccine skepticism, public health risks associated with abandoning an evidence-based approach to vaccines and concern that additional vaccines may be similarly removed from CDC schedules.
We anticipate continued controversy around federal vaccine and other public health policies. Holland & Knight attorneys and policy professionals familiar with the regulatory and political landscape will continue to monitor and report on these developments.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
