Federal District Judge Brian Murphy:
“Science,” like law, “is far from a perfect instrument of knowledge.” Carl Sagan, The Demon-Haunted World: Science as a Candle in the Dark 29 (1997). History is littered with once-universal truths that have since come under scrutiny. Nevertheless, science is still “the best we have.” Id.1
“Procedure is to law what scientific method is to science.” In re Gault, 387 U.S. 1, 21 (1967) (cleaned up). Although sometimes seemingly tedious, “the procedural rules which have been fashioned from the generality of due process are our best instruments for the distillation and evaluation of essential facts from the conflicting welter of data that life and our adversary methods present.” Id.
For our public health, Congress and the Executive have built—over decades—an apparatus that marries the rigors of science with the execution and force of the United States government. One extraordinary product of that apparatus has been the eradication and reduction of certain communicable diseases through the development and use of vaccines. In the words of the Centers for Disease Control and Prevention (“CDC”), “[v]accines are one of the greatest achievements of biomedical science and public health.”2 Since the rise of vaccine development and usage in the early- to mid-1900s, “[t]he United States of America [has been] one of the pioneering nations to conceptualize and implement a robust immunization system that helped the nation tackle major epidemics.”3
Since its founding in 1964, the Advisory Committee on Immunization Practices (“ACIP”) has aided this endeavor by providing expert guidance on the clinical use of vaccines.4 The Department of Health and Humans Services (“HHS”), which indirectly oversees ACIP, formalized ACIP’s non-partisan, science-backed nature through ACIP’s governance documents.5 And Congress has, in turn, recognized the importance and value of having such independent experts involved in setting our national public health agenda by cementing ACIP’s role in the CDC’s issuance of immunization schedules, which—among other things—determines which vaccines are available to patients through insurers and government healthcare programs.6 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. 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. Again, this procedural failure highlights the very reasons why procedures exist and raises a substantial likelihood that the newly appointed ACIP fails to comport with governing law.
Today, faced with Plaintiffs’ motion for preliminary relief, the Court concludes that Plaintiffs are likely to succeed in showing that the reconstitution of ACIP and the January 2026 changes to the childhood immunization schedule violate the Administrative Procedure Act (“APA”). For the reasons stated below, the Court will grant Plaintiffs’ motion in part.
