WASHINGTON (February 10, 2026) — A brief filed in U.S. district court by administrative law and public health scholars in American Academy of Pediatrics et al. v. Kennedy delivers a stark warning. The scholars - experts in how administrative law governs public health decision-making - chronicle how the U.S. Department of Health and Human Services over the last year has rolled back the routine use of multiple vaccines, despite clear and compelling evidence that they are safe, effective, and critical to preventing serious illness and death. In taking these actions, HHS violated laws that govern how major changes to vaccine policy must be made.
Defendants’ actions include the following:
- Downgrading the COVID-19 vaccine from “routine” for all individuals six months and older.
- Dropping a longstanding recommendation for universal hepatitis B vaccination for newborns
- Reducing the number of childhood vaccines recommended for routine use from 17 to 11, affecting vaccines for rotavirus, COVID-19, influenza, hepatitis A, hepatitis B, and meningococcal disease
In place of routine recommendations for vaccination, HHS has shifted multiple vaccines to a category known as “shared clinical decisionmaking,” which was developed for situations where the evidence is unclear on risk and benefits and CDC is unable to find that vaccination would benefit individuals and society. This shift is confusing families and clinicians and is complicating state vaccination policy and practice.
In taking these major actions, HHS bypassed the longstanding legal framework governing the development of the Nation’s vaccine policy. That framework requires evidence development, opportunities for public comment, and the public formulation of recommendations by a legitimately constituted Advisory Committee on Immunization Practices (ACIP). That process did not happen. Nor did defendants comply with public notice and comment procedures that otherwise apply to federal agencies, including HHS, under the Administrative Procedure Act (APA).
Joshua Sharfstein, former acting commissioner and principal deputy commissioner of the U.S. Food and Drug Administration and one of the amici, said, “The law simply does not permit HHS to change vaccine recommendations for millions of American families on a dime. Thorough consideration of evidence, input from leaders in pediatrics and infectious disease, and public discussion are especially important when the lives and well-being of children are at stake.”
Professor Sara Rosenbaum, another member of the amici and an emerita professor of health law and policy at the George Washington University’s Milken Institute School of Public Health and a former member of ACIP, added: “Federal law is clear: changes to vaccine access and use simply cannot happen without extensive evidentiary development and public transparency. These changes have happened completely outside this process through a process that is the opposite of transparent.”
Vaccines have had a profound positive impact on public health, dramatically reducing the risks of serious complications and death. Between 1994 and 2023, vaccinations for U.S. children designated as routine prevented an estimated 508 million illnesses, 32 million hospitalizations, and over 1.1 million deaths.
The brief can be found here.
Amici are represented by Andrew Pincus, Allison Aviki, Graham White, Natasha Harnwell-Davis, and Crystal Paulino, lawyers at Mayor Brown LLP.
The views presented in the brief represent those of the amici and do not necessarily reflect the views of their institutions.
-GW-