The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
As 15 states sue the Department of Health and Human Services over changes to the childhood immunization schedule, it remains unclear whether manufacturers with sales threatened by the update will lend their voice to the legal challenge or stay on the sidelines.
Vaccine makers that could be affected include Pfizer, Moderna, Merck, GSK, Sanofi and others.
Dorit Reiss, professor of law at UC Law San Francisco, noted in an email to BioSpace that manufacturers have not filed amicus briefs in support of the case the American Academy of Pediatrics (AAP) brought last year against HHS, Robert F. Kennedy Jr. and other people and organizations behind earlier changes to the recommended immunization schedules for children and pregnant women.
The AAP case focuses on the May 2025 decision to remove COVID-19 vaccines from the list of products recommended for healthy children and pregnant women. Last week, 15 states led by Democrats brought a new case against the HHS, Kennedy and others. That case challenges the CDC’s recent decision to reduce the routine childhood and adolescent immunization schedule from targeting 17 diseases to 11.
Some vaccine manufacturers have expressed concerns about the changes. Thomas Triomphe, Sanofi’s executive vice president of vaccines, said on an earnings call in January that the “sudden shift” to the new schedule will create confusion for parents and healthcare providers. Guggenheim Securities analysts cut their estimates for U.S. sales of Merck’s Gardasil in 2026 and beyond in response to the changes.
The potential for the revised immunization schedule to cut sales creates an incentive for companies to support the states’ challenge by filing amicus briefs. Yet Reiss said pharma companies “may reasonably think it’s better to stay away, given their lack of popularity.” While noting that she has no inside information, the professor said that she would guess manufacturers will opt against filing amicus briefs.
Reiss expects the public health organizations that filed briefs for the AAP case to submit amici in support of the 15 states’ case against the HHS and RFK Jr. The AAP case docket includes eight amicus filings signed by more than 100 public health experts and organizations such as the American Association of Immunologists, the American College of Obstetricians & Gynecologists and Defend Public Health.
The 15 states’ case covers the COVID-19 vaccine change made last May, which the CDC incorporated into the updated immunization schedule in January. In their lawsuit, the states called the new schedule the “culmination of a series of unlawful actions in furtherance of Secretary Kennedy’s idiosyncratic and unscientific hostility to vaccines.”
The states seek to get the schedule and changes to the membership of the Advisory Committee on Immunization Practices (ACIP) declared unlawful. The states claim appointing “unqualified ACIP members” and bypassing the committee to create the new immunization schedule were “arbitrary and capricious and contrary to law.”
