Uncertainty Looms Over Pharma's Legal Strategy as States Challenge New Vaccine Schedule

15 Democrat-led states sued HHS Secretary Robert F. Kennedy Jr., CDC Director Jay Bhattacharya, CDC, and HHS over the January 2026 CDC decision reducing the childhood immunization schedule from 17 to 11 diseases, removing vaccines for rotavirus, meningococcal disease, hepatitis A, hepatitis B, influenza, COVID-19, and RSV.235

The lawsuit alleges the changes bypassed federal law, ignored scientific evidence, involved unlawful ACIP overhaul by firing and replacing members with vaccine skeptics, and risk public health by increasing vaccine-preventable diseases.235

Vaccine manufacturers like Pfizer, Moderna, Merck, GSK, and Sanofi face potential sales losses (e.g., Merck’s Gardasil), but legal expert Dorit Reiss predicts they will likely not file amicus briefs due to unpopularity, staying on the sidelines.2

This follows a 2025 AAP lawsuit over COVID-19 vaccine removal from schedules for healthy children and pregnant women, now expanded to challenge the new schedule and ACIP changes.26

The new ACIP meeting was delayed from this week to March 18 after missing a legal notice deadline, adding to confusion.3

Changes may impact vaccine makers' liability protections under the 1986 National Vaccine Injury Compensation Program.4

Sources:

2. https://www.biospace.com/policy/uncertainty-looms-over-pharmas-legal-strategy-as-states-challenge-new-vaccine-schedule

3. https://www.biopharmadive.com/news/15-states-sue-hhs-vaccine-schedule-changes-acip/813026/

4. https://www.statnews.com/2026/01/08/vaccine-schedule-changes-raise-lawsuit-risks-manufacturers/

5. https://www.ag.state.mn.us/Office/Communications/2026/02/25_VaccineSchedule.asp

6. https://www.cidrap.umn.edu/childhood-vaccines/state-us-vaccine-policy-feb-19-2026