Bass, Berry & Sims attorneys Clint Hermes and Heather Pearson authored an article for the American Health Law Association (AHLA) outlining changes to the annual immunization schedules for children and pregnant women recently issued by the Centers for Disease Control and Prevention (CDC). Following the CDC’s issued guidance, the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) issued competing vaccine schedules for children and pregnant women, respectively. As the authors note, “While immunization schedules, whether issued by the CDC or by a professional medical organization, function as guidelines, the CDC’s changes have downstream implications for health care providers to consider, including those related to insurance coverage, access, and liability. The Food and Drug Administration’s (FDA’s) further updates to the COVID-19 vaccine approvals add additional complexity to this rapidly evolving space.”
The CDC’s Advisory Committee on Immunization Practices (ACIP) is tasked with establishing, reviewing, and revising vaccine schedules. These schedules provide recommendations about what vaccines to give, when, and to whom. However, in late May, Department of Health and Human Services (HHS) Secretary Kennedy announced a revised immunization schedule without input from ACIP. The ACIP subsequently updated its recommendations, including those for influenza and COVID-19; specifically, the ACIP recommended limiting influenza vaccination to only those vaccines without the preservative thimerosal and requiring COVID-19 vaccines to be made pursuant to “shared clinical decision making.” Heather and Clint explain how these updated recommendations, coupled with the FDA’s narrowed approval of the 2025-2026 COVID-19 vaccine formulation, “marks a notable public health fissure with implications in state and federal law with downstream consequences.”
The authors also explore the additional changes impacted by the latest updates, including: (1) who is authorized to administer the vaccines, (2) how insurance coverage and program access may change, and (3) what liability protections may no longer apply.
The full article, “Shifting Schedules: Unpacking the Competing 2025 Vaccine Schedule Changes,” was published by the AHLA’s Physician Organizations Practice Group on September 25 and is available online (subscription required).