Background on changing vaccine policy

Vaccine policies governed by a range of regulatory agencies have been changing.

The Food and Drug Administration (FDA) is charged with regulating what drugs, including vaccines, can be marketed and sold in the U.S. In late August, the FDA narrowed its recommended uses for the COVID-19 vaccine, indicating it was recommended for all individuals over 65 as well as for those six months to age 65 with high risk of severe outcomes, based on underlying health conditions. However, “high risk” is a broadly defined term. Many adults might possess underlying conditions. Although this change initially generated some disruption in access to the vaccine, the disruption was alleviated through adjustments in state and pharmacy distribution policies and practices.

The Advisory Committee on Immunization Policies (ACIP) is tasked with making recommendations to the Centers for Disease Control and Prevention (CDC) regarding vaccine usages for purposes of the U.S. immunization schedule for adults, adolescents and children. The recommendations and schedule become official policy once adopted by the director of the CDC. The ACIP recommendations are also referenced in the ACA as one body of recommendations that govern what vaccines must be covered by non-grandfathered group health plans without cost sharing, as recommended preventive services.

Significant restructuring of the ACIP committee began in June when 17 committee members appointed by President Biden were removed and some were replaced by Secretary of Health and Human Services Robert F. Kennedy, Jr. While this sparked Congressional oversight, the newly structured ACIP Committee proceeded with issuing new recommendations. Most notably, on September 19, 2025, the ACIP Committee issued recommendations that emphasize individual decision-making. The recommendation applies to individuals who are six months and older and appears on the vaccination schedules as, “vaccination based on shared clinical decision-making,” which references providers including physicians, nurses and pharmacists. The ACIP Committee did not recommend that prescriptions be required for COVID-19 vaccines.

The recommendations included other changes unrelated to the COVID-19 vaccine. The Committee recommended that all pregnant women be tested for Hepatitis B and that the Varicella (chickenpox) vaccine should be provided as a standalone vaccine separate from measles, mumps and rubella. On October 6, 2025, the CDC Director adopted the ACIP vaccine recommendations, incorporating them into the U.S. vaccination schedule and making them official.

The changes are aimed at emphasizing a shared decision-making process, where individuals can consult with a clinician and consider the benefits and risks of the vaccine along with the specific characteristics of their personal health. If, after clinical decision-making, a determination is made that the vaccine is appropriate, it should be covered as a recommended preventive service under the ACA, without cost sharing or a prescription. Vaccines should be available in doctors’ offices and pharmacies, as they have in prior years.

Implications for individuals and plan sponsors

Generally, individuals who would like to receive the vaccine will be eligible to receive it.

While it seems that most plan documents will not require any revisions, plans should review their terms related to the COVID-19 vaccine to ensure they do not include any wording that might require modification.

Through this plan year, plans must continue to cover the COVID-19 vaccine for all individuals over six months of age, irrespective of shared clinical decision-making.