The Department of Health and Human Services (HHS) issued a Request for Information on Friday seeking public comment on federal vaccine categories. The administration is considering changes or additions to these classifications to support an executive order issued by President Trump earlier this month.
Current federal guidelines categorize vaccines as routine (universal), risk-based, or shared clinical decision-making (SCDM). The SCDM category, adopted in 2019, applies to vaccines that a provider and patient discuss to determine if the benefits apply to that specific individual. The administration is now asking the public to weigh in on whether these existing categories remain adequate.
In a recent executive order, President Trump called for moving several childhood vaccines from the universal category to either the risk-based or SCDM categories. This change would reduce the number of routine immunizations from 18 to 11. The HHS document asks if additional or different categories should be adopted by the federal government.
For families, this shift would likely change the day-to-day experience of pediatric visits, as doctors and parents would need to engage in more extensive consultations to determine which of the seven reclassified vaccines a child should receive. Healthcare attorney Richard Hughes IV noted in a memo that the RFI does not mention the Advisory Committee on Immunization Practices (ACIP), a body that has developed recommendations since 1964. Because ACIP recommendations serve as the legal trigger for various federal and state programs, a change in categories could impact insurance coverage mandates under the Affordable Care Act and zero-cost-sharing under Medicare Part D.
The reclassification could also influence the scope of the Vaccines for Children (VFC) program and pharmacist practice authorities across dozens of states that rely on federal routine schedules. A person would notice these changes in the form of updated requirements for school enrollment or changes in what their insurance provider is legally required to cover without a co-pay. The public has until September 20, 2026, to submit comments on the proposed changes before the administration moves toward a final decision.
The HHS Request for Information (RFI) follows the president's executive order from earlier this month. The public comment period is scheduled to remain open until September 20, 2026. Health care attorney Richard Hughes IV stated in a memo that the administration is making clear its intent to modify existing recommendation categories under the guise of requesting information.