The Department of Health and Human Services (HHS) opened a public consultation on whether the three categories used in federal vaccine recommendations should be revised or expanded. The agency is seeking comment on the existing routine, risk-based, and shared clinical decision-making (SCDM) categories, including whether additional tiers should be created to better reflect differences in evidence and individual benefit-risk considerations.
The Request for Information (RFI) follows an August 10 executive order directing HHS Secretary Robert F. Kennedy Jr., working through the Task Force on Safer Childhood Vaccines, to present plans within 90 days addressing the timing and sequencing of the federal childhood immunization schedule and continuous evaluation of the benefit-risk profile of recommended vaccines. HHS said responses to the RFI will inform that work.
HHS is explicitly seeking views on potential recommendation categories including "recommended, but not during infancy," "recommended with qualification," and "SCDM with qualification." The agency asks whether the current framework adequately communicates differences in the strength of supporting evidence, magnitude of individual and population benefit, and circumstances in which vaccination decisions should depend more heavily on individual factors.
The RFI also focuses on SCDM, under which there is no default recommendation to vaccinate and the decision is made between a healthcare provider and patient or parent. HHS cites survey data showing that approximately 90%–95% of physicians found SCDM recommendations more time-consuming to implement than routine recommendations, while fewer than half knew that vaccines recommended under SCDM remain covered by insurance. Most respondents also reported that the category created confusion for patients.
Evidence standards are another focus. HHS asks how recommendations should be made when randomized controlled trial evidence is limited or absent, whether uncertainty should be communicated through qualifying language or time-limited recommendations, and whether the certainty of evidence under the GRADE framework should be displayed more explicitly. The agency is also seeking comment on how scientific evidence should be weighed alongside individual autonomy, informed consent, feasibility, and population-level considerations.