Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making

Issuing agencies

Abstract

The Department of Health and Human Services (HHS or the Department), in support of the Task Force on Safer Childhood Vaccines and in furtherance of the Executive Order of August 10, 2026, "Delivering Gold Standard Childhood Vaccine Recommendations for Americans," seeks public comment on whether the categories currently used in Federal vaccine recommendations are adequate. Those categories are routine (universal) recommendations, risk-based recommendations, and recommendations based on shared clinical decision-making, also referred to as individual-based decision-making. The Department seeks comment on these categories and whether additional or different categories should be adopted. The Department further seeks comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence, the appropriate approach when randomized controlled trial evidence is limited or absent, a presumption in favor of individual autonomy and religious freedom, the downstream legal and programmatic consequences of category assignment, and the communication practices necessary to earn and maintain public trust.