Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: HHS seeks input on future of vaccine guidance, (Aug 27, 2026)

By Patricia K. Ruiz, J.D.

The request seeks feedback on evidentiary standards, legal consequences, coverage issues and communication practices tied to federal immunization guidance.

HHS has launched a request for information seeking public input on whether the categories used in federal vaccine recommendations remain adequate and whether additional recommendation classifications should be adopted. The initiative asks stakeholders to weigh in on the role of shared clinical decision-making, the evidentiary standards that should inform vaccine recommendations, and the legal and programmatic effects that flow from category designations. The agency said the comments will help inform work by the Task Force on Safer Childhood Vaccines and implementation of an executive order on childhood vaccine recommendations (Notice, 91 Fed. Reg. 54724 (Aug. 24, 2026)).

Request for information issued. HHS seeks public input on the three categories currently used in federal vaccine recommendations: routine (universal), risk-based, and shared clinical decision-making, which the agency also describes as individual-based decision-making. The department is asking whether those categories are clear, well understood and sufficient, and whether additional or different categories should be adopted. The request for information was published by the Office of the Secretary on Aug. 24. Comments are due by Sept. 20, 2026.

Focus on recommendation categories. According to the notice, federal vaccine recommendations are developed principally through the Centers for Disease Control and Prevention and its Advisory Committee on Immunization Practices. Under the current framework, routine recommendations generally apply to all persons in an age group absent contraindications, risk-based recommendations apply to specified risk groups, and shared clinical decision-making recommendations are based on individualized discussions between healthcare providers and patients or parents and guardians.

HHS asked commenters whether the existing categories meaningfully convey differences in the strength of evidence, the magnitude of individual and population benefit, and the degree to which individual circumstances and values should influence vaccination decisions. It also asked whether the current framework could create confusion regarding consent, parental permission or clinical discussions associated with vaccine administration.

Potential new classifications under review. The notice specifically invites comment on whether new recommendation categories should be created, including concepts such as "recommended, but not during infancy," "recommended with qualification," or "shared clinical decision-making with qualification." The agency requested feedback on how any new category should be defined, what evidentiary standards should support it, and what downstream consequences it could have.

HHS further asked stakeholders how any revised framework could preserve access to vaccines and ensure consistent treatment under coverage requirements, eligibility rules, vaccine injury compensation programs and state laws.

Shared clinical decision-making examined. A substantial portion of the request focuses on shared clinical decision-making. The department noted that the category replaced the earlier "Category A" and "Category B" framework in 2019 and stated that experience with the approach has produced both criticism and support.

HHS cited concerns that shared clinical decision-making recommendations may require additional time, create confusion regarding coverage and implementation, and be displayed inconsistently in health information systems. At the same time, the notice said some clinicians and commenters view the category as an appropriate patient-centered approach when the balance of benefits and risks varies across individuals or when evidence is limited or evolving.

Among other issues, HHS asked whether the term "shared clinical decision-making" should be replaced with alternative terminology, what benefits and risks are associated with the category, and what tools or support systems could improve its use in practice.

Legal and policy considerations highlighted. The request seeks comment on factors that should guide vaccine recommendations and category assignments. HHS identified potential considerations including the availability and strength of scientific evidence, approaches for situations in which randomized controlled trial evidence is unavailable, disease severity, individual versus population benefits, informed consent, individual autonomy, religious freedom, feasibility and programmatic consequences.

HHS also requested information on how uncertainty should be reflected in recommendations when evidence is limited, uncertain or evolving, including through category assignments, qualifying language, re-review provisions or explicit statements regarding evidentiary certainty.

Public trust and communication questions. The notice devotes a separate section to public trust and communication practices. HHS said it is interested in comments concerning the effects of mandates and other compulsory approaches on trust, vaccine confidence and vaccination behavior, and how federal recommendation policy should account for those considerations while maintaining the distinction between recommendations and mandates. HHS seeks information on communication practices that should accompany vaccine recommendations, what lessons should be drawn from COVID-19-era communications, and how the success of a recommendation framework should be measured.

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