The U.S. Department of Health and Human Services (HHS) is looking for public comment on the federal vaccine recommendations. This comes on the tail of the announcement on August 10, 2026 from the White House of the new “Gold Standard Childhood Vaccine Recommendations” in an executive order. (Read the SHF analysis here!)
In the executive order, the president asked the revived “Task Force on Safer Childhood Vaccines” to issue a report regarding “timing and sequencing” of the schedule, alternatives to adjuvants like aluminum, how industry can separate combo shots into singles, and a plan to increase safety monitoring and research on risks and benefits of vaccines.
The request for comments has a large focus on the new category of “Shared Clinical Decision-Making” (SCDM), and how that label affects people’s informed consent. However, the department wants input on many more things including on what evidence basis the government should make recommendations, and what to do when evidence is uncertain.
The comment request stresses the White House position that public health should rely on trust, and not on mandates. One of the questions HHS has for the public is what effects “mandates and other compulsory or high-pressure approaches” have on public trust.
“A substantial body of research indicates that top-down mandates and coercive measures can sow distrust and provoke psychological reactance, particularly among persons whose trust in government is already low.”
The request also reflects a strong Constitutional understanding that public health is the domain of the states, not the federal government.
“In the United States, vaccination requirements have historically been creatures of State law within constitutional limits, and Federal recommendations are recommendations, not mandates. The Department believes that distinction should be preserved and made legible to the public.”
HHS has 18 specific questions for the public, which are listed below, directly from the Federal Register notice.
SHF cannot provide a script because duplicate comments will be ignored. We can provide some of our thoughts and talking points to get you started though!
In short, this is an historic opportunity to take a swing at mandates. SHF holds the position that is now being echoed in the White House – mandates are bad policy. HHS was correct to say that vaccine decisions belong in the states, and this open comment period gives us all a chance to put that on a public record.
We also have the opportunity to stand up for informed consent in a real way. The bulk of this comment request is focused on recommendations for “Shared Clinical Decision-Making,” which, in plain terms, means: talk to your doctor about whether this pharmaceutical product is right for your kid. We could call it the “informed consent category.”
Questions from HHS to the public:
Commenters need not address every question. Supporting data, citations, and concrete examples are encouraged.
A. Adequacy of the Current Categories
1. Are the current categories (routine, risk-based, and shared clinical decision-making/individual-based decision-making) adequate, clear, and well understood by clinicians, patients, and parents? What evidence bears on how each category is understood in practice?
2. Do the current categories convey meaningful differences in the strength of the evidence, the magnitude of individual and population benefit, and the room left for individual circumstances and values? If not, how should those differences be conveyed?
3. Do the current categories unintentionally imply that parental permission, individual consent, or meaningful clinical discussion applies only to shared clinical decision-making recommendations? Should the framework expressly distinguish the strength of a Federal recommendation from the consent, parental-permission, and assent processes involved in administering a vaccine?
B. Potential Additional or Modified Categories and Timing and Frequency Recommendations
4. Should additional or different categories be adopted, such as “recommended, but not during infancy” (or otherwise age-de-emphasized recommendations); “recommended with qualification”; or “shared clinical decision-making with qualification”? For any proposed category, describe its definition, its default (if any), its evidentiary basis, and its intended downstream consequences.
5. What can be learned from the recommendation structures of peer bodies abroad, such as global or international health bodies of peer regulatory bodies?
6. If new categories were adopted, what is needed to preserve access to vaccines currently available to Americans and ensure predictable and consistent treatment under coverage requirements, program eligibility rules, the injury-compensation programs, and State law?
7. If categories remain the same, what modifications to timing and frequency of vaccine administration (for example, clearer presentation of flexible age ranges such as the 12-through-15-month window for the first dose of measles-containing vaccine) or guidance on administering vaccines individually versus at a single visit would help parents and clinicians understand that a vaccine is recommended while affording flexibility in timing of administration?
C. Shared Clinical Decision-Making: Meaning, Risks, and Benefits
8. What does, or what should, “shared clinical decision-making” mean in the vaccination context? How, if at all, does “individual-based decision-making” differ?
9. Does the term “shared clinical decision-making” create an unintended contrast with routine recommendations? Since shared decision-making describes a clinical process applicable to all vaccine decisions, should the Department reserve that phrase for use across all categories and instead adopt “conditional recommendation” or “recommendation based on individualized assessment” for recommendations whose expected benefit varies materially among individuals?
10. What are the benefits of an SCDM category, including respect for autonomy, informed consent, religious conviction, and individualized clinical judgment, and what evidence supports them?
11. What are the risks of an SCDM category, including confusion, reduced access or uptake, and time burdens in practice, and what evidence supports them?
12. An SCDM recommendation, once adopted by the CDC Director, triggers the same coverage requirements as a routine recommendation, including coverage without cost-sharing under the Affordable Care Act and availability through the Vaccines for Children program. Given evidence that patients and even providers may not understand this, what steps should the Department take to educate the public and the provider community that SCDM-recommended vaccines are covered? What communication formats would most effectively ensure that an SCDM designation is not misread as a lapse in coverage or a signal that a vaccine is unavailable?
13. What supports would make SCDM work as intended, such as decision aids, provider training, documentation standards, coverage clarifications, or category-specific communication materials, and who should develop them?
D. Considerations in Setting Recommendations
14. What considerations should be relied upon in establishing vaccine recommendations and assigning categories, and under what conditions should each predominate? Commenters are specifically invited to address the availability, quality, and strength of evidence; the appropriate approach where randomized controlled trial evidence is absent, infeasible, or unethical to obtain; disease severity and epidemiology; individual versus population benefit; a presumption in favor of individual autonomy, informed consent, and religious freedom; and feasibility and programmatic consequences.
15. When evidence is limited, uncertain, or evolving, how should that uncertainty be reflected in the recommendation itself, whether through category assignment, qualifying language, sunset or re-review provisions, or explicit statements of evidentiary certainty, rather than resolved silently in favor of either a universal recommendation or no recommendation?
E. Trust and Communication
16. What does the evidence show about the effects of mandates and other compulsory or high-pressure approaches on public trust, vaccine confidence, and long-run vaccination behavior? How should Federal recommendation policy account for those effects, consistent with the principle that Federal recommendations are not mandates?
17. What communication practices should accompany vaccine recommendations so that they earn and keep public trust, and what lessons from COVID-19-era communication should inform them?
18. How should the Department measure whether a recommendation framework is succeeding, and what data should be collected and published for that purpose?