Secretary Kennedy asked for comment on how to revise the CDC vaccine schedule. Here is what we submitted on behalf of @ICANdecide on that score: I. Every Vaccination Recommendation and Decision Should be Based on Shared Clinical Decision-Making (SCDM) The central principle is straightforward: vaccines should be treated like every other medical intervention administered to an individual patient. The appropriate approach, therefore, is SCDM, where there is no “default” decision to vaccinate, but where “the decision about whether or not to vaccinate may be informed by the best available evidence of who may benefit from vaccination; the individual’s characteristics, values, and preferences; the health care provider’s clinical discretion; and the characteristics of the vaccine being considered” with no “prescribed set of considerations or decision points in the decision-making process.”[1] This process should apply to every vaccine—period. HHS should therefore not treat SCDM as a special category reserved for a subset of vaccines or classes of vaccines; it is the appropriate clinical process for every vaccine decision. We urge HHS to adopt and implement this principle across the entire federal vaccine recommendation framework. A. Ethics and Informed Consent Demand SCDM The RFI states that personal autonomy, informed consent, and the values and preferences of patients and parents “apply across all vaccine recommendations, including routine ones.” However, with the current categories, most of which are “default” decisions to vaccinate, that statement has no practical effect. A federal recommendation should not predetermine the medical decision of any particular patient. This principle is consistent with ordinary clinical practice and ethics. The Agency for Healthcare Research and Quality (“AHRQ”) describes SCDM as a collaborative process in which patients and clinicians make healthcare decisions informed by evidence, clinical expertise, and the patient’s values, goals, and circumstances.[2] The American Medical Association likewise recognizes informed consent as fundamental to medical ethics.[3] The fact that a vaccine is recommended by public health authorities does not eliminate the need for individualized clinical assessment or informed consent. Each patient’s medical history, risk factors, prior reactions, values, and preferences may affect the appropriate decision in ways a population-level recommendation cannot capture.[4] The current federal framework classifies a majority of vaccine recommendations as a “default” decision to vaccinate. Other medical frameworks reject this approach: Clinical Practice Guidelines, for example, are designed to inform clinician-patient decision-making by presenting the evidence and the likely benefits and harms of available options, without dictating a one-size-fits-all course of care.[5] There should not be any “routine” or “risk-based” recommendations. Population-level criteria cannot capture every clinically relevant characteristic of each patient, and applying them directly to individual decisions risks creating the false impression that harm-benefit tradeoffs are uniform across everyone who meets a given classification. In reality, individuals within the same risk group often differ substantially in their risk for the relevant outcome and in the balance of benefits and harms of treatment. Population-level classifications should never substitute for the individualized evaluation of all relevant patient attributes that determines whether an intervention offers a true net benefit to a specific patient.[6] A clinician should never administer a vaccine based on a government recommendation but rather should only administer every vaccine based on SCDM which allows for informed consent and an evaluation of each individual’s medical history, competing risks, and personal values. B. Many Childhood Vaccines Do Not Prevent Infection or Transmission and/or Have Limited or Uncertain Community-level Impact While all vaccines should be administered based on SCDM, without any exception, CDC’s existing guidelines already provide that most vaccines should be SCDM because they do not meaningfully prevent transmission. As CDC’s guidance provides: “ACIP makes shared clinical decision-making recommendations when individuals may benefit from vaccination, but broad vaccination of people in that group is unlikely to have population-level impacts.” For example, DTaP, Tdap, IPV, and MenACWY do not meaningfully prevent transmission, as detailed in the following link with supporting citations: sirillp.com/wp-content/uploa…. Also see an FDA Briefing Document, dated September 20, 2024, titled Use of Controlled Human Infection Models to Support Licensure of Pertussis Vaccines which explains that “aP [acellular pertussis] containing vaccines induce helper T cells (TH2) memory and neutralizing antibody responses that effectively prevent symptomatic disease but fail to prevent colonization and carriage.”[7] In a similar vein, HPV is almost exclusively transmitted through sexual contact, and, in most cases, an 11-year-old is not sexually active and may not face any meaningful near-term exposure risk. The decision to vaccinate at age 11 versus later should therefore be based on individualized considerations—anticipated timing of exposure, medical history, and parental values—rather than a uniform community-wide transmission concern. Hence, even putting the significant risks of this product aside, HPV vaccines should be recommended pursuant to SCDM so that clinicians and parents can evaluate risks, benefits, and timing for the individualized child, rather than applying a one-size-fits-all approach. As a final example, studies reflect that influenza vaccine has not been shown to meaningfully prevent transmission among children[8] and influenza vaccination during pregnancy involves widely varying clinical circumstances and risk profiles, and patients differ in their medical history, prior vaccine reactions, trimester-specific considerations, and personal values. A meaningful recommendation therefore requires an individualized discussion of expected risks and benefits, available alternatives, and the patient’s preferences—not a reflexive “routine” assumption. This approach is consistent with an evidence-based framework that prioritizes informed consent and individualized care, especially where community transmission benefits are not the driving rationale for giving this vaccine during pregnancy. The bottom line is that every vaccine should forthwith be moved to the SCDM category so that they will be administered through counseling based on the individual’s circumstances. HHS should eliminate all categories except for SCDM and treat all vaccines like every other drug or medical procedure. Sources: [1] cdc.gov/acip/vaccine-recomme… [2] About Shared Decision Making, Agency for Healthcare Research and Quality (last visited Aug. 25, 2026), ahrq.gov/sdm/about/index.htm…. [3] Opinion 2.1.1 Informed Consent, American Medical Association Code of Medical Ethics (last visited Sept. 3, 2026), code-medical-ethics.ama-assn…. [4] Anil Makam and Oanh Nguyen, An Evidence-Based Medicine Approach to Antihyperglycemic Therapy in Diabetes Mellitus to Overcome Overtreatment, Circulation (Jan. 10, 2017), ahajournals.org/doi/10.1161/…. [5] Clinical Practice Guidelines We Can Trust, National Academies (2011), nationalacademies.org/read/1…. [6] David Kent, et al., The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement, Annals of Internal Medicine (Nov. 12, 2019), acpjournals.org/doi/10.7326/…. [7] VRBPAC, FDA Briefing, September 20, 2024, fda.gov/media/181937/downloa…. [8] See, e.g., cochranelibrary.com/cdsr/doi…; pmc.ncbi.nlm.nih.gov/article….