More specifically, the RFI asks the public to consider whether vaccine recommendations should be made with a “presumption in favor of individual autonomy and religious freedom.” It also seeks input on how to handle recommendations when “randomized controlled trial evidence is absent, infeasible, or unethical to obtain.” This relates to a common attack Kennedy has made against childhood vaccines, in which he claims their safety and efficacy trials are flawed because they didn’t test the vaccines against an inert placebo. Scientific and medical experts have largely dismissed this attack, noting that such trials are unnecessary, in many cases unethical, and in some cases the claim is just false. But it seems Kennedy may use it to justify making vaccine recommendations sound less definitive.
As for what the new recommendation categories might be, the RFI gives special consideration to SCDM, which is currently used rarely. The Meningococcal B Vaccination is one of the few vaccines with an SCDM recommendation. The RFI describes this type of recommendation as an “intermediate category” that “provides no default” choice on a vaccination, avoiding a “binary choice between a universal recommendation and no recommendation at all.”
“This allows for an additional opportunity between patient and provider to discuss the state of the evidence and gives weight to the values and preferences of patients and parents/guardians, including considerations of personal autonomy, informed consent, and religious conviction,” the RFI reads. But it also notes that SCDM, when used, has raised confusion. The RFI asks the public to weigh in on potential future use.
Otherwise, the RFI asks for other category options, providing a few ideas, including “recommended, but not during infancy,” “recommended with qualification,” or “shared clinical decision-making with qualification.” The document does not elaborate on what any of those categories might mean.