The US Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., is exploring significant changes to how vaccine recommendations are categorised and described. The initiative, outlined in a Request for Information (RFI) document, raises the possibility that vaccinations currently regarded as “routine” or “universal” could be reclassified with less definitive or more conditional designations, such as “recommended with qualification” or “recommended based on shared clinical decision-making.”
Mr Kennedy has not yet issued any new rules or specific recommendations for these categories. Instead, he presented a range of ideas and possibilities in the 10-page RFI, which was posted online last Friday and formally published in the Federal Register on Monday. The document invites public input on existing categories and proposals for their modification or replacement, with a deadline for comments set for 20 September.
Currently, vaccine recommendations in the US are granted by the Centers for Disease Control and Prevention (CDC), guided by the Advisory Committee on Immunization Practices (ACIP), a panel of independent expert advisors. These recommendations fall into three established categories: “routine,” often considered universal, implying a recommendation for everyone; “risk-based recommendations,” which apply only to specific groups identified as being at higher risk; and “shared clinical decision-making” (SCDM), a more flexible and less common recommendation based on a patient's characteristics, values, preferences, and the judgment of their healthcare provider.
Before Mr Kennedy's appointment, the CDC and ACIP utilised an evidence-based framework to determine the appropriate recommendation category for each vaccination. Critics argue there is no clear, evidence-based justification for questioning the current categories, nor any scientific data to support the new categorisations Mr Kennedy is proposing. In his RFI, Mr Kennedy prefaces his efforts by referencing an executive order signed by former President Trump a fortnight prior, which aimed to reform federal vaccine recommendations.
This executive order and the new RFI are perceived by some as part of a broader, ongoing campaign by Mr Kennedy and Mr Trump to challenge federal vaccine guidance and perpetuate the claim that vaccines are linked to autism – a claim that has been thoroughly disproven by scientific research.
Mr Kennedy's tenure has already been marked by several controversial actions concerning vaccine policy. He previously attempted to unilaterally reduce the CDC's childhood vaccine recommendations, seeking to align them with those of Denmark. Denmark is described as a relatively small, homogenous country with universal healthcare, which recommends fewer vaccines than other high-income nations. Furthermore, Mr Kennedy dismissed all 17 existing experts on the ACIP panel and appointed new members who are reported to share his anti-vaccine perspectives. Last year, the refashioned panel made several changes to vaccine recommendations that were deemed unwarranted by medical and health experts, including rescinding the universal recommendation for a birth dose of the hepatitis B vaccine.
Many of these previous changes to federal vaccine recommendations and Mr Kennedy's ACIP appointments have been temporarily blocked by a federal judge. The injunction followed a lawsuit initiated by the American Academy of Pediatrics. In March, the judge ruled that Mr Kennedy’s actions regarding vaccine changes and ACIP appointments were likely illegal and had not followed proper administrative procedures. The current RFI appears to be an attempt to comply with administrative procedures, which often involve public comment periods, while also providing further insight into Mr Kennedy's future policy direction.
In an official announcement accompanying the RFI last Friday, Mr Kennedy’s Department of Health and Human Services summarised the initiative as an effort “examining whether the current recommendation framework appropriately reflects the strength of the evidence, accounts for individual circumstances and values, and supports informed discussions among patients, parents, and healthcare providers.”
More specifically, the RFI asks the public to consider whether vaccine recommendations should be made with a “presumption in favour of individual autonomy and religious freedom.” It also seeks input on how to formulate recommendations when “randomized controlled trial evidence is absent, infeasible, or unethical to obtain.” This particular point resonates with a frequent critique Mr Kennedy has made against childhood vaccines, where he asserts that their safety and efficacy trials are flawed due to the absence of inert placebo controls. Scientific and medical experts have largely refuted this criticism, stating that such trials are often unnecessary, in many cases unethical, and that the claim itself is sometimes factually incorrect. Observers suggest Mr Kennedy may be attempting to use this argument to justify less definitive vaccine recommendations.
The RFI gives notable consideration to the Shared Clinical Decision-Making (SCDM) category, which is currently used infrequently. The Meningococcal B vaccination is cited as one of the few vaccines for which an SCDM recommendation applies. The RFI characterises SCDM as an “intermediate category” that “provides no default” choice regarding a vaccination, thereby avoiding a “binary choice between a universal recommendation and no recommendation at all.”
The document further elaborates: “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.” However, the RFI also acknowledges that the use of SCDM has historically led to confusion. It invites public opinion on its potential expanded future application.
Beyond the focus on SCDM, the RFI also solicits other potential category options. It offers several illustrative ideas, including “recommended, but not during infancy,” “recommended with qualification,” or “shared clinical decision-making with qualification.” The document does not provide further elaboration on the specific meanings or implications of these additional suggested categories.
