Key facts
- Health Secretary Robert F. Kennedy Jr. is exploring changes to how vaccine recommendations are categorized.
- The US Department of Health and Human Services published a Request for Information (RFI) seeking public input on potential new vaccine recommendation categories.
- Current categories include 'routine,' 'risk-based,' and 'shared clinical decision-making' (SCDM).
- Proposed new categories include 'recommended with qualification' and 'shared clinical decision-making with qualification.'
- The RFI also asks about incorporating considerations of individual autonomy and religious freedom.
- The deadline for public comments on the RFI is September 20.
Health Secretary Robert F. Kennedy Jr. is initiating a process to potentially alter how vaccine recommendations are categorized and described by the US health department. This move could lead to vaccinations currently classified as 'routine' or 'universal' being given less definitive labels, such as 'recommended with qualification' or based on 'shared clinical decision-making.'
Kennedy has not yet established new rules but has outlined possibilities in a Request for Information (RFI) published online and in the Federal Register. The RFI poses questions about the existing categorization system and invites public comment on potential changes, with a deadline of September 20.
Currently, the Centers for Disease Control and Prevention (CDC), guided by the Advisory Committee on Immunization Practices (ACIP), uses three categories: routine (universal), risk-based, and shared clinical decision-making (SCDM). Historically, these decisions have been based on an evidence-based framework.
The RFI suggests a potential shift, asking the public to consider recommendations made with a 'presumption in favor of individual autonomy and religious freedom' and how to address recommendations when robust trial evidence is lacking. This approach could be used to justify less definitive vaccine endorsements.
The RFI specifically highlights SCDM as a potential model, describing it as an 'intermediate category' that allows for more discussion between patients and providers, weighing evidence alongside personal values and preferences. However, the RFI also notes that SCDM has previously caused confusion.
This initiative follows an executive order signed by President Donald Trump aimed at overhauling federal vaccine recommendations. Critics, including the American Academy of Pediatrics, have filed a lawsuit, with a federal judge temporarily blocking some of Kennedy's previous changes to vaccine recommendations and ACIP appointments, deeming them likely illegal and procedurally flawed.