RFK Jr.'s HHS asks public to weigh in on new vaccine categories
The US health department under Health Secretary Robert F. Kennedy Jr. is considering changing how vaccine recommendations are categorized and described. Kennedy laid out the idea in a Request for Information (RFI), a 10-page document posted online on a Friday and published in the Federal Register the following Monday. The RFI poses questions about the current categories and invites the public to submit ideas for changing or replacing them; the comment deadline is September 20.
Currently, the Centers for Disease Control and Prevention grants vaccine recommendations in three categories, informed by the Advisory Committee on Immunization Practices (ACIP), a panel of independent expert advisors. "Routine," also called universal, means everyone should get a given vaccine. "Risk-based" means only certain higher-risk groups should get it. "Shared clinical decision-making" (SCDM) is a flexible, uncommon designation based on the characteristics, values and preferences of a patient together with the judgment of their healthcare provider.
The RFI raises the possibility that recommendations now labeled routine or universal could instead be given designations that sound less definitive or more conditional, such as "recommended with qualification" or a recommendation folded into the shared-clinical-decision-making category. Kennedy has not adopted any new rules or recommendations yet; these are floated as possibilities on which the public is asked to comment.
Before Kennedy's oversight, the CDC and ACIP used an evidence-based decision-making framework to decide which category applied to a given vaccine. Kennedy's RFI cites an executive order on vaccines that Trump signed two weeks earlier, which aimed to slash and overhaul federal vaccine recommendations, as the basis for the effort.
Key facts
- HHS posted the RFI online on a Friday and published it in the Federal Register the following Monday; it runs 10 pages, and the public comment deadline is September 20.
- The CDC currently grants vaccine recommendations in three categories: routine/universal, risk-based, and shared clinical decision-making (SCDM), the last based on a patient's characteristics, values and preferences together with a provider's judgment.
- The RFI floats possible new, more conditional designations, such as "recommended with qualification," for vaccines now labeled routine or universal, without adopting any of them.
- The RFI cites a Trump executive order on vaccines, signed two weeks earlier, that aimed to slash and overhaul federal vaccine recommendations.
- No new categories or rules have been adopted; Kennedy's document only poses questions and solicits public comment.
Why it matters
This RFI is a first concrete step under Kennedy's oversight toward changing how the federal government officially labels vaccine recommendations, following Trump's executive order aimed at overhauling federal vaccine guidance. The category a vaccine carries determines whether federal guidance reads as unconditional advice that everyone should follow or as something narrower and conditional, so changing the categories changes the tone of official vaccine guidance itself, even before any single vaccine's recommendation is touched.
Who it affects
The CDC and ACIP, which currently set and review these categories, are the direct subject of the RFI. Patients and the healthcare providers who apply the shared-clinical-decision-making category in practice are named in its definition. Anyone who wants a say has a concrete channel: the public comment period that closes September 20.
How to use it
The RFI is open for public comment through September 20, via the Federal Register posting Kennedy's document appeared in. That is the window for anyone who wants to respond to the specific questions it raises about the current three categories.
How solid is it
The RFI itself is a primary document: it was posted online and published in the Federal Register, and the reporting is based directly on its text. What it is not is a decision. Kennedy has made no new rules or recommendations yet; the new category labels are examples raised for comment, not adopted designations, and nothing here indicates whether or when any change would follow the comment period.
Risks and caveats
Ars Technica's reporting states there is no clear, evidence-based reason to question the current categories, nor evidence to support the alternatives Kennedy proposes, in contrast to the evidence-based framework the CDC and ACIP used before Kennedy's oversight. The RFI does not name any individual CDC or ACIP official, and it does not lay out a process or date for what happens after the comment period closes.
“There is no clear, evidence-based reason to question the current categories, nor any evidence to support changing to the new categories Kennedy proposes.”
— Ars Technica