What Stakeholders Told HHS About Childhood Vaccine Recommendation Categories

Read PFID’s full RFI comment letter here.

The U.S. Department of Health and Human Services (HHS) asked the public whether federal vaccine recommendation categories should change, and physicians, nurses, public health experts, legal advocates, employers, and patient groups responded with a consistent message: the current framework works, and changing it without new evidence would put children, families, and access to care at risk.

The Request for Information (RFI), issued in support of the August 10 Executive Order, asked whether the routine, risk-based, and shared clinical decision-making categories are adequate and whether different categories should be adopted. HHS floated new options including "recommended, but not during infancy," "recommended with qualification," and "shared clinical decision-making with qualification."

Below are key themes from what stakeholders told HHS.

There is no scientific case for changing the categories.

A group of health advocacy organizations and scholars, including the American Public Health Association (APHA), the Robert Wood Johnson Foundation, and Dr. Bruce Gellin, former director of the HHS National Vaccine Program Office, wrote in a joint comment letter that nothing supports “the RFI's implicit suggestion that the current framework produces unsafe results or needs fundamental revision.” The National Health Law Program urged HHS to refrain from any changes to the current categories and to return to decisions based on science and clinical evidence.

Decisions belong in the established, evidence-based process.

The National Foundation for Infectious Diseases urged that the “RFI should inform, but not replace, the established Advisory Committee on Immunization Practices (ACIP) process for determining whether categories are added, removed, renamed, or redefined.” NFID also emphasized that “vaccination, like all medical care, requires informed consent regardless of how a recommendation is categorized”. The American Academy of Nursing stressed that federal bodies setting vaccine policy should include “members with robust expertise in vaccination and immunization.” Richard Hughes IV, counsel to the American Academy of Pediatrics in its lawsuit against HHS, said the RFI, "framed as an open inquiry, is anything but," and noted that ACIP developed the shared clinical decision-making category over many years of deliberation.

New categories would create confusion, not clarity.

The American Academy of Nursing raised serious concerns about adding categories, noting that some proposals, such as "recommendation with qualification," leave room for confusion. The joint comment letter lead by APHA, warned that categories proposed without context, evidence, or a communication strategy would produce confusion and uncertainty, likely leading to missed doses and the return of vaccine-preventable diseases.

Coverage, access, and the workforce are on the line.

The U.S. Chamber of Commerce urged HHS to evaluate the unintended coverage implications of any category changes and to account for workforce impacts when debating changes to the immunization schedule. Public health experts, David Higgins, MD, MPH, epidemiologist Katelyn Jetelina, and Jess Steier, DrPH, explained, in practical terms, that the ACIP link is what guarantees no-cost coverage, and a vaccine that loses it could face a “copay, a prior authorization hurdle, or no coverage at all.”

Thousands of individuals weighed in.

Chapters of the American Academy of Pediatrics (AAP), including Ohio and Wisconsin, urged pediatricians to submit comments emphasizing that childhood vaccine recommendations must stay grounded in strong scientific evidence and pediatric expertise. Before the deadline, a coalition of 70 organizations, led by the AAFP, asked HHS to extend the comment period to October 23, saying 30 days did not allow enough time for thoughtful responses.

What does HHS mean by "radical transparency"?

More than 35,000 comments were filed. HHS has posted 16. Without the full docket, no one outside the Department can see the balance of views, how many were form letters, or which arguments HHS will weigh.

Secretary Kennedy has repeatedly promised "radical transparency." At his confirmation hearing, he said it was how he would address public skepticism of health agencies, and he later pledged to make HHS's policy process so open that no one would need to file a FOIA request. The Federal Registrar noted that received comments would be posted without change.

We respectfully ask HHS: What does "radical transparency" mean if the public cannot read what the public submitted? Before acting on this RFI, HHS should post all comments and explain how they informed its decisions.

Clarity, access, and trust go hand in hand. The stakeholders who know vaccines best have spoken, and HHS should listen.