Health Officials and Legal Scholars Warn of Confusion as HHS Seeks Public Input on Vaccine Policy Changes

The U.S. Department of Health and Human Services (HHS) is inviting public commentary on potential revisions to the framework used for federal vaccine recommendations, a move that medical and legal experts fear could lead to increased confusion and barriers to vaccine access.

In a notice published in the Federal Register on Friday, HHS stated it is soliciting feedback on the current classification system for vaccine recommendations, which currently includes categories such as routine, risk-based, and shared clinical decision-making.

“Public input received in response to this notice will help inform consideration by the Department and the Task Force of whether the current category structure adequately serves the goals of scientific rigor, informed choice, and public trust,” the notice read.

The administration is also requesting input on whether new categories should be introduced or existing ones modified.

While soliciting public feedback is “appropriate and right,” said Dorit Reiss, a vaccine law expert and professor at UC Law San Francisco, she criticized HHS for not engaging in the practice frequently enough. She also expressed concern over the manner in which the initiative was launched.

Typically, such categorization falls under the purview of the Centers for Disease Control and Prevention (CDC) or its advisory panel, the Advisory Committee on Immunization Practices (ACIP). It was through this standard process that previous categories—such as shared clinical decision-making—and systems like GRADE were developed.

“There is widespread confusion already regarding what terms like ‘shared clinical decision-making’ mean,” said Wendy Parmet, a public health law scholar at Northeastern University.

Parmet acknowledged that reviewing the existing framework may be warranted, particularly given the ambiguity surrounding certain terminologies. However, she found the approach taken by HHS troubling, especially considering the leadership of the Department’s Task Force on Safer Childhood Vaccines by Robert F. Kennedy Jr.—a well-known vaccine skeptic and current HHS Secretary.

“This raises the possibility that the final decision will be made without the benefit of relevant expertise,” Parmet warned.

Introducing additional categories could further muddy public understanding of who qualifies for specific vaccines and whether they are recommended for individual patients. According to Reiss, while the standard recommendation category is likely to remain intact, any expansion of classifications appears designed to restrict access and foster uncertainty.

The public is also being asked to provide input on the factors that should guide vaccine recommendations, including how to assess the robustness of scientific evidence and how to proceed when randomized controlled trials yield limited or no data.

According to Parmet, this aspect of the review is not inherently problematic. However, she emphasized that the methodology used in conducting the assessment remains a critical concern, particularly due to HHS bypassing established bodies like the CDC.

This latest development follows an executive order signed by President Donald Trump earlier this month directing federal agencies to scale back vaccine recommendations. The order echoes an unprecedented policy shift announced by HHS in January, which was later suspended in March after a federal court intervened.

Although the executive order does not have the authority to alter official vaccine recommendations, experts caution that such actions may generate confusion among both healthcare providers and the general public.

Notably, the notice references the executive order but makes no mention of the January policy change or the subsequent legal challenge. It also touches on vaccine mandates—an area largely governed at the state and local levels, particularly for school entry requirements, which fall outside HHS jurisdiction, according to Reiss.

The public has been given 30 days to submit their comments—a timeframe that Reiss described as “pretty short.”

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