Biologics

HHS Seeks Input on Categories of Federal Vaccine Recommendations

HHS is seeking public input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enough choice and clearly reflects the strength of scientific evidence. A new Federal Register notice says the Department is reviewing three existing categories: routine recommendations, which generally apply to everyone in an age group; risk-based recommendations for people with particular risk factors; and shared clinical decision-making, in which patients or parents and health care providers decide whether vaccination is appropriate based on individual circumstances.

The info request is intended to support HHS’ Task Force on Safer Childhood Vaccines and follows a recent executive order (see earlier story) directing HHS to develop "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended and giving parents more flexibility in vaccination decisions. The order calls for routine immunization recommendations covering 11 diseases, down from 18 diseases included in the CDC's 2024 childhood schedule. Vaccines no longer routinely recommended for all children would instead be subject to shared clinical decision-making between parents and clinicians, according to the White House.

The HHS notice says it wants input on whether the current categories should be changed or expanded. It is also seeking views on how much weight should be given to scientific evidence when evidence from randomized clinical trials is limited, as well as individual autonomy, religious freedom, the legal and programmatic effects of vaccine classifications, and how federal agencies communicate recommendations to the public.

The notice notes that shared clinical decision-making has generated both support and criticism. HHS cites research showing that physicians often find such recommendations more time-consuming and that patients can be confused about what they mean. At the same time, supporters say the approach provides an important middle ground for vaccines whose benefits may vary by individual circumstances or where evidence is limited or evolving.

HHS is accepting public comments through 9/20.

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Overton Confirmation Remains Uncertain After Senate Hearing

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