by Jon Fleetwood, Jon Fleetwood:
After “premature, overconfident” COVID-era recommendations, HHS questions “universal” vaccination and considers “recommended, but not during infancy.”
The Department of Health and Human Services (HHS) is seeking public comment on whether federal vaccine recommendations should operate with “a presumption in favor of individual autonomy, informed consent, and religious freedom,” as the agency reconsiders the framework used to recommend vaccines nationwide.
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You can submit a comment here.
The request appears in a Monday Federal Register notice signed by HHS Secretary Robert F. Kennedy Jr. and issued in support of the Task Force on Safer Childhood Vaccines and President Donald Trump’s Aug. 10 executive order on childhood vaccine recommendations.
HHS says it is reconsidering the three categories currently used by the federal government: routine, or “universal,” recommendations; risk-based recommendations; and shared or individual clinical decision-making.
The agency states:
“The Department seeks comment on these categories and whether additional or different categories should be adopted. The Department further seeks comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence, the appropriate approach when randomized controlled trial evidence is limited or absent, a presumption in favor of individual autonomy and religious freedom, the downstream legal and programmatic consequences of category assignment, and the communication practices necessary to earn and maintain public trust.”
Under the existing system, HHS says a routine recommendation carries an explicit default:
“Under a routine (universal) recommendation, the default is to vaccinate all persons in an age group absent contraindications.”
By comparison, CDC guidance says that under shared clinical decision-making, “there is no default.”
Public comments are due September 20.
Interested persons are also given the following instructions:
“Interested persons are invited to submit written comments identified by Docket No. HHS-OS-2026-0332 by either of the following methods: (1) Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments; or (2) Mail: Cynthia Goss, 200 Independence Ave SW, Washington, DC 20201. All submissions received must include the agency name and docket number. Comments received will be posted without change to https://www.regulations.gov, including any personal information provided.”
For further information, requesters are asked to contact:
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