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The Trump administration is asking for public feedback on changes to the ways it recommends vaccines – likely opening the door to greater access challenges and confusion, experts say.
In a notice published by the health and human services (HHS) to the Federal Register on Friday, officials say they are now seeking comments from the public about the current categories for vaccine recommendations, which so far fall into 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 says.
The administration also wants feedback on whether “additional or different categories should be adopted”.
Asking for public comments is “appropriate and right”, said Dorit Reiss, vaccine law expert and professor at UC Law San Francisco. One of her criticisms about HHS is that “they haven’t been doing it anywhere near enough”, she said.
But the notice is strange, she said. This kind of categorization would normally be taken up by experts in the Centers for Disease Control and Prevention (CDC) or the CDC’s advisory committee on immunization practices (ACIP); that was what happened when officials created the “shared clinical decision-making” category and when they adopted Grade, the system for evaluating evidence.
There is widespread confusion about what terms such as “shared clinical decision-making” actually mean.
“A review of the current categories may be appropriate – certainly the ‘shared clinical decision making nomenclature’ is confusing,” said Wendy Parmet, a public health law scholar at Northeastern University.
But it is “troubling” that this process has been initiated by HHS, in support of the taskforce on safer childhood vaccines implemented by Robert F Kennedy Jr, a longtime vaccine opponent and current HHS secretary – rather than by ACIP or CDC.
That “raises the possibility that the final decision will be made without the benefit of relevant expertise”, Parmet said.
Creating new categories could also increase confusion about who qualifies for vaccines and whether they are recommended for a patient. While it is likely that the routine recommendation category will still exist, adding several new categories appears to be “aimed at limiting vaccine access and causing confusion”, Reiss said.
The public is also asked to comment on which considerations should inform vaccine recommendations, including how to evaluate the strength of existing scientific evidence and how to approach cases where randomized controlled trial evidence is “limited or absent”.
That’s not “inevitably problematic”, Parmet said, but “the question is how they do the assessment, which gets me back to the worry about their sidestepping CDC” and other relevant experts.
The move comes after Donald Trump signed an executive order earlier this month directing federal agencies to pare back vaccine recommendations – mirroring an unprecedented change in the vaccine recommendations from the HHS in January, which was halted in March by a federal judge.
While the executive order cannot change vaccine recommendations, which remain the same as before Trump took office, experts have noted it will likely sow confusion and doubt.
Friday’s notice mentions the executive order but does not seem to reference the HHS move or the lawsuit. The notice also tackles vaccine mandates, which are not set at the federal level except for the military. Vaccine requirements for school attendance are set at the state and local level, putting them outside of the purview of HHS, Reiss noted.
The public has 30 days to submit comments, which is a “pretty short” timeline, she said.
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