In the wake of a controversial executive order that shrinks the number of universally recommended vaccines for children, HHS is asking the public to weigh in on whether three categories used in federal vaccine recommendations are adequate.
The three categories up for discussion are routine, risk-based, and shared clinical decision-making. The agency is seeking input on whether it should implement additional or different categories.
The request for information posted to the Federal Register asks whether the currently used categories "convey meaningful differences in the strength of the evidence, the magnitude of individual and population benefit, and the room left for individual circumstances and values," and whether they "unintentionally imply that parental permission, individual consent, or meaningful clinical discussion applies only to shared clinical decision-making recommendations."
In addition, HHS proposes adding additional categories of recommendations like "recommended, but not during infancy," "recommended with qualification," and "shared clinical decision-making with qualification."
Moreover, the agency inquires about the potential benefits of shared clinical decision-making, including "respect for autonomy, informed consent, religious conviction, and individualized clinical judgment," and the potential risks of "confusion, reduced access or uptake, and time burdens in practice."
Richard Hughes IV, JD, the attorney representing the American Academy of Pediatrics in its lawsuit against HHS, said in emailed remarks that the request for information, "framed as an open inquiry, is anything but."
"Read against the backdrop of the administration's actions in vaccine policy, it is the latest step in a predetermined policy agenda to restructure the federal vaccine recommendation framework, this time with the procedural veneer of public input," Hughes said.
He noted that the development of the shared clinical decision-making category was developed by the CDC's Advisory Committee on Immunization Practices over many years and involved considerable deliberation. "Under the guise of simply requesting information, the administration is now making clear its intent to modify existing recommendation categories, or even create new ones," Hughes wrote.
The request for information also floats the idea that recommendations from peer agencies abroad should be incorporated into U.S. guidance. HHS Secretary Robert F. Kennedy Jr. has previously commented on President Donald Trump's wish to "align the U.S. childhood vaccine schedule with international consensus."
It also puts forward considerations for setting vaccine recommendations. "Commenters are specifically invited to address the availability, quality, and strength of evidence; the appropriate approach where randomized controlled trial evidence is absent, infeasible, or unethical to obtain; disease severity and epidemiology; individual versus population benefit; a presumption in favor of individual autonomy, informed consent, and religious freedom; and feasibility and programmatic consequences," the document stated.
Finally, HHS poses questions about the effects of vaccine mandates and lessons learned from vaccine communications during the COVID-19 pandemic.
It remains to be seen exactly how HHS will use the responses gathered through the request for information. Responses are due by Sept. 20.
Major medical organizations, including the Infectious Diseases Society of America, are likely to submit public comments.