Trump administration asking public comment on vaccine recommendations

HHS opens public comment on vaccine recommendation overhaul

The Department of Health and Human Services (HHS) has opened a 30-day public comment period on how the federal government categorizes vaccine recommendations, a move that could reshape how shots are described to the public. Health Secretary Robert F. Kennedy Jr. posted a Request for Information (RFI) on Friday that was published in the Federal Register on Monday, with comments due by September 20.

The RFI asks whether the current three-tier structure—routine or universal, risk-based, and shared clinical decision-making (SCDM)—should be replaced or supplemented. It floats new designations such as "recommended with qualification" and "shared clinical decision-making with qualification," as well as "recommended, but not during infancy."

Kennedy wrote that "the durability of any vaccine recommendation framework depends on the public's trust in the process that produces it," citing a measurable decline in trust in federal public health agencies during the COVID-19 pandemic. The RFI also asks whether the current categories "unintentionally imply that parental permission, individual consent, or meaningful clinical discussion applies only to shared clinical decision-making recommendations" and whether categories convey "meaningful differences in the strength of evidence" and the magnitude of benefits.

Executive order sets the stage

The request comes two weeks after President Donald Trump signed an executive order calling for a reduction in the number of childhood vaccines recommended by the Centers for Disease Control and Prevention (CDC) from 17 to 11. The order also directs the Justice Department to challenge state-level vaccination mandates for school entry and calls for unbundling the measles-mumps-rubella (MMR) vaccine into separate doses.

According to administration officials speaking to The Independent, the order was driven by Trump's frustration over the lack of progress on autism research, an issue that has animated Kennedy's agenda. Five current and former officials said the directive does not fundamentally transform immunization policy on its own, but Kennedy and his supporters are prioritizing agency studies on vaccine dangers, including a possible autism link.

Medical experts and scientists say the autism-vaccine link has been thoroughly disproven by research involving millions of children. The RFI itself does not mention autism, but its timing and content align with the administration's stated priorities.

Controversy over process and substance

The RFI has drawn scrutiny from public health experts who question both its motivations and its process. Dorit Reiss, a vaccine law expert at UC Law San Francisco, called public input "appropriate and right" but said HHS "haven't been doing it anywhere near enough." Wendy Parmet, a public health law scholar at Northeastern University, said the SCDM terminology is "confusing" and that it is "troubling" the process was initiated by HHS rather than the CDC or its Advisory Committee on Immunization Practices (ACIP), the bodies traditionally responsible for such decisions.

The concern, as one expert put it, is that new categories could be "aimed at limiting vaccine access and causing confusion." The Independent reported that Kennedy previously attempted to slash CDC recommendations to match Denmark's schedule and introduced a reduced immunization schedule in January, both of which were blocked by a federal judge in March. A U.S. judge also blocked the government's decision to remove routine recommendations for six vaccines.

Kennedy has also replaced the ACIP's 17 expert members with hand-selected allies, a move that a federal judge temporarily blocked in litigation led by the American Academy of Pediatrics (AAP). The judge ruled in March that Kennedy's vaccine changes and ACIP appointments were likely illegal and done without proper procedure, according to Ars Technica.

State pushback and political context

The RFI's suggestion that SCDM could become the default category for all vaccines has drawn particular attention, as it could shift the framing of many routine shots from universal recommendations to individualized decisions. The executive order also directs the CDC to recommend staggering vaccine doses in childhood, a proposal that has been met with resistance from pediatric groups.

More than two dozen states and the District of Columbia have rejected the CDC's recent recommendations, with most following guidelines from the American Academy of Pediatrics, according to the Spokane Spokesman-Review. That number was reported as "a dozen" by one outlet, highlighting discrepancies in reporting on the exact count.

CDC Director Erica Schwartz, who has been on the job for just over a week, faced questioning from Sen. Bill Cassidy (R-La.) about her ability to push back against science. Trump also selected Heidi Overton as his FDA nominee, drawing backlash from Cassidy.

Perspectives

Administration and allies: White House spokesman Kush Desai said Trump was acting on behalf of "countless parents (who) have had their questions and concerns about America's childhood vaccine schedule ignored if not outright mocked." Del Bigtree, CEO of the Informed Consent Action Network, called the executive order "only the beginning of a process that had to happen," emphasizing the need for credible science to back lasting change.

Public health and legal experts: Experts such as Dorit Reiss and Wendy Parmet welcomed the public comment process but questioned its provenance and potential consequences. Reiss said HHS hasn't been doing enough public engagement, while Parmet flagged confusion over SCDM and the "troubling" bypass of CDC/ACIP expertise. The Guardian quoted a scholar who raised the possibility that final decisions could be made "without benefit of relevant expertise."

Medical establishment: The American Academy of Pediatrics has led litigation against Kennedy's prior changes and has encouraged states to reject the reduced schedule. Scientists and medical experts emphasize that the autism link is thoroughly disproven, and a federal judge has blocked several of the administration's vaccine-related actions as likely illegal.