PFID Urges HHS to Reject Further Complicating Childhood Vaccine Recommendations
Read PFID's full RFI comment letter here.
The Partnership to Fight Infectious Disease responded to the U.S. Department of Health and Human Services (HHS)’s Request for Information (RFI) about childhood vaccine recommendations with a clear warning and call to action:
HHS should retain the existing, evidence-based vaccine recommendation categories because changing them without new scientific justification would confuse families and providers, jeopardize access and coverage, and further erode public trust.
Stemming from the August 10 Executive Order on childhood vaccinations – which leading medical experts decried as misguided and harmful – HHS is seeking public input on the categories used in federal vaccine recommendations, including the role of the shared clinical decision-making (SCDM) recommendation category.
Below are key takeaways from PFID's response to each component of the RFI.
Universal recommendations already involve patient-provider discussions and informed consent.
For decades, the Advisory Committee on Immunization Practices (ACIP) developed recommendations using two structured tools. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method rates the certainty of scientific evidence, and the Evidence to Recommendations (EtR) framework weighs disease burden, benefits and harms, feasibility, and equity before any vote. The result is a transparent link between the medical and scientific evidence and the recommendation for each vaccine specific to the individuals at risk of illness.
The existing categories are extensively studied and are not the source of public confusion. Actions to downgrade universal recommendations ignore the fact that provider-patient conversations about benefits and risk and informed consent are already a part of every decision to vaccinate or not, regardless of the recommendation category.
There is no new evidence to justify changing the categories.
Making arbitrary changes and adding complexity will only make the recommendations harder for physicians and families to follow. Changes could also restrict access for millions of Americans since meeting conditions of insurance coverage, no-cost-sharing protections, Vaccines for Children eligibility, and state pharmacy laws are often tied to federal vaccine recommendations.
The public shares these concerns. According to polling, 9 in 10 voters say recommendations should come from independent medical experts free of political influence and 60% worry that people who want vaccines won't be able to get them because of federal changes or confusion.
Clarity and transparency remain paramount.
ACIP created shared clinical decision-making (SCDM) as a vaccine recommendation category in 2019 for cases where a vaccine's expected benefit varied among individuals, such as HPV vaccination for adults ages 27 through 45. SCDM does not signal that a vaccine is less safe or effective, and it was designed around infection risk, not personal beliefs. Considerations of personal concerns and beliefs are handled as part of individual discussions between provider and patient or caregiver.
Rather than reshape the category, we urge HHS to ensure parents and families understand the distinction in situations where medically backed data supports a SCDM recommendation. According to the Annenberg Public Policy Center, just 22% of people can correctly identify what SCDM means.
We’re also concerned ACIP's restructuring and this Request for Information process outside the normal ACIP processes circumvent the gold-standard equivalent evidence-to-review process that traditionally informed recommendations and recommendation categories to the detriment of the public. Changes in recommendations should include a thorough GRADE assessment and EtR table involving qualified experts and provide opportunities for public comment before adoption. This is a health necessity, not a procedural shortcut.
Communicating vaccine risk requires context alongside their benefits and risks of vaccine-preventable illnesses.
Serious vaccine injuries are exceedingly rare: across more than 5.65 billion vaccines doses distributed from 2006-24, the Vaccine Injury Compensation Program awarded compensation in fewer than two cases per million doses. Meanwhile, routine childhood vaccinations have prevented an estimated 508 million illnesses and more than one million deaths. Yet kindergarten vaccination coverage declined for every reported vaccine in the 2025-2026 school year, and for the second year in a row, the nation is facing its worst measles outbreaks since the early 1990s.
Clarity, access, and trust go hand in hand. We urge HHS to preserve the evidence-based framework that has protected Americans for decades and stand ready to support efforts grounded in science and transparent communication.
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