What Pharmacists Should Know
- HHS has reorganized the childhood vaccine schedule into universal, high-risk, and shared decision-making categories, shifting several routine vaccines away from default recommendation status.
- Foundational vaccines, including hepatitis B, influenza, hepatitis A, meningococcal, and HPV, now require more individualized counseling, increasing the pharmacist’s role in patient education.
- Pharmacists should be prepared to address concerns about these changes, particularly as they were made without ACIP or major professional organization endorsement.
In this Pharmacy Times® Explainer, Jeffery A. Goad, PharmD, MPH, professor of pharmacy practice at Chapman University School of Pharmacy, discussed recent policy changes by the US Department of Health and Human Services (HHS) that significantly restructure the childhood immunization schedule. Goad explained that vaccines are now categorized into 3 groups: those that remain universally recommended, those indicated for specific high-risk populations, and those placed under shared clinical decision-making. This third category represents a major shift, as vaccination is no longer the default and instead depends on individualized discussions between providers and families.
Under the new guidance, several foundational childhood vaccines have been removed from universal recommendation status. These include components of hepatitis B, influenza, hepatitis A, and meningococcal vaccines, which have been moved into either shared decision-making or high-risk categories. Goad emphasized that such changes could lead to decreased vaccination rates and greater variability in protection across populations. He also highlighted significant modifications to human papillomavirus (HPV) vaccination recommendations. The schedule has been reduced from a 2-dose to a single-dose series, despite the American Academy of Pediatrics (AAP) continuing to support a 2-dose regimen for optimal cancer prevention.
“Shared clinical decision-making was originally intended for situations where individuals may benefit from vaccination, but broad vaccination of that group is unlikely to have population-level impact—not for routine childhood vaccines.” - Jeffery A. Goad, PharmD, MPH
Goad expressed concern that these changes were implemented without recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) or endorsements from major medical or pharmacy organizations. HHS has suggested the revisions align the US more closely with countries such as Denmark; however, Goad noted that such comparisons are flawed due to major differences in health care infrastructure, population diversity, access to care, and follow-up systems.
From a pharmacist’s perspective, these policy shifts introduce new challenges in patient counseling, documentation, and vaccine advocacy. Goad stressed that shared clinical decision-making was originally intended for vaccines with limited population-level impact, not for routine childhood immunizations that have historically driven widespread disease prevention. Pharmacists will need to engage more actively in education and shared decision-making conversations to prevent gaps in pediatric vaccine coverage.
