An independent panel, the Vaccine Integrity Project at the University of Minnesota, will review the evidence after the CDC recommended a single HPV vaccine dose at age 11—an approach that diverges from FDA‑approved two- or three-dose regimens. The CDC adopted the change without the usual ACIP review after HHS leadership was replaced; experts say open questions remain about effectiveness for older teens, immunocompromised people and long-term protection. Merck says current data are insufficient for FDA single-dose licensure; Gardasil sales reached $2.4 billion in the U.S. in 2024.
Independent Panel To Review Evidence After CDC Moves To Single‑Dose HPV Recommendation
The exterior of the Centers for Disease Control and Prevention in Atlanta, Georgia, U.S., December 5, 2025. REUTERS/Alyssa Pointer
CHICAGO, Jan 8 (Reuters) - An independent vaccine advisory group announced it will conduct a scientific review of the evidence behind a new U.S. recommendation that children receive a single dose of the human papillomavirus (HPV) vaccine—a change that departs from the vaccine's current FDA-approved two- or three-dose schedules.
Background
The U.S. Centers for Disease Control and Prevention (CDC) this week recommended that routine HPV vaccination be given as a single dose at age 11, rather than the two- or three-dose regimens previously advised depending on age at initiation. The World Health Organization has said emerging data suggest one dose may prevent most HPV-related cancers, but the CDC's change did not follow the agency's customary advisory review process.
Bypassing Traditional Review
Rather than completing a review through the CDC's Advisory Committee on Immunization Practices (ACIP), the agency adopted the change after a senior Health and Human Services (HHS) staff review of vaccine schedules used in other developed countries. That step came after President Donald Trump urged a reduction in childhood vaccine doses. In June, HHS Secretary Robert F. Kennedy Jr., a long-time vaccine critic, dismissed all 17 ACIP members and replaced them with new advisers; several major medical organizations have since challenged the reconstituted panel's policies in court.
Why An Independent Review?
The Vaccine Integrity Project at the University of Minnesota announced it will review the single-dose evidence to provide an independent scientific assessment. "While we're not ACIP, we're trying to fill in the deficits in science information that have occurred," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy. "Our goal is to ensure that policymakers, clinicians, and the public have an accurate understanding of what the data actually show."
Open Questions
Experts say important questions remain. James Campbell, a pediatrics professor at the University of Maryland School of Medicine and former ACIP work group member, noted unresolved issues including whether a single dose provides sufficient and durable protection for older adolescents, immunocompromised people, or whether there are differences in response between males and females.
Current Guidance And Industry Response
The American Academy of Pediatrics currently recommends two HPV doses for children aged 9–12 and three doses for those who start after age 15. Merck's Gardasil—the only HPV vaccine licensed in the United States—is approved on a two-dose basis. Merck said there is not yet sufficient data for the Food and Drug Administration to license a single-dose regimen. The company reported $2.4 billion in U.S. Gardasil sales in 2024.
Project Track Record And Funding
The Vaccine Integrity Project, formed last year, has published reviews of changes to influenza, COVID-19 and RSV vaccine recommendations and recently analyzed evidence on hepatitis B vaccination after HHS rescinded longstanding guidance on universal newborn hepatitis B immunization. The project is funded by the Alumbra Innovations Foundation, established by philanthropist Christy Walton, and says it accepts no pharmaceutical industry funding.
Next Steps
The independent review aims to clarify the strength and limits of the evidence for a single-dose HPV strategy and to inform clinicians, policymakers and the public. Pending further analysis, professional groups and regulatory agencies will need to weigh durability of protection and special-population recommendations before aligning practice and licensing.
Reporting: Julie Steenhuysen. Editing: Bill Berkrot.
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