Independent review launched after U.S. shifts to single-dose HPV schedule

CHICAGO, Jan. 8, 2026, The Vaccine Integrity Project at the University of Minnesota said on Jan. 8 it will carry out a transparent, independent review of the evidence for the human papillomavirus vaccine after federal health agencies revised the national immunization schedule to favor a single HPV dose at age 11.

The U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention this week recommended a single dose, departing from the Food and Drug Administration-approved two- or three-dose regimens. That shift occurred as the Advisory Committee on Immunization Practices was still assessing single-dose data, and the committee was disbanded before completing its review. HHS Secretary Robert F. Kennedy Jr. has publicly criticized the HPV vaccine, calling it "the most dangerous vaccine ever invented."

The Vaccine Integrity Project, an initiative of the University of Minnesota’s Center for Infectious Disease Research and Policy established in April 2025, said it will publish findings aimed at informing clinicians, medical societies and policymakers. CIDRAP Director Michael Osterholm frame d the effort as rooted in restoring clarity. "Ensure that policymakers, clinicians, and the public have an accurate understanding of what the data actually show," he said, adding "while we’re not ACIP, we’re trying to fill in the deficits in science information that have occurred."

The single-dose conclusion is one that the World Health Organization has endorsed after international evidence suggested a single dose can prevent most HPV-related cancers. Nonetheless, the federal situation in the United States now presents a mismatch between regulatory approval and national guidance: the FDA continues to approve two- or three-dose schedules, while CDC and HHS guidance has moved to a one-dose standard.

Manufacturers have pushed back on the regulatory implications. Merck, maker of Gardasil, told reporters that Gardasil lacks data to support approval for a single-dose schedule. At the same time, the WHO’s Global Advisory Committee on Vaccine Safety has previously reviewed HPV vaccine safety and found that surveillance of more than 175 million distributed doses continued to support the vaccine’s safety profile, with investigations of serious adverse events not confirming causal links.

Public health experts warn that the way the recommendation was changed could erode trust in immunization programs. A sudden policy shift without the usual advisory review risks fueling confusion among clinicians, insurers and families, particularly in communities already facing barriers to preventive care. Advocates note that a single-dose schedule could lower access barriers and reduce disparities in cervical cancer prevention for low-income and rural populations, but only if accompanied by clear communication and equitable implementation.

Lessons from Japan, where a suspension of proactive HPV recommendation followed reports of chronic pain among some recipients and left vaccination rates depressed, underscore the stakes: when consensus fractures, young people can be left vulnerable to preventable cancers.

The Vaccine Integrity Project’s review will be closely watched by clinicians and public health officials seeking independent analysis amid the regulatory divergence. The group has said it will make its methods and findings public, but it has not released a timeline for completion.