By Julie Steenhuysen
CHICAGO, Jan 8 (Reuters) – An independent vaccine advisory group said on Thursday it will conduct a scientific evidence review of a vaccine used to prevent cervical and other cancers that U.S. health officials this week said should only be given as a single dose, contrary to the shot’s FDA approval.
The change by the U.S. Centers for Disease Control and Prevention sidestepped the traditional U.S. review process.
The new schedule recommends U.S. children receive a single dose of human papillomavirus (HPV) vaccine at age 11, rather than the recommended two or three doses, which varies based on the age when the shots are started.
The Vaccine Integrity Project, which is based at the University of Minnesota, was formed last year to offer independent reviews of vaccine evidence akin to those previously done by the CDC’s Advisory Committee on Immunization Practices.
In June, Health and Human Services Secretary Robert F. Kennedy Jr., a long-time anti-vaccine activist, fired all 17 ACIP members and replaced them with many like-minded advisers, whose policies are being challenged in court by several major medical organizations.
BYPASSING TRADITIONAL REVIEW
This week’s sweeping revision of the childhood vaccine schedule did not go through an ACIP review, traditionally a lengthy process that involved outside vaccine and public health experts and CDC staff.
Instead, the agency based the revision on a review by senior HHS staff of vaccine schedules from other developed nations at the urging last month of President Donald Trump, who along with Kennedy, has been pushing to reduce the number of childhood vaccinations.
“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 at the University of Minnesota.
“Our goal is to ensure that policymakers, clinicians, and the public have an accurate understanding of what the data actually show,” he said.
ACIP had begun reviewing evidence suggesting a single dose would be sufficient to prevent most HPV-related cancers, which the World Health Organization backs, but Kennedy disbanded that panel before it could complete its review.
“We’ve been watching the data that’s been accumulating and trying to decide if there’s enough to make the recommendation to reduce the number of doses,” said James Campbell, a professor of pediatrics at the University of Maryland School of Medicine, a former ACIP work group member and vice chair of the American Academy of Pediatrics’ Committee on Infectious Diseases.
He said many nuanced issues still need to be discussed, such as whether a single shot is appropriate for older teens, immunocompromised individuals, boys versus girls, and whether the protection is durable.
Those are “important questions” Campbell said, which he hopes the independent review will help answer.
Currently, the AAP recommends two doses of HPV vaccine for children aged 9-12, or three doses for teens who start the series after age 15.
PROJECT REVIEWS OTHER VACCINE CHANGES
Merck’s Gardasil, the only U.S.-licensed HPV vaccine, is approved based on two or three doses.
Merck said in a statement that in recent prior discussions, the U.S. Food and Drug Administration raised concern that a single-dose regimen may be less effective or less durable and clinical trials would be needed.
The drugmaker said it received similar feedback from European regulators and noted that most developed countries in the European Union, including Denmark, which HHS has used as a model for its vaccine changes, do not recommend it.
Merck recorded $2.4 billion in U.S. Gardasil sales in 2024.
The Vaccine Integrity Project last year published a review of recommendations for flu, COVID-19 and RSV shots, and recently released a review of evidence for the use of hepatitis B vaccines. The longstanding guidance that all newborns receive that inoculation was rescinded by HHS last month.
The Vaccine Integrity Project is supported by the Alumbra Innovations Foundation established by philanthropist Christy Walton and accepts no pharmaceutical industry funding, Osterholm said.
(Reporting by Julie SteenhuysenEditing by Bill Berkrot)
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