Author: Julie Steenhuisen
CHICAGO, Jan 8 (Reuters) – An independent vaccine advisory group said on Thursday it would review the scientific evidence for a vaccine used to prevent cervical and other cancers that U.S. health officials said this week can only be administered in a single dose, contrary to the FDA-approved injectable vaccine.
The change by the CDC sidesteps the traditional U.S. review process.
The new schedule recommends that U.S. children receive one dose of the human papillomavirus (HPV) vaccine at age 11, rather than the recommended two or three doses, which vary depending on the age at which shots are started.
The University of Minnesota’s Vaccine Integrity Project was established last year to conduct an independent review of vaccine evidence, similar to one previously conducted by the CDC’s Advisory Committee on Immunization Practices.
In June, Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccination campaigner, fired all 17 ACIP members and replaced them with a host of like-minded advisers whose policies have been challenged in court by several major medical groups.
Bypass traditional censorship
This week’s sweeping revision of the childhood vaccine schedule has not been reviewed by ACIP, which has traditionally been a lengthy process involving outside vaccine and public health experts as well as CDC staff.
Instead, the agency’s revisions are based on a review of vaccination programs in other developed countries by senior staff at the U.S. Department of Health and Human Services at the urging of President Donald Trump last month, who along with John F. Kennedy have pushed to reduce the number of childhood vaccinations.
“While we are not ACIP, we are trying to fill gaps in scientific information,” 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 understand exactly what the data actually shows,” he said.
ACIP had begun reviewing evidence that a single dose was sufficient to prevent most HPV-related cancers, a finding supported by the World Health Organization, but Kennedy disbanded the group before completing its review.
“We’ve been looking at the data that’s accumulating and trying to determine if there’s enough data to make a 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 task force member and vice chair of the American Academy of Pediatrics’ Committee on Infectious Diseases.
Many delicate issues still need to be discussed, he said, such as whether a single shot is appropriate for older teenagers, the immunocompromised, boys versus girls, and whether protection is long-lasting.
Campbell said these were “important questions” and he hoped the independent review would help answer them.
Currently, the AAP recommends two doses of HPV vaccine for children ages 9-12, or three doses for adolescents starting vaccination after age 15.
Project reviews other vaccine changes
Merck & Co.’s Gardasil is the only licensed HPV vaccine in the United States, approved on a two-dose basis. The drugmaker did not immediately respond to a request for comment on the changes or the decision-making process, but said there was insufficient data for the U.S. Food and Drug Administration to approve the shot as a single-dose regimen.
Merck’s Gardasil sales in the United States will reach $2.4 billion in 2024.
The Vaccine Integrity Project last year released a review of vaccination recommendations for influenza, COVID-19 and RSV, and more recently a review of the evidence for the use of the hepatitis B vaccine. The U.S. Department of Health and Human Services (HHS) last month rescinded longstanding guidance that all newborns receive vaccinations.
Osterholm said the Vaccine Integrity Project, which is supported by the Alumbra Innovation Foundation established by philanthropist Christy Walton, does not receive funding from the pharmaceutical industry.
(Reporting by Julie Steenhuisen; Editing by Bill Berkrot)
