A key vaccine panel at the Centers for Disease Control and Prevention voted 8-3 to nix a recommendation that all newborns be given a first dose of hepatitis B vaccine.
The Friday vote, which came after the panel heard presentations from vaccine skeptics, does away with guidance that has been in place since 1991. Scientists have credited it with helping drive down rates of hepatitis B infection, which can lead to liver damage, cancer and death.
The Advisory Committee on Immunization Practices, or ACIP, recommended that if an infant’s mother tests negative for hepatitis B, parents should consult a doctor about whether the baby needs an early vaccine dose. ACIP also suggested that infants who skip the birth dose shouldn’t receive their first dose until they are at least two months of age.
The recommendation from the committee—which was remade by Health Secretary Robert F. Kennedy Jr. earlier this year after he pushed out all the previous members—must be endorsed by the acting CDC director before it goes into effect.
Proponents of the change argued that not enough is known about potential risks of the vaccine and that most babies aren’t likely to contract the virus. One panel member, Dr. Evelyn Griffin, said the vaccine could lead to autoimmune conditions, while acknowledging no high-quality studies had shown that.
“Patients are unaware that their babies are getting a lot of interventions in the first few hours of life,” said Griffin, an obstetrician who voted for the change. “Parental rights are violated.”
Critics of the committee’s move argued that the safety of the birth dose is backed by randomized, controlled studies and more than three decades of use, with the nation’s vaccine-safety surveillance systems finding no unusual harms.
Panel member Dr. Joseph Hibbeln, a psychiatrist, voted against the change, saying the committee hadn’t reviewed science on why the recommendation should be two months. “This is unconscionable,” he said. “No rational science or discussion has been presented.”
Public-health experts have warned against delaying the vaccine or only immunizing the babies of infected women at birth. They note that because the hepatitis B test is typically done in the first trimester, women can still become infected later in pregnancy or some might not get tested at all. They also say that, beyond maternal transmission, the virus is often spread through shared surfaces such as washcloths and toothbrushes.
“The birth dose is critical to preventing hepatitis B, which is the leading cause of liver cancer worldwide,” said Chari Cohen, president of the Hepatitis B Foundation. “It is not a virus you want your baby to have.”
The committee heard presentations Thursday from ACIP member Vicky Pebsworth, a board member at the National Vaccine Information Center, which advocates against vaccines; CDC contractor Cynthia Nevison, a climate researcher who has worked with the antivaccine group SafeMinds and written for Children’s Health Defense, the nonprofit founded by Kennedy that has questioned vaccines; and Mark Blaxill, a longtime antivaccine activist who now works at the CDC.
The newly appointed acting director of the drugs division at the Food and Drug Administration, Dr. Tracy Beth Hoeg, suggested to the panel that hepatitis B vaccines shouldn’t be given to children at all. She pointed to other countries including Denmark that don’t recommend the hepatitis B vaccine for all newborns. CDC scientist Adam Langer said many of those other countries including Denmark have national health systems, in which it is easier to screen and track infected mothers.
Blaxill argued that vaccine-injury claims paid out by the National Vaccine Injury Compensation Program showed that the hepatitis B vaccine causes harm. But the federal government has said that such settlements shouldn’t be used to draw conclusions about vaccine safety.
Dr. Jason Goldman, president of the American College of Physicians, who has been a liaison to ACIP for more than a decade, accused the committee’s leadership of “promoting an antivaccine agenda.”
“Stop cherry-picking the data by individuals who do not have the scientific evidence and data-driven background to make those presentations,” he said.
The panel voted on the hepatitis B recommendation Friday after delaying the vote initially scheduled for Thursday, in an effort to give panel members time to consider the exact language on which they were voting. The CDC waited until hours before the meeting began on Thursday to post the vote language—but then changed the wording again, causing confusion for panel members and giving outside groups little time to opine on the potential impacts.
The ACIP’s recommendations guide what vaccines are covered at no cost to patients by many insurers and federal health programs. Private insurers in some states may drop coverage for the birth dose for some babies, said vaccine attorney Richard Hughes. A Centers for Medicare and Medicaid Services representative said the birth dose would continue to be covered by federal insurance programs.
The committee also voted 6-4, with one abstention, to recommend that parents consider antibody testing for children after a dose of hepatitis B vaccine to determine whether the child needs further doses, and that insurers cover those tests. Hepatitis B vaccines are typically given as a series of three doses.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.