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A federal vaccine advisory committee gathered in Atlanta on Thursday to reassess the longstanding guidance regarding the hepatitis B vaccination for newborns. This meeting reflects a pivotal moment in public health as the committee evaluates whether the vaccine should continue to be administered on the day of birth.
For many years, it has been a standard practice for newborns to receive the hepatitis B vaccine immediately after birth, a strategy credited with preventing numerous cases of the liver infection. The policy has been hailed as a public health triumph, significantly reducing the incidence of the disease.
However, the committee, led by U.S. Health Secretary Robert F. Kennedy Jr., is deliberating a possible shift in approach. They are considering whether to recommend the birth vaccine exclusively for infants whose mothers have tested positive for the virus. This potential change would revisit a strategy set aside over 30 years ago. For infants whose mothers test negative, the decision would rest with the parents and healthcare providers.
Committee member Vicky Pebsworth highlighted that a dedicated work group had been assigned in September to scrutinize the necessity of the birth dose for babies born to mothers who test negative for hepatitis B. “We need to address stakeholder and parent dissatisfaction with the current recommendation,” she noted.
“We need to address stakeholder and parent dissatisfaction” with the current recommendation, she said.
The committee makes recommendations to the director of the Centers for Disease Control and Prevention on how already approved vaccines should be used. CDC directors almost always adopted the committee’s recommendations, which were widely heeded by doctors and guide vaccination programs. But the agency currently has no director, leaving acting director Jim O’Neill to decide.
Kennedy, a leading anti-vaccine activist before he became the nation’s top health official, fired the entire 17-member panel earlier this year and replaced it with a group that includes several anti-vaccine voices.
The panel has made several decisions that angered major medical groups.
At a June meeting, it recommended that a preservative called thimerosal be removed from doses of flu vaccine even though some members acknowledged there was no proof it was causing harm.
In September, it recommended new restrictions on a combination shot that protects against chickenpox, measles, mumps and rubella. The panel also took the unprecedented step of not recommending COVID-19 vaccinations, even for high-risk populations such as seniors, and instead making it a matter of personal choice.
Several doctors groups said the changes were not based on good evidence, and advised doctors and patients to follow guidance that was previously in place.
They renewed some of that criticism. Dr. Jason M. Goldman, president of the American College of Physicians, commented during the meeting, calling it “political theater” and adding that “you are basing this on concerns of individuals who don’t want the vaccine.”
Some committee members argued that safety studies in the past were limited and it’s possible that larger additional studies could uncover a problem with the birth dose. But two other committee members — Dr. Joseph Hibbeln and Dr. Cody Meissner — saw no documented evidence of harm from the birth doses and wondered whether the concern behind the discussion is just, as Hibbeln said, “speculation.”
Hepatitis B is a serious liver infection that, for most people, lasts less than six months. But for some, especially infants and children, it can become a long-lasting problem that can lead to liver failure, liver cancer and scarring called cirrhosis.
In adults, the virus is spread through sex or through sharing needles during injection drug use.
But it can also be passed from an infected mother to a baby. As many as 90% of infants who contract hepatitis B go on to have chronic infections, meaning their immune systems don’t completely clear the virus.
In 1991, the committee recommended an initial dose of hepatitis B vaccine at birth. Over about 30 years, cases among children fell from about 18,000 per year to about 2,200.
But members of Kennedy’s committee have voiced discomfort with vaccinating all newborns.
Cynthia Nevison, an autism and environmental researcher, presented at the meeting. Nevison has written opinion pieces published by Children’s Health Defense, an anti-vaccine advocacy organization Kennedy previously led. She also co-authored a 2021 article in the Journal of Autism and Developmental Disorders that the publication retracted after concerns were raised about the paper’s methodology and about nondisclosed ties between the authors and anti-vaccine groups.
Another presenter was Mark Blaxill, a co-author of the retracted paper, who spoke about vaccine safety.
In the past, committee meetings have relied on presentations by the CDC scientists involved in tracking vaccine-preventable diseases and assessing vaccine safety. The agenda for this meeting listed no CDC scientists, but rather featured a prolonged public airing of anti-vaccine theories that most scientists have deemed as discredited.
Kennedy is a lawyer by training. Aaron Siri, a lawyer who worked with Kennedy to sue vaccine makers, is listed as a presenter on Friday on the topic of the immunization schedule for U.S. children.
The current guidance advises a dose within 24 hours of birth for all medically stable infants who weigh at least 4.4 pounds (2 kilograms), plus follow-up shots to be given at about 1 month and 6 months. The committee is expected to vote on language that says when a family decides not to get a birth dose, then the vaccination series should begin when the child is 2 months old.
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