What we're covering
• Today’s meeting: Vaccine advisers to the US Centers for Disease Control and Prevention are meeting again today. They voted in favor of a major change to the childhood vaccine schedule.
• On the schedule: The panel recommended abandoning universal hepatitis B vaccination for newborns in the US. Later, the discussion will turn to the vaccine schedule, according to an updated agenda.
• About the panel: The members of the committee were handpicked by US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, after he abruptly fired the 17 sitting members this year.
ACIP votes to abandon universal hepatitis B vaccination for newborns
The US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices appointed by HHS Secretary Robert F. Kennedy Jr. has voted to abandon universal hepatitis B vaccination for newborns.
Eight members voted yes, three voted no for the first vote:
For infants born to HBsAg-negative women: ACIP recommends individual-based decision- making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. (1) Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age. Y/N
CDC hepatitis expert: US, Denmark are not “peer nations” when it comes to health
Friday’s meeting of the CDC’s outside vaccine advisers includes a scheduled presentation comparing the US vaccination schedule to that of Denmark.
It’s set to be delivered by the US Food and Drug Administration’s Dr. Tracy Beth Hoeg, who said of a planned vote to remove a universal newborn dose recommendation for the hepatitis B vaccine: “I think this is a very positive … vote, one that brings us in line with peer nations to not recommend giving the hepatitis B vaccine routinely at birth.”
Dr. Adam Langer, the CDC’s hepatitis B expert, who’s worked for the public health agency for almost 20 years, took issue with the comparison Friday morning.
“The United States is a unique country,” Langer began. Of Denmark, he pointed out, “the entire country has 6 million people. The population of New York City alone is 8 million people.”
Other differences cited by Langer:
• More than 95% of pregnant women in Denmark are screened for hepatitis B, “far higher than the number in the United States.”
• Prenatal care in Denmark is free “for both citizens and refugee or asylum seekers in Denmark. We all know this is not the case in the United States.”
• Denmark has a national health registry that compiles health information at the individual level; “the US does not have that, and I imagine that our privacy culture would not permit us to ever have something like that.”
• In Denmark, pregnant women who test positive for hepatitis B virus are followed up with, along with all infants, to ensure they’re vaccinated and tested for the virus, whereas in the US, “many of these infants are lost to follow-up as soon as they leave the hospital.”
“Denmark and, for that matter, virtually all other high-income countries are not really peer nations,” Langer concluded.
The best comparison, he said, might be Canada, where right now recommendations for hepatitis B vaccination are developed at the local level. But, Langer said, “recent studies in Canada have shown that a universal hepatitis B birth dose is going to be needed to achieve elimination” of the virus in Canada, “which is exactly what we learned here in the United States decades ago.”
“Let’s talk about apples to apples, not apples to oranges,” Langer said.
Hoeg responded that the level of risk for babies isn’t different because of differences in health-care systems.
“Fourth iteration of votes in 96 hours:” Disputes among ACIP members continue over hepatitis B vote
After two delays of a potentially seismic vote to remove the universal recommendation for a newborn dose of the lifesaving hepatitis B vaccine, debate continued among CDC vaccine advisory committee members Friday morning over what to vote on.
“I consider that this fourth iteration of votes in 96 hours is still incredibly problematic,” said ACIP member Dr. Joseph Hibbeln, who’d protested the voting language chaos Thursday as well.
The committee delayed Thursday’s scheduled vote on the vaccine to Friday morning, after another delay from its September meeting.
The extra time didn’t appear to settle internal disputes, with ACIP member Dr. Cody Meissner saying the second vote “is kind of making things up,” referring to a proposed recommendation that
babies have their blood tested to assess their immunity before determining the need for additional vaccine doses.
The current voting language says:
There will be no change to the vaccination recommendation for infants born to women who test HBsAg-positive or have an unknown HBsAg status – existing recommendation remains the same.
VOTE 1 For infants born to HBsAg-negative women: ACIP recommends individual-based decision- making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. (1) Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age. Y/N
VOTE 2 When evaluating the need for a subsequent HBV vaccine dose in children, parents should consult with health care providers to determine if a post-vaccination anti-HBs serology testing should be offered. Serology results should determine whether the established protective anti- HBs titer threshold of ≥10 mIU/mL has been achieved. The cost of this testing should be covered by insurance. Y/N
(1) Parents and health care providers should also consider whether there are risks, for example, such as a household member is HBsAg-positive or when there is frequent contact with persons who have emigrated from areas where Hepatitis B is common.
"This is unconscionable": Some vaccine advisers say they're being asked to vote on recommendations without evidence or debate
During discussions before the vote, CDC Advisory Committee on Immunization Practices member Dr. Joseph Hibbeln, a psychiatrist, objected to a proposed recommendation that babies who don’t get a dose of the hepatitis B vaccine at birth should start the series “no earlier” than 2 months of age.
“This specific point is the reason why we tabled this issue for three months to more fully discuss it,” Hibbeln said.
“However, we have still not had any information or science presented or discussed with regards to this issue of before or after two months of age. This is unconscionable,” he added.
Hibbeln and Dr. Cody Meissner, a pediatrician at Dartmouth, also objected to the idea that babies should get a blood test after the first dose of the vaccine, before more shots in the series are given.
“This has not been debated. No information was presented on this issue. And you know the full series of doses is required to achieve 95% efficacy, so in addition to this not being discussed, there has been no data presented that this plan would actually work,” Hibbeln added.
“What is the advantage of giving a dose starting at two months? Rather than at one month? We’ll lose at least some of the protective effect. And I don’t think there’s any reduction in risk,” Meissner said. “So it simply would be hard for me to accept.
“Vote two is kind of making things up,” said Meissner, referring to the recommendation that children get a blood test before they get more doses of the hepatitis B vaccine. “I mean, it’s like never-never land.”
Vaccine experts Offit, Hotez declined invitations to ACIP, say committee is now "a font of misinformation”
Kicking off Friday’s meeting of the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, Vice Chair Dr. Robert Malone said the group had invited vaccine experts Dr. Paul Offit and Dr. Peter Hotez to “present and discuss their perspectives” on the childhood immunization schedule, and that they’d declined.
Aaron Siri, an attorney with close ties to US Department of Health and Human Services Secretary Robert F. Kennedy Jr., is scheduled to make a presentation on the vaccine schedule Friday morning.
Offit, a vaccine scientist at Children’s Hospital of Philadelphia and previous ACIP member, told CNN he’d declined because he “didn’t see the point of presenting to a group that is a parody of a public health agency.
“They have already made up their mind that vaccines were unnecessarily dangerous,” Offit said. “They’re a font of misinformation.”
Hotez, dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston, said that he declined “because ACIP appears to have shifted its mission away from science and evidence-based medicine.”
“I’m always happy to discuss the science of vaccines with individuals or groups who are committed to truth and genuine intellectual inquiry,” he said.
The American Academy of Pediatrics has also declined to participate in ACIP meetings this year after Kennedy dismissed the entire panel in June and reconstituted it with ideological allies. “It is no longer a credible process,” the academy said in June.
Dr. Cody Meissner, the ACIP member most respected among outside public health experts for his vaccine expertise – and who frequently finds himself at odds with other current ACIP members – criticized the AAP Friday morning for declining to participate.
“My concern is that by not participating, the academy will be seen as more focused on making a political statement, rather than focusing on the health of children,” Meissner said.
“Along with other advances in public health, such as clean drinking water and pasteurization, immunizations are one of the most important medical interventions available,” Meissner went on. “Vaccines are a standard of care, and pediatricians should be part of these discussions.”
Dr. James Campbell, vice chair of the AAP Committee on Infectious Diseases, told CNN Friday the academy “did not protest the meeting, and we never have. As ACIP continues its work this week, it is essential that deliberations are firmly grounded in rigorous, independent, evidence-based science. The committee’s role in safeguarding public health depends on transparent review processes and policy decisions that reflect high-quality data and established scientific consensus. Recent discussions have increasingly reflected departures from that standard. When evidence and science returns to the process, so will the AAP.”
What to know about hepatitis B
Hepatitis B is a liver infection caused by a virus.
After an acute hepatitis B infection, many adults clear the virus. But acute infection can lead to chronic hepatitis B, which is linked to increased risk of liver cancer, organ failure and cirrhosis, or scarring over the liver. People with chronic hepatitis B are 70% to 85% more likely to die early.
Infants and children who are infected with hepatitis B are more likely to develop chronic disease, including about 90% of infants and 30% of children ages 1 to 5.
How is hepatitis B spread?
The hepatitis B virus is extremely infectious. It is transmitted when blood, semen or another body fluid from a person infected with the virus enters the body of someone who’s not infected.
Certain medical conditions, behaviors and other factors increase the risk of acquiring hepatitis B — including injecting drugs and sexual activity — but anyone can get it. The virus can also be passed easily from mother to child during either a vaginal delivery or a C-section.
How common is hepatitis B?
Many people with hepatitis B do not have symptoms, and more than half may not be aware of their infection.
The latest data from the CDC shows that there were about 2,200 newly reported cases of acute hepatitis B in 2023, but estimates suggest that the actual number of cases was more than six times higher: closer to 14,400.
The CDC also estimates that about 640,000 adults in the US have chronic hepatitis B.
Globally, the World Health Organization estimates that 254 million people were living with chronic hepatitis B infection, with about 1.2 million new infections each year.
Can hepatitis B be treated?
There is no treatment for acute hepatitis B, but there are some medications that can be used to treat chronic cases. Treatment for chronic hepatitis B can be lifelong, and there is no cure.
How can hepatitis B be prevented?
The best way to prevent hepatitis B infection is vaccination.
Most people who have hepatitis B were infected as infants or young children when their immune systems were not fully developed. Currently, it is recommended that all infants get vaccinated shortly after birth.
CDC advisers to reconvene for crucial hepatitis B vaccine vote
After a day punctuated by frustration and confusion, the CDC vaccine advisers will reconvene for the second session of the two-day meetings.
On today’s agenda: the crucial vote on hepatitis B vaccine recommendations for newborns and infants, as well as discussions of the vaccine schedule for children and teens.
The Hepatitis B Foundation said it was “deeply disappointed and extremely concerned” about Thursday’s discussion. “Overall, the meeting lacked transparency, with many of the presentations showing one-sided data, and several points made by Committee members clearly showed that they have a very specific agenda.”
The most recent version of the voting language indicates the CDC advisers will consider three issues:
- VOTE 1: Whether to recommend a birth dose of hepatitis B vaccine and immunoglobulin for infants born to women who test positive for the virus, and individual decision-making in consultation with a health care provider for women who test negative. The vaccine would be suggested no earlier than 2 months of age for infants who don’t get a dose at birth.
- VOTE 2: Whether to reaffirm the current standard recommending a birth dose of vaccine and immunoglobulin for children of women whose hepatitis B status is unknown.
- VOTE 3: Whether to recommend that parents consult with health care providers when deciding whether children need hepatitis B tests before subsequent vaccine doses.
