CDC advisers vote in support of major change to childhood vaccination

Senator Bill Cassidy said the acting CDC director should not sign off on a new hepatitis B vaccine recommendation from the agency’s vaccine advisers.

“As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake,” Cassidy, a Republican from Louisiana, posted on the social media platform X.

“The hepatitis B vaccine is safe and effective. The birth dose is a recommendation, NOT a mandate. Before the birth dose was recommended, 20,000 newborns a year were infected with hepatitis B. Now, it’s fewer than 20,” noted Cassidy.

“Ending the recommendation for newborns makes it more likely the number of cases will begin to increase again. This makes America sicker. Acting CDC Director O’Neill should not sign these new recommendations and instead retain the current, evidence-based approach.”

Cassidy cast the deciding vote that allowed Robert F. Kennedy, Jr., who has talked about the harms of vaccines for decades, to become secretary of the US Department of Health and Human Services. As secretary, he fired members of the CDC committee and replaced them with his own picks.

The CDC makes the final decision on vaccine recommendations, but typically aligns with its advisory panel’s vote. O’Neill is serving as CDC’s acting director since Director Dr. Susan Monarez was ousted from the role.

Local health departments across the United States are bracing for the potential public health impact of abandoning universal hepatitis B vaccinations for newborns.

Friday’s ACIP vote will impact health departments and the communities they serve, said Lori Tremmel Freeman, chief executive officer for the National Association of County and City Health Officials.

“This is a preventative vaccination that we’re talking about,” Freeman said.

More than 6 million hepatitis B illnesses were prevented by routine childhood immunizations between 1994, when the CDC’s Vaccines for Children Program launched, and 2023, according to a CDC study published last year.

There is also growing concern that the ACIP vote possibly may impact access to vaccines for families who want to vaccinate their children.

“We know that up to two-thirds of pediatric hepatitis B cases happen in cases where a mom initially tested negatively and then the virus was later transmitted through the household or the community,” Freeman said.

“There are cases of hepatitis out there, and we have to keep up the testing and vaccinations, because it can sit silently in a family, in a community, and it can do a lot of damage later on to people. Hepatitis carries with it significant contribution to severe disease, morbidity and mortality — liver diseases, liver cancer, transplants, death.”

Members of CDC's Advisory Committee on Immunization Practices, shown during a meeting on Friday.

The CDC’s Advisory Committee on Immunization Practices has voted to recommend individual decision-making, also called shared clinical decision-making, for parents who want to vaccinate newborns against the hepatitis B virus and who get free vaccines through the Vaccines for Children Program.

They also recommended that if parents served by the VFC program delay a dose of the hepatitis B vaccine at birth, they should wait until at least 2 months of age for the baby’s first dose.

The Vaccines for Children program, or VFC, provides free vaccines to families who wouldn’t otherwise be able to afford them.

The adoption of the VFC resolution also means that these families will be recommended to consider giving kids a blood test to check to see if they’ve developed antibodies to the vaccine before proceeding with additional doses.

Eight members of the committee voted to adopt the resolution, while three members abstained, citing confusion about what they were voting on or the impact it could have.

The members voting yes were Dr. Hillary Blackburn, Dr. Evelyn Griffin, Dr. Robert Malone, Dr. Vicky Pebsworth, Dr. Retsef Levi, Dr. Catherine Stein, Dr. Raymond Pollak and Dr. Kirk Milhoan. The members abstaining were Dr. James Pagano, Dr. Cody Meissner and Dr. Joseph Hibbeln.

A demonstrator holds a sign outside the Center for Disease Control (CDC) headquarters in Atlanta on Thursday.

“Instead of protecting babies, this ACIP vote will lead to preventable hepatitis B infections and future cases of liver cancer,” said Fatima Khan, co-founder of the non-profit parents group Protect Their Future.

“The hepatitis B birth dose is one of the safest, most effective vaccines ever introduced, with decades of data showing it prevents lifelong infection, liver cancer, and early death. There is no scientific basis for delaying it,” Khan said in a statement to CNN.

“This move is driven by politics and ideology, not public health. Babies deserve protection rooted in evidence, not the shifting priorities of political appointees,” Khan said.

The American Academy of Pediatrics said it continues to recommend routine hepatitis B vaccination for all newborns.

“This irresponsible and purposely misleading guidance will lead to more hepatitis B infections in infants and children,” said American Academy of Pediatrics President Dr. Susan J. Kressly. “I want to reassure parents and clinicians that there is no new or concerning information about the hepatitis B vaccine that is prompting this change, nor has children’s risk of contracting hepatitis B changed. Instead, this is the result of a deliberate strategy to sow fear and distrust among families.”

Dr. Jason Goldman, the ACIP liaison from the American College of Physicians, told CNN, “In my opinion, Secretary Kennedy’s vaccine committee is political theater without any concern for true scientific inquiry or evidence review. Their decisions are dangerous and will cause generational harm to our public health system and trust in vaccines.”

Dr. Robert Malone speaks during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Friday in Atlanta, Georgia.

The US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices appointed by HHS Secretary Robert F. Kennedy Jr. has voted in favor of recommending that parents and health care providers consider blood tests for children to assess their immunity to hepatitis B before determining the need for additional vaccine doses.

Six committee members voted yes, four voted no and one abstained. Committee members Dr. Retsef Levi, Dr. Vicky Pebsworth, Dr. Robert Malone, Dr. James Pagano, Dr. Evelyn Griffin and Dr. Kirk Milhoan voted yes. Dr. Cody Meissner, Dr. Joseph Hibbeln, Dr. Raymond Pollak and Dr. Hillary Blackburn voted no. Dr. Catherine Stein abstained.

The language of the second vote was:

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

Committee member Dr. Cody Meissner, shown during a meeting of the CDC's Advisory Committee on Immunization Practices at the CDC on Friday.

Dr. Cody Meissner, among the three vaccine advisory committee members who voted against removing the universal hepatitis B newborn dose recommendation Friday, told his fellow panelists that “we are doing harm by changing this wording.”

He was joined in his “no” vote by Dr. Raymond Pollak and Dr.
Joseph Hibbeln, the latter echoing Meissner’s language in his own comments.

“This has a great potential to cause harm, and I simply hope that the committee will accept its responsibility when this harm is caused,” Hibbeln said.

The CDC Advisory Committee on Immunization Practices meets in Atlanta on Friday.

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.

According to the CDC, the United States is the only country that has ever moved from giving all babies a dose of the hepatitis B vaccine at birth to delaying the shot.

Eight members voted yes, three voted no for the first vote. Committee members Dr. Catherine Stein, Dr. Retsef Levi, Dr. Vicky Pebsworth, Dr. Robert Malone, Dr. Hillary Blackburn, Dr. James Pagano, Dr. Evelyn Griffin and Dr. Kirk Milhoan voted yes. Dr. Cody Meissner, Dr. Joseph Hibbeln and Dr. Raymond Pollak voted no.

The voting language was:

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

(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.

The language calls for individual-based decision-making, also known as shared clinical decision-making, which generally means consultation with a doctor or other health care provider and possibly a prescription before vaccination. This requirement can make it more complicated for patients to get vaccines.

The second part of the vote means that for those not receiving a dose at birth, there would be a delay for two months or longer, leaving newborns and children vulnerable to hepatitis B infection.

The US Centers for Disease Control and Prevention makes the final recommendation, but typically aligns with the advisory panel’s vote. Deputy Health and Human Services Secretary Jim O’Neill is serving as acting CDC director since Director Dr. Susan Monarez was ousted from the role.

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.

Members of the CDC's Advisory Committee On Immunization Practices at the US Centers for Disease Control and Prevention headquarters in Atlanta on Thursday.

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.

Committee member Dr. Joseph Hibbeln speaks during a meeting of the Advisory Committee on Immunization Practices at the CDC in September.

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.”

Dr. Peter Hotez speaks at The Texas Tribune Festival in Austin, Texas, in September 2022.

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.”

An image of the hepatitis B virus taken with transmission electron microscopy.

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.

Dr. Robert Malone speaks during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) at CDC Headquarters in Atlanta, Georgia, on Thursday.

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: