Vaccine advisory panel votes to end universal newborn hep B shot recommendation

A federal advisory panel with power over vaccine policy has voted to stop recommending a universal newborn shot to prevent the hepatitis B virus, which causes liver disease — a major shakeup to the childhood vaccine schedule under Health Secretary Robert F. Kennedy Jr.

The ​​Advisory Committee on Immunization Practices, or ACIP, voted Friday to remove its longstanding recommendation that all infants be given a shot of the hepatitis B vaccine within 24 hours of birth.

The panel instead agreed to only recommend a newborn dose to infants of a birthing parent who has tested positive for hep B or whose infection status is unknown — a targeted approach on a high-risk group that was tried decades ago. Medical groups and public health experts have repeatedly warned it will not catch all infections.

The panel also recommended that parents who still want the newborn hep B shot should now participate in “individual-based decision-making” with a health care provider. They recommended that parents who decline the newborn shot delay vaccination until the child is at least two months old — a delayed timeframe that medical groups say is not rooted in science-based evidence. The panel also suggested that parents consult with a health provider over whether to complete the multi-dose series at all.

While the recommendations appear to allow parents to continue getting the hep B vaccine for their kids, the move could cause confusion among families and logistical barriers for health providers. Medical experts also worry it will increase hesitancy among parents about childhood vaccines amid misinformation messaging from the federal government.

“Parents are going to do what they think is the best for their children, and if they think that there is any risk for their child in getting some of these vaccines, or diseases that they don’t know or understand or have seen in the real world, then that hesitancy is only going to increase,” said Michael Ninburg, former president of the World Hepatitis Alliance, during a news briefing earlier this week with reporters. He added: “The sowing of doubt is probably the most dangerous part.”

The ACIP panel, which met in Atlanta over two days, delayed its votes by a day after members were confused about the scope of what they were voting on. A similar delay occurred when the panel met in September. Members ultimately based their votes in part on claims made by outside speakers, some with anti-vaccine views, that the number of hep B infections are overblown and the vaccine is not as safe as it is perceived to be. But extensive analysis of the risks associated with the virus and the safety of the vaccine contradicts those assertions, and multiple medical groups criticized the presentations. Even some ACIP members questioned the data presented and the suggestion that some parents wait two months for a first shot.

“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,” Dr. Joseph Hibbeln. “This is unconscionable. How can we go forward when this is a specific issue that was supposed to be identified?”

ACIP member Dr. Cody Meissner added: “To make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis B.”

The changes alter the childhood vaccine schedule, the series of shots given gradually to children in the United States to help protect them against preventable diseases that once caused widespread illness and death. The consequences, doctors and medical groups warn, will be more infected infants — a public health ripple effect that could create a new generation of unnecessary chronic illness, cancer and death.

“This would be a major blow to pediatric health in the United States,” said Emily R. Smith, interim chair of the Department of Global Health at George Washington University’s Milken Institute School of Public Health, who noted that America’s universal hep B birth shot has been a point of pride in the global health community because of its success. (The World Health Organization also recommends the birth dose, as do many countries.) She added: “It is within our power to have zero children with hepatitis B living in this country.”

Some ACIP members expressed support for ending the universal birth dose to give parents more choice in their children’s health. But Smith pointed out that parents can already decline vaccinations. Instead, such changes could make it harder for parents who want to vaccinate their children to do so as they navigate more fractured rules within the medical system. Vaccine experts have raised questions about disruptions to other vaccine shots that are combined with subsequent hep B doses and future out-of-pocket costs. For now, federal officials claim the changes won’t create new costs for parents, and many private insurers have committed to keep covering shots through the end of 2026.

“The point of public health is to make sure that everyone gets this coverage. And that’s what a universal birth dose does, is make sure that as a community we’re all protected,” she said. “That’s the value of having a universal policy versus ‘you can get it if you want to’ policy … fewer people have access to it for a variety of different reasons, which means we have more cases, which means that all of our kids are at higher risk.”

ACIP is housed under the CDC and makes vaccine recommendations that have determined whether insurance companies and federal programs will pay for shots. Many states adopt their vaccine policies based on the panel’s recommendations, though some have begun reconsidering their laws and regulations to bypass this system, citing concerns over how the new panel is making decisions. 

The hep B vaccine is typically a highly effective three-dose series administered during early infancy: Up to 90 percent of newborns infected with hepatitis B develop chronic disease. But when the first vaccine shot is given within 24 hours of birth, it is also up to 90 percent effective in preventing perinatal infection. Since the addition of a universal newborn shot to the childhood vaccine schedule in the early 1990s, there’s been a 95 percent reduction in infant infections and an estimated 90,000 deaths prevented.

It is estimated that a single year of delaying the shot by two months for babies born to a birthing parent whose hep B status is unknown, could lead to more than 1,400 infections, 300 cases of liver cancer and more than 480 related deaths. 

But the shot has become a target of anti-vaccine activists, who question why it is needed during infancy if many of the reported infections come from sexual activity and intravenous drug use. That argument lacks critical context: Some hep B infections are spread through a birthing parent during delivery who is infected with the virus — and yet another portion of infections are spread through unknown circumstances. Some reported cases have included day care settings and playgrounds.

Not all parents-to-be are tested for hepatitis B during their pregnancy for a mix of reasons around limited access to prenatal care — as many as half a million people each year. The universal birth shot ensures fewer children fall through the cracks of the American health care system.

Michaela Jackson, program director for prevention policy at the Hepatitis B Foundation, noted that before a universal newborn vaccine, only half of children who were later infected were exposed through the birth parent.

“When we’re talking about screening mothers, it sounds very nice on paper, but the reality is, fathers can have hepatitis B, caregivers can have hepatitis B, and they have no idea that they’re living with it because we do not do a fantastic job of testing in the United States for it yet,” she said.

The panel discussed the need for closing the gap in screening pregnant people for hep B — but it’s a barrier within the health care system that goes beyond the scope of the panel’s abilities. At another point, some panel members openly blamed immigrants for the existing cases of hep B in the United States, which are estimated to impact up to 2.4 million people, including non-immigrants.

Multiple medical groups with representatives at the meeting slammed the panel for debating a vaccine delay without new safety research, and repeatedly requested more data. Several noted that informed consent between doctor and patient is already a regular occurrence

“How can this committee justify removing a well established, successful and safe prevention strategy that is going to protect the most vulnerable infants when the proper measures to identify those infants who are at risk are not in place?” asked Dr. Flor Muñoz with the Infectious Diseases Society of America.

Dr. Jason Goldman, president of the American College of Physicians, later added: “This vote is an unnecessary solution looking to find a problem to solve. It will not fix your concerns of informed consent, but only endanger children and increase risk of death for millions.”

ACIP’s actions come amid growing vaccine hesitancy that’s being promoted by Kennedy, an anti-vaccine activist who has based his political messaging on government mistrust. Kennedy has continued to promote misinformation about vaccines without science-based evidence. In June, he abruptly fired all 17 ACIP panelists — people with extensive experience in vaccine policy including virology and immunology — and replaced them with new members, some of whom have embraced conspiracy theories about vaccines. 

This politicization has prompted medical organizations, which continue to recommend the newborn hep B shot, to distance themselves from ACIP. The new members in recent months have scaled back recommendations for COVID-19 vaccination and a combination measles shot, among other changes. Republican Sen. Bill Cassidy of Louisiana, a doctor who has garnered public attention for being a key vote in confirming Kennedy’s appointment, said ahead of the meeting that the panel is “totally discredited” and members “are not protecting children.”

The votes signify more vaccine policy changes could be coming under Kennedy. Last month, the secretary directed the CDC to update its website to claim, without evidence, that vaccines cause autism. That follows his department’s guidance in the fall to warn pregnant people that taking over-the-counter pain relief medication could cause autism — another assertion that has been debunked. Officials at the Food and Drug Administration, which report to Kennedy, have also indicated plans to revamp the review and oversight of vaccines. 

Kennedy, who has defended these actions through press interviews, news releases and social media posts, has indicated an interest in further examining the childhood vaccine schedule — a topic that ACIP is scheduled to discuss again Friday.