MW CDC group no longer recommends hepatitis B shot for newborns. This is what it means.

By Jaimy Lee

The Advisory Committee on Immunization Practices also changed the guidance for which babies should get the vaccine

Robert Malone speaks during the meeting of the CDC's Advisory Committee on Immunization Practices on Friday in Atlanta.

A CDC committee's decision to change longstanding hepatitis B vaccine recommendations for babies is the latest sign that vaccine skeptics are reshaping policies that aim to prevent the spread of infectious diseases.

The CDC's Advisory Committee on Immunization Practices no longer recommends that all newborns get the first dose of the vaccine within 24 hours of birth. That was always a recommendation, not a requirement. The committee is instead recommending what it calls "individual-based decision-making" for babies born to HBV-negative mothers when they are at least 2 months old.

The committee is currently made up of people who largely share similar views on vaccines as Health and Human Services Secretary Robert F. Kennedy Jr., who fired all the members of the panel in June.

"We are doing harm by changing this wording," said Cody Meissner, a professor of pediatrics at the Geisel School of Medicine at Dartmouth College and current ACIP member.

The vote was delayed twice, first in September and again on Thursday.

Over the course of the chaotic and theatrical meeting, which began Thursday, the committee members sparred with each other, members of the public and other medical experts. Many of the discussion points appeared to air COVID-era worries about vaccines rather than in-depth concerns about the safety and effectiveness of the hepatitis B vaccine.

Panelists repeatedly cited examples of children being asked to leave pediatric practices or schools as a result of their vaccine status and questioned whether families were able to practice "informed consent."

A primary concern about the universal birth dose of the hepatitis B vaccine is that babies shouldn't bear the responsibility for adults who contract the disease. But getting infected before the age of 5 increases the risk of chronic hepatitis B, which is the leading cause of liver cancer, cirrhosis and liver transplants, although not all people who contract the virus develop a chronic version of the disease.

The first hepatitis B vaccine was approved in the 1980s and has been recommended for newborns at birth since the early 1990s. Hepatitis B is a viral infection that can be transmitted to babies during birth if the mother is infected or by blood if an infected caregiver or child has a cut, however small. It is also spread via semen and other bodily fluids or by sharing needles.

There were two votes on the new recommendation, neither of which were unanimous. The next step is for acting CDC director Jim O'Neill to sign off on the new recommendations.

The American Academy of Pediatrics criticized the decision, saying the "irresponsible and purposely misleading guidance will lead to more hepatitis B infections in infants and children." It still recommends that all newborns get the first dose of the vaccine within 24 hours of birth.

More babies are expected to get hepatitis B as a result of the CDC committee's decision to change the recommendations for newborns.

There are at least two research papers that model the impact of the decision, though one is much more conservative than the other.

In a preprint published last month, a group of researchers published their model, which found that the decision to delay the first shot until the baby is 2 months old could lead to 90 additional acute infections, 75 chronic infections, 29 related deaths and $16 million in spending for one birth cohort.

Another group that includes the Hepatitis B Foundation, Emory University and Gilead Sciences, which markets a hepatitis B drug called Vemlidy, produced its own model. That one found that delaying the first shot from birth to 2 months of age could lead to 1,400 new infections, 480 deaths and $222 million in healthcare costs "for each year the revised recommendation is in place."

"We've made so much progress over the decades of eliminating disease in young children," said Su Wang, medical director for the Chinese Medical Program at Cooperman Barnabas Medical Center in New Jersey.

Wang, who spoke Thursday at the ACIP meeting, found out she had hepatitis B at 17, likely contracted from a caregiver.

"It feels like we're saying that it is OK now with kids getting hepatitis B and having this chronic disease that can shorten their life," she added.

Separately, a politically appointed Food and Drug Administration official last week told staff that at least 10 children died as a result of myocarditis caused by the COVID mRNA vaccines, based on internal research. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, has openly criticized some U.S. vaccine policies. Neither he nor any other FDA officials have publicly commented on the internal memo.

On Wednesday, 12 former FDA officials, including several commissioners, took aim at the "sweeping new FDA assertions about vaccine safety" in a perspective published in the New England Journal of Medicine.

-Jaimy Lee

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December 06, 2025 10:49 ET (15:49 GMT)

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