CDC Committee Changes Newborn Hepatitis B Vaccine Guidance

Federal health officials shook up longstanding childhood immunization guidance on Dec. 5, leaving decisions about when and whether to vaccinate infants for hepatitis B to parents and health-care providers. 

The U.S. Centers for Disease Control and Prevention’s (CDC) expert panel determined that the vaccine, a three-shot series that previously included a dose at birth, is effectively discretionary. 

The panel previously recommended a newborn dose of the vaccine—regardless of the birth parent’s hepatitis B status—followed by a second dose between 1 and 2 months of age. A final dose was recommended between 6 and 18 months of age. 

The new guidance also says that infants who are not vaccinated at birth but whose parents wish to vaccinate them eventually should not receive their first inoculation against hepatitis B until they are at least 2 months old. The CDC continues to recommend that children born to a hepatitis B-positive parent—or to a parent whose hepatitis B status is unknown—be vaccinated at birth.

The panel also voted to alter existing guidelines in a way that calls into question whether all children need the full three-dose series of the hepatitis B vaccines. The new guidance recommends that parents consult with providers to decide whether to test for hepatitis B immunity levels before proceeding with a second or third dose of the vaccine. Several participants at the meeting, including a CDC expert, expressed concern that scientific data does not support this approach. 

The recommendations will become final once adopted by the CDC director. 

Why vaccinate newborns for hepatitis B?

The two-day meeting of the Advisory Committee on Immunization Practices (ACIP) held on Dec. 4 and 5, 2025—which included heated arguments among panelists and outside experts over some members’ unsupported beliefs about vaccination—multiple panelists suggested that the hepatitis B vaccine poses significant health and safety risks to newborns. But the available science shows the opposite is true. 

Inoculation right after birth “maximizes the effectiveness of the vaccine in preventing newborn infection,” according to the American Academy of Pediatrics (AAP).

Hepatitis B is transmitted through blood and sexual fluids, and can spread from a pregnant person to their infant both in utero and during childbirth. If untreated, the inflammation caused by chronic hepatitis B infection can lead to scarring of the liver that causes the organ to fail.

People infected at birth with chronic hepatitis B who never received treatment face up to a 25 percent lifetime risk of developing liver cancer, according to the Hepatitis B Foundation. Those infected with hepatitis B face up to a 4 percent annual risk of liver cancer, depending on whether they have cirrhosis.

Endangering public health gains of last 34 years

Before 1991, when the U.S. launched a vaccination program designed to stamp out hepatitis B infections acquired during pregnancy and childbirth, roughly 18,000 to 20,000 babies were diagnosed each year, said Dr. James Campbell, the vice chair of the American Academy of Pediatrics’ committee on infectious diseases. Today, only 20 to 30 are.

Most hepatitis B infections can be linked to a specific risk factor, like intravenous drug use, sex with an infected person, or being born to a hepatitis B-positive individual. But up to one-third can’t be, Campbell said.

“We don’t know where everybody gets it from,” Campbell added. “Giving all babies the vaccine protects them from both known and unknown risks for getting hepatitis B.”

The panel is also expected to debate the remainder of the childhood vaccine schedule on Dec. 5. ACIP already altered federal vaccine guidance for measles, mumps, rubella, varicella, and COVID-19, in September 2025. 

Editor’s note: This is an updated and condensed version of a story originally published on Sept. 19, 2025.

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