The Centers for Disease Control and Prevention’s vaccine advisory panel meets Thursday for the first of two days of discussions about childhood vaccine schedules and recommendations. The panel will focus on the hepatitis B vaccine and vote on whether to continue recommending it for all children at birth or to delay the first dose.
The hepatitis B vaccine has been universally recommended for newborns in the U.S. since 1991. Research shows hepatitis B infections among infants and children have dropped 99% since the recommendation. Hepatitis B is an incurable infection that can lead to liver disease, cancer and early death.
The shot has become a target of vaccine skeptics, including Health and Human Services Secretary Robert F. Kennedy Jr., who falsely claimed on a podcast that the birth dose is a “likely culprit” in autism. Kennedy has appointed all members of the Advisory Committee on Immunization Practices (ACIP) during his tenure as HHS secretary.
Why is the hepatitis B vaccine given to newborns?
Hepatitis B is primarily transmitted through blood and bodily fluids and can survive on surfaces for up to a week. It can be passed from mother to child at birth and transmitted to infants by caregivers. Infected adults often have few or no symptoms and can spread the virus unknowingly; the CDC estimates about half of the roughly 2.4 million people in the U.S. with hepatitis B do not know they are infected.
When given within 24 hours of birth — the birth dose — the vaccine is up to 90% effective at preventing mother-to-child transmission. If babies receive the full three-dose series, about 98% develop immunity. Newborns infected at birth or infants infected within their first year have a roughly 90% chance of developing chronic hepatitis B, which can lead to cirrhosis, liver failure and liver cancer; about 25% of those with chronic infection die prematurely.
Earlier approaches targeted prenatal screening to higher-risk women and recommended the vaccine only for infants born to mothers who tested positive, but that missed many infections. The CDC still recommends pregnant women be tested, but about 16% of expecting mothers fall through the cracks. Public health experts say the birth dose serves as a critical safety net to protect against gaps in prenatal screening, missed diagnoses, communication errors and inconsistent follow-up.
Parents are not legally required to give the hepatitis B vaccine, though many schools and day care facilities require it. The birth dose and series have kept rates low: in 2021, CDC data showed about 17,827 children were born to mothers who tested positive for hepatitis B, and there were only 17 reported cases of newborn transmission that year, a reduction credited to the birth dose.
What do experts say?
Medical organizations, including the American Academy of Pediatrics (AAP) and the American Medical Association, say extensive research shows the hepatitis B vaccine is safe. Studies have not linked the vaccine to infant death, fever or sepsis, multiple sclerosis or autoimmune conditions. Severe reactions are rare; the main adverse events reported are transient crying and fussiness.
“The hepatitis B vaccine has one of the most well-established safety records of any vaccine and … we’ve been using it for a long time,” said Dr. Sean O’Leary, chair of the AAP Committee on Infectious Diseases. “It’s one of our best tools to protect babies from chronic illness and liver cancer. This is a situation where one missed case is too many.” He compared taking the birth dose to buckling a seat belt as a preventive measure.
Sen. Bill Cassidy, a physician who chaired the Senate HELP Committee and whose practice focused on hepatitis B, said the at-birth dose has “decreased incidence of chronic hepatitis B by 20,000 people over the last two decades” and expressed concern about changing the recommendation.
What to expect at the ACIP meeting
The ACIP meeting spans two days. In addition to voting on the hepatitis B birth dose recommendation, the panel will discuss childhood vaccine schedules; there is no vote planned on the schedule topic. A vote on the hepatitis B vaccine is scheduled for Thursday. The agenda includes presentations, discussions and time for public comment. The panel previously debated moving the birth dose to one month of age at its September meeting but tabled the topic.
What could happen if recommendations change?
ACIP’s recommendations go to the CDC director for approval and adoption as policy. States generally base their policies on CDC guidance but can set their own rules. The panel’s recommendations also influence insurance coverage; most private insurers are required to cover vaccines ACIP recommends, so a change could affect coverage for hepatitis B vaccines.
Doctors warn that delaying the first dose or weakening recommendations could increase infections, leading to more chronic disease and premature deaths. Three leading infectious-disease specialists wrote in JAMA that delaying beyond the newborn period introduces lifelong risks with no measurable health benefit. They noted randomized trials, safety monitoring and large cohort studies consistently confirm the vaccine’s safety and found no evidence of a safety benefit from waiting until a child is a month old.
“If you wait a month and if the mom happens to be positive, or the baby picks it up from a caregiver, by that time the infection is established in that baby’s liver,” said Dr. William Schaffner, professor of preventive medicine at Vanderbilt and a former ACIP voting member. He warned that waiting would be too late to prevent infection. More cases would mean the virus circulating at higher rates and higher costs for patients and the health system.
“There’s no reason to delay or space out vaccines,” O’Leary said. “Doing so just puts children at risk.”
Edited by Paula Cohen