The Centers for Disease Control and Prevention’s vaccine advisory committee meets Thursday for the first of two days of discussions on childhood vaccine schedules and recommendations. The main focus is the hepatitis B vaccine: panel members will vote on whether to keep recommending the first dose at birth or to delay that initial shot.
Hepatitis B has been universally recommended for newborns in the U.S. since 1991. Research shows infections among infants and children have fallen by about 99% since that recommendation. Hepatitis B is an incurable viral infection that can lead to chronic liver disease, cancer and premature death.
The birth dose has come under attack from vaccine skeptics, including Health and Human Services Secretary Robert F. Kennedy Jr., who has falsely asserted on a podcast that the newborn 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 newborns receive the vaccine
Hepatitis B is spread primarily through blood and other bodily fluids and can survive on surfaces for up to a week. It can be transmitted from an infected mother to her baby at birth and can also be passed to infants by caregivers. Because infected adults often have few or no symptoms, they can unknowingly transmit the virus; the CDC estimates roughly half of the about 2.4 million people in the U.S. with hepatitis B are unaware they are infected.
When administered within 24 hours of birth, the vaccine — the birth dose — is up to 90% effective at preventing mother-to-child transmission. With the full three-dose series, about 98% of children develop immunity. Babies infected at birth or within their first year face about a 90% chance of developing chronic hepatitis B, and roughly 25% of those with chronic infection die prematurely from liver-related disease.
Earlier public-health strategies relied on prenatal screening to identify infected mothers and vaccinate only infants born to positive mothers, but that approach missed many infections. The CDC still recommends testing pregnant women, yet experts say about 16% of expecting mothers can fall through the cracks. Public-health officials call the birth dose a critical safety net against gaps in prenatal screening, missed diagnoses, communication errors and inconsistent follow-up.
Parents are not legally required to vaccinate newborns for hepatitis B, although many schools and day cares require the series for enrollment. The birth dose and subsequent shots have kept transmission rates low: CDC data from 2021 show about 17,827 infants were born to mothers who tested positive for hepatitis B that year, and there were only 17 reported cases of newborn transmission — a reduction public-health officials attribute largely to the birth dose.
What experts say
Medical organizations such as the American Academy of Pediatrics (AAP) and the American Medical Association say extensive research supports the vaccine’s safety. Studies have not linked the hepatitis B vaccine to infant death, fever or sepsis, multiple sclerosis or autoimmune disorders. Severe reactions are rare; the most commonly reported adverse effects are brief 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 giving the birth dose to buckling a seat belt as a preventive measure.
Sen. Bill Cassidy, a physician who formerly chaired the Senate HELP Committee and whose clinical work 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 runs two days. In addition to voting on whether to keep the birth-dose recommendation, the committee will discuss childhood vaccine schedules; no vote on the schedule is planned. The agenda features presentations, deliberations 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 proposal.
Possible consequences of changing the recommendation
ACIP’s votes are forwarded to the CDC director for approval and can shape federal policy. States typically base vaccine mandates and school-entry requirements on CDC guidance but can set independent rules. ACIP recommendations also influence insurance coverage: most private insurers are required to cover vaccines the committee endorses, so altering the guidance could affect payer coverage for hepatitis B shots.
Many doctors warn that delaying the first dose or weakening the recommendation could raise infection rates, leading to more chronic disease and premature deaths. Three leading infectious-disease specialists wrote in JAMA that postponing the vaccine beyond the newborn period “introduces lifelong risks with no measurable health benefit.” They cited randomized trials, ongoing safety monitoring and large cohort studies that consistently confirm the vaccine’s safety and show no evidence that waiting until a child is a month old provides a safety advantage.
“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 a delay would be too late to prevent infection and would likely lead to more cases, greater circulation of the virus and higher costs to patients and the health system.
“There’s no reason to delay or space out vaccines,” O’Leary added. “Doing so just puts children at risk.”
Edited by Paula Cohen