A modeling study published in Annals of Internal Medicine warns that replacing the U.S. universal birth-dose hepatitis B vaccination policy with shared clinical decision-making could increase chronic childhood infections by 83%. Conducted by researchers at Harvard Medical School and Massachusetts General Hospital, the study evaluated proposed CDC guidelines permitting parents to delay or decline doses for infants born to virus-negative mothers, projecting up to 1.8 million young adults could be left vulnerable to lifelong liver disease.
Study projections on delayed hepatitis B vaccination
- ▪Researchers at Massachusetts General Hospital and Harvard Medical School used a Markov state-transition model of 3.6 million U.S. infants to evaluate proposed changes to the hepatitis B childhood immunization schedule.
- ▪A modeling study published on October 19, 2026, in Annals of Internal Medicine projected that adopting a shared decision-making policy for hepatitis B vaccination would increase chronic infections by 83% in a single-year U.S. birth cohort.
- ▪The study by Dr. Amir Mohareb and colleagues projected that delaying the first hepatitis B vaccine dose to age 2 months would cause a 19% increase in chronic childhood infections.
Infection projections under reduced vaccination scenarios
- ▪The study estimated that if shared decision-making leads to a 26% vaccination rate, chronic hepatitis B cases would increase by 225%, resulting in 575 chronic infections.
- ▪If a shared decision-making model leads to lower vaccine uptake, the study calculated that up to 1,806,000 young adults could enter adulthood susceptible to hepatitis B by year 20, compared with 232,000 under a universal birth-dose policy.
- ▪In a scenario combining lower birth-dose coverage with higher overall population virus prevalence, shared decision-making could lead to 2,192 chronic childhood hepatitis B infections.
Proposed CDC hepatitis B policy changes
- ▪Health Secretary Robert F. Kennedy Jr. and his advisers argued that hepatitis B is spread primarily through sexual contact, making universal newborn protection unnecessary if the mother tests negative.
- ▪In December 2025, the CDC's Advisory Committee on Immunization Practices recommended ending universal birth doses for infants of hepatitis B-negative mothers, shifting to shared clinical decision-making or delaying the first dose until at least two months.
Hepatitis B transmission and health risks
- ▪Ninety percent of infants infected perinatally with hepatitis B develop chronic infection, and one in four people with untreated chronic infections develops cirrhosis or liver cancer.
- ▪Hepatitis B can be transmitted by individuals who do not know they carry the virus, as well as through shared household items used by an infected person.
Established hepatitis B vaccination guidelines
- ▪Universal hepatitis B vaccination at birth within 24 hours of delivery has been recommended routinely for all U.S. infants since 1991 to prevent chronic infection and liver disease.
- ▪For infants born to mothers known to be infected with hepatitis B, the established standard is to administer the first vaccine dose within 12 hours of life.
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