Delayed Hepatitis B Vaccination at Birth Increases Infant Infection Risk, Studies Show

New U.S. policy limiting hepatitis B vaccination at birth to only at-risk infants—adopted by the CDC in December after Health Secretary Robert F. Kennedy Jr. stacked the Advisory Committee on Immunization Practices with vaccine skeptics—is projected to cause 90-628 additional annual infections, 76 chronic infections, 29 deaths, and over $16 million in healthcare costs per birth cohort, according to studies from major universities. The policy reverses a 1991 universal birth dose recommendation that dramatically reduced infant hepatitis B infections, with babies infected having a 90% chance of chronic infection and 25% risk of premature death from liver disease. Many states have refused to adopt the new recommendation, major medical associations have stopped synchronizing with CDC guidance, and a federal judge preliminarily ruled the policy changes likely illegal in March.

Projected Health and Economic Impacts of the Policy Change

• ▪Babies who are infected with hepatitis B have a 90% chance of developing chronic hepatitis B infection
• ▪A study from Boston University, the University of Florida, and Johns Hopkins University estimated that additional hepatitis B infections annually could range from 69 if 80% of the babies recommended to have a birth dose actually got one to 628 if only 10% of those infants were vaccinated
• ▪A study from Oregon Health and Science University, the Los Angeles County Department of Public Health, Emory University, and Cornell University estimated that delaying the first dose of hepatitis B vaccine to two months of age for babies born to mothers who tested negative for the virus could result in more than $16 million dollars in additional health care costs for each year's birth cohort

The Controversial ACIP Recommendation and Its Legal Challenges

• ▪The Advisory Committee on Immunization Practices voted in early December to replace a decades-old recommendation that all babies be vaccinated at birth against hepatitis B with one that suggests only babies born to mothers who have either tested positive for the virus or who haven't been screened should be offered the vaccine at birth
• ▪The Centers for Disease Control and Prevention adopted the Advisory Committee on Immunization Practices hepatitis B vaccination recommendation shortly after the committee approved it in early December
• ▪Health secretary Robert F. Kennedy Jr. stacked the Advisory Committee on Immunization Practices with vaccine skeptics
• ▪In mid-March, federal court judge Brian E. Murphy issued a preliminary ruling that the restructuring of the Advisory Committee on Immunization Practices and subsequent changes to vaccination policy were likely illegal
• ▪The Advisory Committee on Immunization Practices recommendation suggests that parents of babies born to a mother who tested negative during pregnancy could decide whether to vaccinate later, suggesting the first dose not be given before 2 months of age in these cases
• ▪Many states have declared they will not adopt the Advisory Committee on Immunization Practices hepatitis B vaccination recommendation
• ▪The hepatitis B birth dose has been given to tens of millions of children in the United States and hundreds of millions around the world
• ▪Currently about 86% of pregnant people are tested for hepatitis B

Implementation Concerns and Historical Precedent from 1999

• ▪In 1999 the American Academy of Pediatrics recommended pausing the hepatitis B birth dose in babies born to mothers who tested negative for hepatitis B because of concerns at the time about the vaccine preservative thimerosal
• ▪The percentage of babies who receive hepatitis B birth doses dropped to 73.2% in August 2024 from 83.5% in February 2023
• ▪The universal hepatitis B birth dose recommendation went into effect in 1991, leading to a dramatic reduction in the number of babies who contracted hepatitis B during infancy
• ▪During the period when the universal hepatitis B birth dose recommendation was paused in 1999, the percentage of vaccinated babies born to mothers who had not been screened for hepatitis B fell from 53% to 7%

Perspective of Public health researchers and medical associations

• ▪The American Academy of Pediatrics brought a legal case challenging the restructuring of the Advisory Committee on Immunization Practices and subsequent hepatitis B vaccination policy changes

Perspective of Health Secretary Robert F. Kennedy Jr. and vaccine skeptics

• ▪The Advisory Committee on Immunization Practices voted to replace the universal hepatitis B birth dose recommendation with one targeting only at-risk infants in early December