The US Advisory Committee on Immunization Practices (ACIP) has voted to recommend delaying the hepatitis B virus (HBV) vaccination administered to newborns. In a vote of 8 to 3, the committee now recommends that the hepatitis B vaccination is administered to children of HBV-negative mothers beginning at two months of age, rather than the previous recommendation for all newborns to receive the first dose within 24 hours of birth. The Centers for Disease Control and Prevention (CDC) has not yet confirmed that the recommendation will be officially adopted, pending a decision by the CDC director. However, if approved, this will likely lead to an increase in paediatric cases of hepatitis B.
HBV is transmitted through infected blood and body fluids and can remain on contaminated surfaces for at least seven days. Acute hepatitis B is a short-term illness that occurs within the first six months following HBV exposure. However, if the body fails to clear the virus after six months, chronic hepatitis B (CHB) virus infection occurs. CHB is a lifelong disease for most patients, who are then at a high risk of developing life-threatening complications including liver cirrhosis and hepatocellular carcinoma.
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HBV is a public health threat, in part, due to the underdiagnosis of patients. According to GlobalData, in 2024 only 59% of people with CHB in the US were diagnosed and therefore aware of their infection status. Low diagnosis rates are primarily attributed to the virus’ asymptomatic nature. The majority of people newly infected with HBV show no symptoms, but for those who do, symptoms can include fatigue, poor appetite, stomach pain, nausea and jaundice.
Although the CDC recommends that all pregnant women receive testing for HBV, some do not and therefore remain unaware about their HBV status. This leaves a percentage of newborns at high risk for disease. The risk of CHB infection in HBV-infected infants is approximately 90%, which makes this particular population of patients crucial for preventing long-term infection and complications.
Key opinion leaders interviewed by GlobalData agree that some of the biggest unmet needs within CHB include the need for increased screening measures and awareness of preventive measures, including vaccinations. The World Health Organization (WHO) is working to address these unmet needs, through the Global Health Sector Strategy on eliminating viral hepatitis, as diagnosis rates are even lower among the global population. According to the WHO, more than 80% of individuals living with hepatitis B globally are unaware of their diagnosis.
The recommendation to delay the HBV vaccination in newborns directly contradicts the WHO’s guidance in eliminating viral hepatitis, which has called upon nations to implement universal HBV birth dose vaccination policies. This policy acts as a safety net to prevent HBV and CHB in all newborns, regardless of the HBV status of the mother. Unfortunately, this new recommendation in the US will likely lead to an increase in paediatric cases of hepatitis B, and further fuel the public health issue surrounding the underdiagnosis of HBV.
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By GlobalData