This summer, the Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) announced its intention to review and revisit longstanding recommendations to administer an initial dose of vaccine against the hepatitis B virus (HBV) to all newborns. During their September meeting, ACIP members debated postponing the initial dose for infants born to mothers with documentation of negative HBV screening results to begin instead at one month of age. The Committee ultimately deferred a formal vote on changing the universal birth dose recommendation to a future meeting. Subsequent comments from the President suggested a desire to recommend delaying HBV childhood vaccination until age 12.
The National Viral Hepatitis Roundtable (NVHR) regards HBV immunization as a vital pillar towards eliminating viral hepatitis as a public health threat. While periodic review of immunization recommendations is appropriate, we are concerned that a perceived rush to a predetermined outcome of ending the universal birth dose recommendation runs counter to the Administration’s goal of transparency in scientific policymaking and commitment to “gold standard science.” We offer the following considerations and recommendations in the spirit of contributing to an important public health dialogue with widespread implications for building confidence in our nation’s immunization system, protecting children’s health, and evidence-based public health.
Considerations for reviewing universal HBV birth dose recommendations:
NVHR recommends that a clear, thorough, and transparent framework for evaluating evidence and formulating recommendations be established prior to reviewing and voting on childhood immunization policy. Specifically, a comprehensive review must include:
Understanding the risks and tradeoffs of postponing HBV immunization: How many preventable perinatal and pediatric infections would not be averted under a delayed HBV immunization schedule? What would be the projected long-term liver disease and liver cancer outcomes for these preventable infections?
Implementation considerations: What implementation changes and challenges would be anticipated from shifting the childhood HBV immunization schedule away from universal birth dose? How would this change affect the components of the childhood immunization that include subsequent doses of the HBV vaccine series in combination vaccines? What would be the short-term implications for providers, payers, parents, and manufacturers?
Structuring recommendations to allow preservation of birth dose as an option: In lieu of a wholesale change to the universal birth dose recommendation, adding language to provide guidance to parents and providers choosing through shared clinical decision-making to delay first dose of HBV vaccine on optimal timing for initiating the HBV immunization series would affirm individual decision-making while minimizing the risks of disruption and the severe consequences of preventable infections in the pediatric population.
Paths forward towards HBV elimination:
The dramatic success of our efforts to prevent perinatal HBV transmission cannot be considered complete, and further progress depends not only on maintaining and strengthening confidence in childhood immunization but also on addressing other drivers of the HBV epidemic. While outside of the immediate purview of ACIP, NVHR urges attention and action on the following priorities:
Improving ascertainment of maternal HBV status: While substantial efforts have been made to implement recommended HBV screening during pregnancy, roughly one in seven births are to mothers missing documentation of HBV serology. Similar gaps are seen in receipt of guidelines recommending syphilis screening during pregnancy, suggesting deeper challenges in ensuring access to high-quality prenatal care.
Increasing adult diagnosis and immunization rates: one-time HBV screening is recommended for all adults regardless of risk factors, and HBV immunization is recommended for adults aged 19-59 regardless of risk factors and without evidence of prior immunization. In practice, screening and immunization coverage among adults remain low, and over half of people with chronic HBV remain undiagnosed.
Support HBV drug development: Effective treatments for chronic HBV can suppress viral replication and reduce the risk of long-term disease progression and liver cancer, but do not provide a cure. Increased support for research and drug development will be necessary for further progress towards a functional cure.
NVHR reiterates our support for this statement of concern on ACIP’s review of hepatitis B birth dose immunization. For further information on HBV birth dose, see the following resources:
Hepatitis B Foundation birth dose media toolkit
Children’s Hospital of Philadelphia Vaccine Education Center
Vaccinate Your Family