The U.S. Advisory Committee on Immunization Practices (ACIP) has voted to modify its longstanding recommendation for universal hepatitis B virus (HBV) vaccination immediately after birth.
New Vaccination Guideline
On Friday, the ACIP voted 8-3 in favor of an "individual-based decision-making" approach for newborns whose mothers have tested negative for HBV. This decision alters the previous U.S. recommendation, which, since 1991, has advocated for universal hepatitis B vaccination for all newborns. Data indicates that the prior policy is associated with the prevention of an estimated 90,000 deaths.
The new guidance also suggests that if a birth dose of the vaccine is not administered, the initial dose should be given "no earlier than two months of age." The panel's recommendation for a birth dose remains in place for infants born to mothers who have tested positive for HBV. The modification is not expected to impact insurance coverage for the vaccine.
Context and Political Involvement
In June, Health Secretary Robert F. Kennedy Jr. replaced the members of the ACIP with individuals who have expressed critical views on vaccines. Following the ACIP's vote, President Donald Trump directed his top health officials to review all U.S. childhood vaccination recommendations. He requested a comparison of U.S. practices with those of "peer, developed countries" and indicated that the U.S. schedule should be altered if other countries' practices are deemed superior. President Trump publicly praised the advisory committee's decision.
Hepatitis B: Transmission and Risks
Hepatitis B is a liver infection that can be transmitted through direct contact with bodily fluids. The virus can lead to severe liver conditions, including cancer, liver failure, and cirrhosis. Pregnant individuals infected with HBV can transmit the virus to their newborns during delivery, potentially resulting in chronic infections and liver damage. Individuals infected with HBV may not exhibit symptoms, making them unaware carriers capable of transmitting the virus. Research indicates that HBV can spread through indirect contact, such as shared toothbrushes and razors, in addition to sexual contact and the sharing of needles.
Arguments Presented During the Meeting
The ACIP's decision followed a two-day meeting, during which the vote on hepatitis B vaccinations had been postponed twice prior. Arguments for the change included claims that the risk of contracting the virus is low for all newborns and that vaccination schedules should be tailored to individual patients. Some committee members, including Retsef Levi, argued that the previous U.S. hepatitis B vaccine policy was "misaligned" with practices in other countries. Critics of the birth dose specifically advocated for vaccination only in cases where the mother tests positive for the virus.
Conversely, some public health experts and committee members expressed concerns about the potential for an increase in hepatitis B infections. Dr. Cody Meissner, who voted against the change, stated that the hepatitis B vaccine is "safe and very effective" and predicted that the proposed changes would lead to "more children and adolescents and adults infected with hepatitis B." Concerns were also raised that not all pregnant individuals have consistent access to HBV testing or may receive false-negative results, potentially leaving some infants at risk if universal birth dose recommendations are rescinded.
International Vaccination Schedules
International recommendations for HBV vaccination vary:
- The World Health Organization (WHO) recommends vaccinating children against HBV at birth, one month, and six months of age.
- In the United Kingdom, vaccines are recommended at eight weeks, 12 weeks, and 16 weeks of age, unless the mother has tested positive for the virus.
Reactions to the ACIP Vote
Republican Senator Bill Cassidy, a physician, issued a statement criticizing the change, describing it as "a mistake" given his experience treating hepatitis B patients. He affirmed the safety and effectiveness of the vaccine and clarified that the birth dose is a recommendation, not a mandate. In Maryland, the state's health department issued an advisory, citing the American Academy of Pediatrics' recommendation, urging healthcare providers and hospitals to continue offering birth dose HBV vaccines and stating its commitment to ensuring vaccine access for all infants and children in the state.