An advisory committee to the Centers for Disease Control and Prevention (CDC) is scheduled to vote on December 4 regarding potential changes to the long-standing recommendation for universal hepatitis B vaccination of all newborns in the United States. This review, which could impact vaccine access and state policies, has prompted discussion among medical professionals regarding potential public health implications. The hepatitis B virus, transmitted through blood and bodily fluids, can lead to severe health outcomes including liver cancer and cirrhosis, particularly when contracted in infancy.
Background on Hepatitis B and Vaccination
The hepatitis B virus targets the liver and is transmitted through blood, saliva, semen, and other bodily fluids. It can remain viable on surfaces for up to a week. Before the vaccine became available in the 1980s, the virus resulted in severe illness and fatalities, including liver cancer. Many individuals historically contracted hepatitis B at birth or in early childhood. The disease currently lacks a cure, and chronic infection is associated with outcomes such as liver cancer, cirrhosis, and death. Infants infected with the virus face significantly higher risks for these severe outcomes, with approximately 25% of children who develop chronic hepatitis B succumbing to the infection.
A birth dose of the hepatitis B vaccine has been recommended for newborns in the U.S. since 1991. When administered within the first 24 hours of life, it is up to 90% effective in preventing maternal-to-infant transmission. When all three doses are received, 98% of recipients develop immunity for at least 30 years. Since the implementation of routine newborn vaccination in the U.S., case rates among individuals aged 19 and younger have decreased by 99%. In western Alaskan communities, targeted testing and vaccination efforts have resulted in no reported pediatric liver cancer cases since 1995 and no new infections in individuals under 30.
Advisory Committee Review and Perspectives
The Advisory Committee on Immunization Practices (ACIP), a panel appointed by Health and Human Services Secretary Robert F. Kennedy Jr., is scheduled to discuss and vote on the hepatitis B birth dose recommendation on December 4. ACIP recommendations influence private insurer vaccine coverage and state vaccination policies. While ACIP and the CDC do not mandate immunizations, changes to recommendations can affect vaccine timing and insurance coverage options for families.
Robert F. Kennedy Jr., the Health Secretary, has expressed doubts regarding the safety and effectiveness of the newborn hepatitis B vaccine dose. He has linked an ingredient in the shot to autism without providing supporting evidence and has characterized the U.S. as a "high outlier" in the number of recommended childhood immunizations, providing a rationale for reconsideration of the newborn hepatitis B vaccine. While the CDC recently adjusted its broader recommended childhood vaccine schedule, the specific universal hepatitis B birth dose recommendation remains under review by the ACIP panel. A Department of Health and Human Services memo from November indicated that 20 peer nations, excluding Denmark and Finland, recommend the hepatitis B vaccine for all children, either at birth or later. Decades of research indicate the virus can be transmitted through indirect contact, such as shared personal items, and is considered more infectious than HIV. The hepatitis B birth dose is administered as a stand-alone vaccine.
Medical professionals have raised concerns about potential severe health consequences if the universal recommendation is withdrawn. Dr. Sean O'Leary, chair of the Committee on Infectious Diseases for the American Academy of Pediatrics, stated concerns that such discussions could foster distrust in the vaccine. Mischaracterizations of the virus's spread have occurred, with some individuals downplaying the risk of transmission through indirect contact. Studies from the 1970s indicated that a significant percentage of children infected via indirect contact developed chronic hepatitis B without initial symptoms. Public health experts anticipate a decrease in childhood vaccination rates following any changes to CDC recommendations.
An analysis released prior to peer review suggested that delaying the birth dose of the vaccine by two months could lead to at least 1,400 additional preventable cases of hepatitis B annually. Delaying the vaccine until age 12, as suggested by President Trump this year, could result in at least 2,700 preventable infections each year.
FDA officials Marty Makary and Vinay Prasad suggested in late November that changes to vaccine approval processes might occur. Dr. Prasad questioned the routine practice of "giving multiple vaccines at the same time."
A spokesperson for Health and Human Services, Emily G. Hilliard, stated that ACIP would review evidence at its meeting and issue recommendations based on "gold standard, evidence-based science and common sense."
Transmission, Prevalence, and Prevention
Before the implementation of universal newborn vaccination in the U.S. in 1991, approximately 18,000 children annually were infected before reaching age 10, with around half of these infections occurring through mother-to-child transmission. The virus can survive on surfaces for up to seven days. Unvaccinated individuals, including children, can contract the virus from microscopic amounts of blood on surfaces, even if the infected person is asymptomatic. Documented cases of infection in children have occurred in settings such as day care centers, sports teams, and through shared toothbrushes and razors. The Centers for Disease Control and Prevention estimates that about half of individuals infected with hepatitis B are unaware of their status but can still transmit the virus unknowingly.
The CDC estimates that up to 16% of pregnant individuals are not screened for hepatitis B, and experts note that routine pre- or post-delivery testing in hospitals can be challenging due to staffing and resource limitations. Dr. William Schaffner, a professor of preventative medicine, advises expectant parents to consult their doctors about the vaccine, emphasizing that even if a pregnant individual tests negative, administering the birth dose is important due to the possibility of false negatives and the virus's ease of spread via surface contact. Babies who complete the full vaccine series starting at birth experience an 84% reduction in their chance of developing liver cancer. Delaying vaccination can allow the infection to become established in an infant's liver.
Vaccine Safety and Economic Impact
The three-dose hepatitis B vaccine has a documented safety record. Numerous studies have found no association between the vaccine and increased risks of infant death, fever, sepsis, multiple sclerosis, or autoimmune conditions. Severe reactions are rare, with commonly reported adverse events from the newborn birth dose including temporary fussiness and crying.
The CDC estimates that 2.4 million people in the U.S. have hepatitis B, with approximately half unaware of their infection status. The disease can manifest as an acute or chronic infection, often with few or no symptoms. Untreated chronic infection can progress to conditions such as cirrhosis, liver failure, and liver cancer. There is no cure; treatment options involve antiviral or immunomodulator medications, which are weighed against potential side effects. Public health experts attribute over 1,800 annual deaths to hepatitis B in the U.S.
Reduced vaccination rates could lead to higher circulation of hepatitis B in communities, increasing the risk for unvaccinated individuals. The economic burden of hepatitis B treatment is substantial, with less severe cases costing an estimated $25,000 to $94,000 annually. Liver transplant patients face annual medical expenses exceeding $320,000.
Global Context: Hepatitis B in Ghana
Ghana, a West African nation, faces a significant hepatitis B challenge, with nearly one in ten Ghanaians having chronic hepatitis B. Approximately 10,000 new infections are reported annually in the country of 35 million, in contrast to the CDC's estimate of 20,700 new infections annually in the U.S. Deaths from hepatitis B complications in Ghana reached 14,000 in 2022. Charles Adjei, executive director of the Hepatitis Alliance of Ghana, noted the substantial cost of treatment for patients, families, and the health system, with patients typically paying out-of-pocket.
In Ghana, mother-to-child transmission is a major concern, with the risk ranging from 10% to 90% depending on the mother's infection severity. Approximately 95% of infected infants acquire lifelong infections. A birth-dose vaccine administered within 24 hours of birth, followed by two subsequent doses, is 75% to 95% effective in preventing transmission. Despite a 2009 World Health Organization recommendation for all countries to administer the vaccine at birth, this intervention is not widely available in Ghana.
Ghana has maintained a national hepatitis B vaccination effort since 2002, achieving up to 95% coverage, primarily with the pentavalent vaccine, first given around one month of age. This timing is often too late to prevent infections that can occur during birth or in utero; studies indicate a seven-day vaccination delay can increase infection risk ninefold. Many mothers in Ghana are unaware of their infection status due to limited testing availability, and some pregnant women are required to pay for testing that should be free.
Ghana's health budget has been strained, making it insufficient to cover a newborn hepatitis B vaccination program. Gavi, an organization funding immunizations for lower-income countries, co-finances Ghana's pentavalent vaccine. Following public pressure and advocacy efforts, Gavi's board agreed in 2018 to support hepatitis B birth doses starting in 2021, though the COVID-19 pandemic caused delays. In 2024, Gavi announced it would help cover the cost of newborn vaccines, providing a framework for Ghana to co-purchase mass quantities. The Ghanaian government has aimed to launch an immunization campaign, with an initial target of September last year. Charles Adjei anticipates the campaign will launch in 2026, though uncertainty persists.