Medical professionals have expressed concerns regarding potential changes to the recommended birth dose of the hepatitis B vaccine for newborns. These discussions follow a scheduled review by a Centers for Disease Control and Prevention (CDC) vaccine advisory panel.
Understanding Hepatitis B
The hepatitis B virus is transmitted through blood and bodily fluids, even in microscopic quantities, and 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, in some communities. Dr. Brian McMahon, a liver specialist in Anchorage, Alaska, recounted cases where the virus led to liver cancer in young patients. Many individuals historically contracted hepatitis B at birth or in early childhood.
Vaccination Effectiveness and Impact
A birth dose of the hepatitis B vaccine, recommended for newborns since 1991, demonstrates up to 90% effectiveness in preventing maternal-to-infant transmission if administered within the first 24 hours of life. When all three doses are received, 98% of recipients develop immunity for at least 30 years. In western Alaskan communities, targeted testing and extensive vaccination efforts have led to a significant decrease in cases, with no reported pediatric liver cancer cases since 1995 and no new infections in individuals under 30.
Scheduled Policy Review
An Advisory Committee on Immunization Practices (ACIP) 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. This review could impact children's access to the vaccine.
In June, Robert F. Kennedy Jr. stated on a podcast that the hepatitis B birth dose is a "likely culprit" for autism and that the hepatitis B virus is not "casually contagious." However, decades of research indicate the virus can be transmitted through indirect contact, such as shared personal items, and is considered more infectious than HIV. Unvaccinated individuals, including children, can contract the virus from microscopic amounts of blood on surfaces, even if the infected person is asymptomatic.
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 the range of options available to families regarding vaccine timing and insurance coverage.
FDA Considerations
In late November, FDA officials Marty Makary and Vinay Prasad suggested that changes to vaccine approval processes might occur. Dr. Prasad questioned the routine practice of "giving multiple vaccines at the same time." It is noted that the hepatitis B birth dose is given as a stand-alone vaccine, not a combination vaccine.
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."
Public Health Concerns and Vaccine Safety
Dr. Sean O'Leary, chair of the Committee on Infectious Diseases for the American Academy of Pediatrics, expressed concern that 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 cited by Dr. McMahon indicated that a significant percentage of children infected via indirect contact developed chronic hepatitis B without initial symptoms.
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.
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.
Disease Prevalence and Economic Impact
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 immunomodulatory medications, weighed against potential side effects.
Expert Recommendations
Dr. William Schaffner, a professor of preventative medicine, advises expectant parents to consult their doctors about the vaccine. He emphasizes 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.
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, and liver transplant patients facing annual medical expenses exceeding $320,000.
Commonly reported adverse events from the newborn birth dose include temporary fussiness and crying. The vaccine program has been adopted by other countries.