New US Hepatitis B Vaccine Policy May Increase Infant Infections and Healthcare Costs

A shift in U.S. Hepatitis B vaccination policy for newborns is projected to lead to a rise in infant infections, chronic childhood hepatitis B cases, and millions of dollars in additional healthcare costs, according to two studies published Monday in JAMA Pediatrics.

The studies examine the consequences of a December 2025 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). The committee voted 8-3 to narrow the longstanding universal birth-dose policy, instead advising that hepatitis B vaccination at birth be reserved for infants born to women who test positive for the virus or whose hepatitis B status is unknown. For infants born to mothers who test negative, ACIP recommended shared clinical decision-making between parents and healthcare providers, with the option to delay the first dose until at least two months of age.

Projected Increase in Infections and Costs

One of the studies, conducted by researchers at Boston University, the University of Florida, and Johns Hopkins University, modeled the potential impact of the policy change. The analysis concluded that avoiding an increase in neonatal infections under the new targeted recommendation would require “historically unattained levels of maternal hepatitis B screening or birth-dose coverage among infants of unscreened mothers.”

The researchers projected that the policy shift could result in more infants becoming infected with hepatitis B in the first year of life, leading to a higher number of children developing chronic hepatitis B infection. Chronic hepatitis B, which can cause liver damage, cirrhosis, and liver cancer, would also generate additional healthcare costs, though the studies did not specify an exact dollar amount in the available summary.

Decades-Long Policy Reversed

The ACIP recommendation marks a significant departure from a policy in place for more than 30 years. Since the early 1990s, the CDC has universally recommended that all newborns receive their first dose of the hepatitis B vaccine within 24 hours of birth, regardless of maternal hepatitis B status. This approach has been credited with dramatically reducing hepatitis B infections among U.S. Children, particularly those born to mothers with undiagnosed infections.

During the December 2025 ACIP meeting, the committee acknowledged that the universal birth-dose policy had been effective but cited the need for individualized decision-making for infants born to mothers who test negative for hepatitis B. The recommendation allows parents and healthcare providers to weigh factors such as household exposure risks—including contact with individuals who have emigrated from regions where hepatitis B is common—when deciding whether to administer the vaccine at birth or delay it.

The ACIP also recommended that parents consult with healthcare providers to determine whether to test antibody levels in children who receive subsequent doses of the hepatitis B vaccine, using serology results to assess the adequacy of protection.

Medical Community Pushes Back

The policy change faced strong opposition from medical organizations during the ACIP meeting. Representatives from the Pediatric Infectious Diseases Society questioned the rationale behind altering a policy that had successfully reduced hepatitis B cases in children. “Our question is why? Why is there pressure today to change something that has been working, due to safety concerns that may be more theoretical than real?” said Dr. Grant Paulsen, a liaison to ACIP from the society, during the December 2025 meeting.

The universal birth-dose policy has been particularly effective in preventing perinatal transmission—when the virus is passed from mother to baby during childbirth. Even when maternal hepatitis B status is unknown at the time of delivery, the birth dose provides critical early protection. Under the new recommendation, infants born to unscreened mothers may not receive the vaccine until weeks or months later, increasing their vulnerability to infection.

Coverage and Access Remain Unchanged

Despite the shift in recommendations, the ACIP emphasized that the policy maintains consistency in vaccine coverage across payment mechanisms. This includes entitlement programs such as the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans offered through the federal Health Insurance Marketplace. The change does not affect access to the vaccine but rather alters the timing and circumstances under which it is recommended.

Uncertainty Over Implementation

The studies published Monday highlight potential challenges in implementing the new recommendation. Achieving high rates of maternal hepatitis B screening before delivery and ensuring timely vaccination for infants of unscreened mothers will be critical to mitigating the projected rise in infections. However, the researchers noted that such levels of screening and coverage have not been historically achieved, raising concerns about the real-world impact of the policy shift.

Public health experts continue to monitor the situation, with some advocating for further research to assess the long-term consequences of delaying the birth dose for certain infants. The CDC has not yet indicated whether additional guidance or adjustments to the recommendation will be considered in response to the studies’ findings.