CDC Adopts Individual-Based Decision-Making for Hepatitis B Vaccine for Infants

The Centers for Disease Control and Prevention (CDC) has officially adopted individual-based decision-making for the hepatitis B vaccine for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. ¹

This comes after the CDC’s Advisory Committee on Immunization Practices (ACIP) 2-day meeting, (December 4-5), discussing the recommended universal birth dose of the hepatitis B vaccine.

"This recommendation reflects ACIP's rigorous review of the available evidence," Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O'Neill, said in a statement. ¹

It is important to note, the decision to immunize children against hepatitis B has always come with parental consent, and that no safety data was presented showing adverse effects in giving the birth dose during this month’s ACIP meeting.

This new recommendation is a major change in the face of the previous long-standing vaccine recommendation that all infants be administered the first dose of the hepatitis B virus (HBV) immunization within 12-24 hours of life. This previous guidance had been established practice for decades, and demonstrated great efficacy. In fact, the universal HBV vaccine birth dose recommendation has long been seen as a successful public health program.

Between 1991 and 2019, HBV infection among children and adolescents dropped 99%, preventing tens of thousands of cases of cirrhosis, liver cancer, and death.² 

With this recommendation change, negative medical results could be realized. A recent modeling analysis found that by delaying the birth dose to 2 months among infants whose mothers are not known to be living with hepatitis B, there could be at least 1400 preventable hepatitis B infections among children, 300 excess cases of liver cancer, 480 preventable deaths, and over $222 million in excess health care costs for each year the revised recommendation is in place. ³

Additionally, for each year a delayed birth dose policy is in place, the modeling projections show that delaying the birth dose to 2 months would result in at least 62 preventable deaths and 39 cases of liver cancer.³

CDC said that for infants born to mothers who test positive for hepatitis B or whose status is unknown, the currently recommended birth dose of hepatitis B vaccine and immunoglobulin continues with no change.

Also the federal agency said the adoption of individual-based decision-making for hepatitis B immunization maintains consistency of coverage through all payment mechanisms, including entitlement programs such as the Vaccines for Children Program, Children's Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.¹

Serology Testing

In the announcement yesterday, the federal agency said it was reviewing ACIP's secondary recommendation that parents should consult with a health care provider on serology testing to determine whether a subsequent hepatitis B vaccine dose is needed.¹

During these recent ACIP meetings, no formal guidance was provided or data to support this new testing. Additionally, it is not understood how this would be executed in clinical practice or if this would be a test medical insurance would cover.

References
1. CDC Adopts Individual-Based Decision-Making for Hepatitis B Immunization for Infants Born to Women Who Test Negative for Hepatitis B Virus. CDC press release. December 16, 2025. Accessed December 17, 2025.
https://www.cdc.gov/media/releases/2025/2025-hepatitis-b-immunization.html

2. APHA joins GW and dozens of public health and policy experts urging the CDC to maintain universal newborn hepatitis B vaccination. Press release. American Public Health Association. December 2, 2025. Accessed December 10, 2025. https://www.apha.org/news-and-media/news-releases/apha-news-releases/public-health-and-policy-experts-urge-the-cdc-to-maintain-universal-newborn-hepatitis-b-vaccination

3.New analysis shows delaying the hepatitis B birth dose may lead to thousands of preventable infections and hundreds of millions in avoidable healthcare costs. HepVu. December 1, 2025. Accessed December 2, 2025.
https://hepvu.org/news-updates/new-analysis-shows-delaying-the-hepatitis-b-birth-dose-may-lead-to-thousands-of-preventable-infections-and-hundreds-of-millions-in-avoidable-healthcare-costs/