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What is the AAP recommendation around hepatitis B immunization?

The AAP’s recommendations regarding hepatitis B vaccination have not changed in response to the ACIP meeting votes. The AAP continues its current recommendation for the birth dose of hepatitis B vaccine for newborns within the first 24 hours of life.  Additionally, AAP continues to recommend subsequent hepatitis vaccine doses between 1-2 months and 6-18 months.  

 

Is there any benefit to serologic testing of newborns to see if fewer doses of Hepatitis B vaccine can be administered?

The AAP does not recommend serology testing for infants to guide further Hep B vaccination, as the significance of Hep B sAb level of >10 mIU/mL in early infancy is unknown.  There is also insufficient evidence regarding the significance of antibody levels obtained mid-series and the relationship with long-term immunity against hepatitis B, particularly in this age group. These laboratory results would not reliably represent immune status or a scientific basis for a decision to continue or forego subsequent vaccination. This laboratory test represents an unnecessary blood test and procedure for infants, a barrier for families, additional costs, a risk for immunity delay, and other potential harms to infants without conferring value for evidence-based decision making in a clinical setting. 

If the Acting CDC Director approves the ACIP recommendations to delay the hepatitis B vaccine birth dose, the shared clinical decision making recommendation provides a payment pathway for hepatitis B vaccine administration at birth. Additionally, the Vaccines for Children (VFC) program would continue to distribute hepatitis B vaccine for those that want it. Additional information about coding and payment for immunizations can be found on the AAP Vaccine Financing and Coding page. Please report any payer concerns or hassles to the Coding & Payment Hotline.

Will I face increased medical liability risk if I continue to administer hepatitis B vaccine birth dose?

If the Acting CDC Director approves the ACIP recommendations to delay the hepatitis B vaccine birth dose, the shared clinical decision making recommendation lessens the risk of liability greatly. 

Why is the universal birth dose of Hepatitis B so important?

  • Hepatitis B infection in infancy results in more serious disease burden: Around 90% of newborns infected with hepatitis b virus (HBV) develop chronic infection, compared to < 5% of adults infected later in life. But the birth dose eliminates this risk. People who were infected with hepatitis B at birth and are not treated have up to a 25% lifetime risk of developing liver cancer.
  • Chronic hepatitis B infection remains a major health issue, as roughly 660,000 Americans live with chronic hepatitis b infection and are often undiagnosed. This infection can easily be transmitted to others as the virus can live on surfaces outside of the body for more than 7 days.
  • Risk-based screening has proven unsuccessful in the US, as there are real-world gaps and limitations in screening. Current data show that 12-18% of pregnant people don’t receive hepatitis B surface antigen (HBsAg) testing and only 35% of those who test positive receive all recommended follow-up care. Additionally, about 35-65% of HBsAg-positive mothers had no identifiable risk factors that would flag them for targeted screening.
  • Universal screening works and the vaccine is safe. The universal hepatitis B vaccination program has resulted in a 99% decline in pediatric cases. The hepatitis B vaccinees have undergone randomized controlled trials including those with placebo-controlled designs, which have been summarized by CIDRAP’s Vaccine Integrity Project.  Additionally, the vaccine has a long-standing and proven safety record. 

Why does the US have a universal vaccination program for hepatitis B vaccine whereas other countries with a higher incidence of hepatitis B infection use a risk-based vaccination strategy successfully?

Risk-based strategies were tried throughout the 1980s in the US and failed to reduce incidence of infant infection. CDC data showed that 30–40% of hepatitis B patients had no identifiable risk factors, meaning targeted approaches would never reach them. Similarly, 35–65% of HBsAg-positive mothers had no identifiable risk factors and would never be flagged under targeted screening programs. 

Implementation of an effective risk-based vaccination strategy based on maternal screening results is dependent upon universal maternal screening of HBsAg. Current data show that 12–18% of pregnant women don't receive HBsAg testing. Of those who test positive, only 35% receive all recommended follow-up care. The fragmented US healthcare system is not set up to catch everyone through risk-based vaccination approaches. The US shifted to universal infant vaccination in 1991, which has resulted in a 99% decrease in infant hepatitis infections. 

Countries without a universal birth dose recommendation have smaller populations, high rates of universal prenatal screening, and high rates of adherence to recommended follow-up care. 

Are there guidelines for administration of hepatitis B vaccine at birth? What are the differences if the pregnant parent is HBsAg positive or their HBsAg status is unknown?

The following are key steps appropriately administering the birth dose of hepatitis B vaccine based on AAP policy:

  • Identify HBsAg-positive mothers before delivery and document maternal HBsAg status in infant records;
  • Resolve unknown HBsAg status of mothers as soon as possible around delivery, and document maternal status in infant records;
  • For all infants born to HBsAg-positive mothers, administer both hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth, regardless of any maternal antenatal treatment with antiviral medications;
  • For all infants with birth weight greater than or equal to 2000 g born to HBsAg-negative mothers, administer hepatitis B vaccine as a universal routine prophylaxis within 24 hours of birth;
  • For all infants with birth weight less than 2000 g born to HBsAg-negative mothers, administer hepatitis B vaccine as a universal routine prophylaxis at 1 month of age or at hospital discharge (whichever is first);
  • For all infants born to HBsAg-unknown mothers, administer hepatitis B vaccine within 12 hours of birth, and:
    • For infants with birth weight greater than or equal to 2000 g, administer HBIG by 7 days of age or by hospital discharge (whichever occurs first) if maternal HBsAg status is confirmed positive or remains unknown;
    • For infants with birth weight less than 2000 g, administer HBIG by 12 hours of birth unless maternal HBsAg status is confirmed negative by that time;
  • Document infant vaccination accurately in birth hospital records and in the appropriate CDC Immunization Information Systems and state immunization registry. Review documentation accuracy periodically and address identified errors.

What resources are available for talking to families about the hepatitis B vaccine birth dose?

Last Updated

01/02/2026

Source

American Academy of Pediatrics