What are the risks and benefits of vaccinating a newborn against Hepatitis B (HBV)?

From the Guidelines

Vaccinating newborns against hepatitis B is strongly recommended, as the benefits of preventing hepatitis B infection, promoting long-lasting immunity, and reducing mother-to-child transmission far outweigh the risks of mild side effects and rare severe allergic reactions. The hepatitis B vaccine is a crucial component of newborn care, and its administration at birth is a cost-effective medical intervention that offers a high benefit-cost ratio 1.

Benefits of vaccinating newborns against hepatitis B include:

• Preventing hepatitis B infection, which can lead to chronic liver disease and cancer
• Providing long-lasting immunity, with approximately 95% of healthy infants responding to the vaccine series 1
• Helping prevent mother-to-child transmission, which is a significant risk factor for chronic hepatitis B infection
• Contributing to community immunity, which reduces the spread of the virus

Risks associated with the hepatitis B vaccine are:

• Mild side effects, such as soreness at the injection site and low-grade fever
• Very rare severe allergic reactions, which occur in less than 1 in a million doses

The vaccine is typically given as a series of 3-4 doses:

1. At birth (within 24 hours)
2. At 1-2 months
3. At 6-18 months
4. Sometimes an additional dose for high-risk infants, such as those born to HBsAg-positive mothers

The vaccine is safe and effective, containing a small part of the hepatitis B virus that cannot cause infection but stimulates the immune system to produce antibodies, providing lifelong protection in most cases 1. Early vaccination is crucial because infants who become infected have a 90% chance of developing chronic hepatitis B, compared to only 5% in adults. By vaccinating at birth, we protect infants during their most vulnerable period. Additionally, the administration of both the vaccine and hepatitis B immunoglobulin (HBIG) to newborns of HBeAg-positive mothers within 12-24 hours of birth allows for the achievement of a 90% protection rate 1.

From the FDA Drug Label

For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%–95% effective in preventing development of the HBV carrier state. Hepatitis B Vaccine should be administered IM in three doses of 0. 5 mL of vaccine (10 μg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immune Globulin (Human) but at a separate site.

The benefits of vaccinating a newborn against Hepatitis B (HBV) include:

• Prevention of development of the HBV carrier state in 85%–95% of cases when the vaccine is administered in combination with Hepatitis B Immune Globulin (Human) at birth
• Long-term protection against HBV infection The risks of vaccinating a newborn against Hepatitis B (HBV) are not explicitly stated in the provided drug labels, but the administration of the vaccine is generally considered safe when given according to the recommended schedule and dosage. 2 2

From the Research

Risks of Vaccinating a Newborn against Hepatitis B (HBV)

• The risks associated with vaccinating a newborn against HBV are relatively low, with most adverse events being minor and self-limiting, such as injection site reactions, temperature instability, and cardiorespiratory events 3.
• Serious adverse events, such as the requirement for escalation of respiratory support, are rare (~1%) and occur predominantly in high-risk infant populations 3.
• Preterm infants may have a lower median seroprotection proportion compared to term infants, especially if vaccinated at 0-3 days of age 4.

Benefits of Vaccinating a Newborn against Hepatitis B (HBV)

• Vaccinating newborns against HBV can provide high levels of protection, effectively preventing transmission of HBV and resultant morbidity and mortality 4, 5.
• Universal vaccination against HBV can lead to a significant reduction in the chronic carrier rate and transmission of the virus 5.
• Newborn and infant HBV vaccination programs can have a sustained impact on global HBV incidence, even if they have a delayed impact on sexual transmission of HBV 5.
• Long-term protection against HBV after newborn vaccination has been demonstrated, with persistent protection up to adolescence despite a frequent waning of anti-HBs antibodies 6.

Considerations for Preterm Infants

• There is limited information on the safety of the hepatitis B vaccine in preterm infants, whose immune responses and morbidity risk differ from those in infants born at term 3.
• Research focusing on the safety of hepatitis B vaccine in preterm infants specifically within 7 days of birth is lacking, particularly regarding long-term morbidity risk 3.
• Preterm infants with birth weights <2000g may have lower median seroprotection proportions compared to those with birth weights ≥2000g 4.