Why the Birth Dose Matters for Hepatitis B Vaccination

Recently, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices repealed the long-standing recommendation for universal hepatitis B vaccination at birth and moved to a high risk based/shared clinical decision-making recommendation. This is very concerning due to historical data demonstrating worse outcomes with a risk-based model. This decision further sows distrust in pediatric vaccinations with the potential to cause irreparable harm. The Pediatric Pharmacy Association recommends continuation of the universal hepatitis B birth dose vaccine strategy to provide an optimal protection strategy for all infants.

In December 2025, the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to modify the recommendations for hepatitis B vaccination of certain infants.¹ Which was then further modified by the Deputy Secretary of Health and Human Services and Acting Director of the CDC, in January 2026, stating that the hepatitis B vaccine is only routinely recommended for high-risk populations.^2,3 Specifically, these actions resulted in a change from a universal routine recommendation of all newborns beginning a 3-dose series at birth (0, 1–2, and 6–18 months) to a recommendation based on maternal hepatitis B antigen (HBsAG) status.^1,4 (In a previous meeting, ACIP recommended universal hepatitis B screening during pregnancy, although this has been routine practice since 1988.⁵) Under their new recommendation, it would now be advised that all infants born to infected (HBsAG-positive) or unknown persons would continue to receive the hepatitis B vaccine at birth, while those who are born to uninfected-persons would need to decide via individual or shared clinical decision (referred to as shared clinical decision from now on) to receive the vaccine at birth, 2 months, or not at all.^1–3 Finally, ACIP made a recommendation for serology testing following initial dosing. The Pediatric Pharmacy Association recommends continuation of the universal hepatitis B vaccine birth strategy to prevent unnecessary increased risk of life-long hepatitis B infection in infants that are delayed or unvaccinated against hepatitis B disease.

Hepatitis B Virus and Chronic Disease in Pediatrics

Newborns and children under 5 years old infected with hepatitis B are more likely to develop chronic hepatitis disease than infected adults. Rates of chronic infection approach 90% in newborns, 25% to 30% in infants and young children, and only 5% in adults.⁶ The CDC data suggest that 25% of these young patients with chronic hepatitis B disease in early life will die prematurely due to a Hepatitis B related complication (e.g., liver disease, liver cancer).⁷

Although perinatal transmission is the major pathway for pediatric hepatitis B disease, not all transmission is via this route. Hepatitis B can also be transmitted horizontally or through exposure to blood or other bodily fluids. This risk is amplified as up to 50% of individuals who are infected with hepatitis B in the United States are unaware that they are infected.⁷ That along with the hepatitis B virus’ ability to remain viable in environmental conditions for at least a week (likely longer), placing unvaccinated young children at risk for potential horizontal infection.^8,9 Data from pre-universal hepatitis B infant vaccination era indicated that 46% to 68% of pediatric hepatitis B cases were not caused by perinatal transmission, with the proportion of horizontally acquired disease increasing with age.^10,11 In addition, there is concern that decline in vaccination rates would lead to higher community transmission of hepatitis B, increasing infection risk in those who either remained unvaccinated or had delayed vaccination.

The 3-dose hepatitis B series initiated at birth is highly effective for preventing both perinatal and horizontal transmission. Individuals who demonstrate seroconversion defined as an antibody to the hepatitis B surface antigen (anti-HBs) concentration of ≥10 mIU/mL after receiving the full hepatitis B series are considered immune.¹² If the individual was not tested after completing the series and is now considered high risk (or for some immunocompromised groups), seroconversion testing is recommended. In these cases, it is recommended to provide a challenge dose to ensure that they do have protection. Over 90% of individuals demonstrated protection about 20 years after completing vaccination, when a challenge dose was administered.^13,14 Further, long term follow-up (median 33 years) outcome data from over 80,000 individuals in China, suggests that a 3-dose hepatitis B series has resulted in 72% (95% CI: 30–89) protective efficacy liver cancer and 64% (95% CI: 27–82) overall liver disease related mortality.¹⁵

Historical Failure of Risk-Based Vaccination

Although vaccinating infants who are likely to be exposed via maternal infection or unknown maternal status appears to be reasonable, it is something the United States implemented for hepatitis B vaccination, decades earlier, that resulted with poor outcomes. From 1986 to 1990, the rate of acute hepatitis B in children (1–9 years) was between 0.7 to 0.9 per 100,000 population.⁵ This rate did not decline significantly, despite recommendations that high-risk pregnant individuals (1984), followed by all pregnant individuals, undergo routine hepatitis B screening (1988). As well as the implementation of hepatitis B vaccine and immune globulin to be administered at birth to all infants born to hepatitis B positive mothers (1988).⁵ Universal routine infant hepatitis B vaccination was implemented in 1991; by 2000, the rate of hepatitis B disease in children had declined to 0.1 per 100,000 population.⁵ A Norwegian study evaluated the uptake of vaccination of targeted vaccination against both hepatitis B and tuberculosis based on risk and compared vaccine uptake in those at risk to rates in the same population for universally recommend vaccines (i.e., pertussis, measles). Researchers determined that vaccine coverage was lower for those at risk for hepatitis B or tuberculosis (uptake percent in at risk infants 90% hepatitis B, 83.6% tuberculosis) compared with routine vaccine (98.6% uptake pertussis and 92.3% uptake measles vaccine) in the high-risk groups.¹⁶

The changes to the vaccine schedule made in January 2026 by the US Department of Health and Human Services follow Denmark’s schedule.^3,17 The comparisons to Denmark and other international approaches may be misleading due to differences in infection rates, access to care, screening availability, documentation and ability to confirm follow up through structural safeguards.^17,18 The most recent US data suggest that as many as 2.4 million individuals have hepatitis B compared with only 133 individuals in Denmark.^7,19 Other important differences are that in the United States, it is estimated that half of the individuals infected are unaware. In Denmark they also have strong screening systems, whereas about 15% of all pregnant women are not screened.^5,20 So in most countries including the United States, it is important to ensure timely protection. The World Health Organization reinforced this position in February 2025.²¹ Based on the data, an increasing number of countries (112 in 2024) world-wide have adopted universal hepatitis B birth doses.^17,22

Timing of the Vaccination

The hepatitis B birth dose has been extensively studied for over decades and has demonstrated a strong safety and efficacy profile.^7,12,23,24 There is no specific data suggesting that vaccinating infants at 2 months of age would be safer than vaccinating them at birth. Routine testing has high sensitivity and specificity for most strains of hepatitis B, however many tests have failed to detect escape mutant strains of hepatitis B.^25,26 Thus, if a test has a false-negative maternal result, deferring the first vaccine dose eliminates a critical layer of protection during a period of high susceptibility, placing the infant at risk for infection and subsequent lifelong chronic disease.

Vaccine Safety

The safety of infant and pediatric hepatitis B vaccination has been demonstrated over multiple decades. Comparator studies between vaccinated and unvaccinated infants have demonstrated no association with infant mortality, sepsis, febrile events, seizure, or development of multiple sclerosis.^23,24,27

Seroconversion Testing

Seroconversion testing has been shown to be effective and is recommended for infants that have been exposed via vertical transmission after completing the series between 9 and 12 months of age.^4,28,29 There is no evidence that having anti-HBs concentration of ≥10 mIU/mL after 1 or 2 doses of a 3-dose series will provide long-term protection.³⁰ Until evidence is available, experts do not agree with the recommendation to obtain serology testing of those who have not completed the series.³¹

What Is Shared Clinical Decision Making for Vaccines?

It is important to understand the intent and limitations of shared clinical decision-making recommendation for vaccines. First, for all childhood vaccinations whether through universal recommendation or shared clinical decision, the benefits and risks of the vaccines must be discussed with the parents. Parents are provided with the Vaccine Information Sheets, and should be asked to provide informed consent prior to vaccine administration (in many states this is required). What is different about shared clinical decision recommendations (historically called B-level recommendation) is that they have traditionally been reserved for situations where it may provide individual benefit, but it is unlikely to make a population-level impact.³² The CDC makes it clear that health care providers, including pharmacists, are included in the group who can and should have these conversations with parents. It also has been determined that any recommendation, routine or shared clinical decision, are required to be covered by insurance.³²

Although ACIP’s shift away from a universal infant hepatitis B to a high-risk approach combined with shared clinical decision vaccine does not technically decrease access, it causes confusion, sets up multiple workflows, and increases the likelihood of missed doses and opportunities. Media headlines and social media summaries often compress complex policy into oversimplified or inaccurate statements (e.g., “CDC votes against the HepB birth dose” or “CDC votes against HepB”), frequently omitting the nuance that the discussion pertains to timing of infant vaccination rather than vaccine safety or effectiveness. Such framing risks destroying public and clinician confidence by implying that the vaccine itself is being withdrawn or deemed unsafe. This type of messaging can amplify uncertainty, fuel misinformation, and create avoidable hesitancy among families and even clinicians. The impact of a similar change to the 13-valent pneumococcal vaccine in 2019 that was made for adults 65 years and older while awaiting the approval of the new pneumococcal vaccines was evaluated. For that vaccine, a survey of physicians noted 76% agreed (e.g., either strongly agreed or somewhat agreed) the change in the recommendation would cause confusion and 83% agreed it would result in fewer patients receiving the vaccine.³³ More concerning is this same study noted that 60% of physicians responded they did not know what to emphasize when having the conversations with their patients regarding the recommendation.³³ This decrease in vaccine uptake is being seen currently with COVID-19 vaccination of children. COVID-19 vaccination was already very low in children (6 months–17 years) at 9% in 2024–2025. With the delay in the recommendation and change to a shared clinical decision recommendation only 5% of children have been vaccinated in fall/winter 2025.³⁴ Recent data suggest that despite a universal routine birth dose recommendations, only 76% of babies receive a hepatitis B vaccine dose within 24 hours of birth.³⁵ Despite having a routine recommendation in place since 1988 to screen all pregnant women for hepatitis B infection, data show that from 2015–2020, only 84% to 86% of pregnant women were tested.^5,20 Pham et al²⁰ noted those who were Asian, college educated, at least 20 years old, or had previous children were more likely to be screened, this leaves out many high-risk populations.

As front-line providers, pediatric pharmacists are relied upon as a source of education for parents who are seeking guidance. First, note that only the CDC recommendations are changing, the American Academy of Pediatrics and American Family Physician immunization schedules have not changed.^28,29,31 There are no changes to the efficacy assessment, nor have any new adverse effects or safety concerns with the infant hepatitis B vaccine been discovered.³¹

It is important to educate the parents about hepatitis B virus, their infant’s risk of hepatitis B infection, as well as the efficacy and safety of the vaccine. Even those who are hepatitis B positive may not understand the importance of vaccination.