Hepatitis B Vaccine in America 2025
The hepatitis B vaccine landscape in the United States during 2025 represents a critical juncture in public health policy and disease prevention. The vaccine, introduced in the early 1980s and expanded to universal infant vaccination in 1991, has fundamentally transformed the epidemiology of hepatitis B virus (HBV) infection across American communities. Current data reveals that while remarkable progress has been achieved in reducing pediatric infections, challenges persist in adult vaccination coverage and emerging policy debates surrounding the birth dose recommendation.
The present state of hepatitis B vaccination in the US in 2025 encompasses multiple dimensions, including universal infant vaccination recommendations, expanded adult vaccination guidelines introduced in 2022 targeting all adults aged 19-59 years, and ongoing surveillance through the Perinatal Hepatitis B Prevention Program (PHBPP). With an estimated 850,000 to 2.4 million Americans living with chronic hepatitis B infection, the vaccine remains the most effective tool for preventing transmission and reducing the burden of liver-related complications including cirrhosis and hepatocellular carcinoma.
Key Facts About Hepatitis B Vaccine in the US 2025
| Fact Category | 2025 Statistics |
|---|---|
| Licensed Vaccine Products | 3 single-antigen vaccines: Engerix-B (GSK), Recombivax HB (Merck), Heplisav-B (Dynavax); 3 combination vaccines: Pediarix, Vaxelis, Twinrix |
| Universal Birth Dose Policy | Recommended for all medically stable newborns within 24 hours of birth since 1991 |
| Current Birth Dose Coverage | Approximately 80% of US newborns receive hepatitis B vaccine at birth |
| Perinatal Cases 2023 | 7 perinatal hepatitis B cases reported through NNDSS in 2023 |
| Historic Reduction | 95% decline in pediatric hepatitis B infections since 1991 universal vaccination |
| Adult Vaccination Recommendation | Universal vaccination for all adults aged 19-59 years (updated 2022) |
| WHO Member States with Birth Dose | 115 of 194 WHO countries adopted birth dose policy by 2024 |
| Vaccine Series Completion | 3-dose series (Engerix-B, Recombivax HB) or 2-dose series (Heplisav-B for adults 18+) |
| Vaccine Effectiveness | 85-95% effective when combined with HBIG for perinatal prevention |
| PreHevbrio Recall | Voluntary recall initiated November 2024 due to manufacturer restructuring |
Data Source: CDC Hepatitis B Vaccine Administration Guidelines, September 2025; CDC 2023 Viral Hepatitis Surveillance Report, April 2025; ACIP Meeting Documents, September 2025
The data demonstrates that three single-antigen hepatitis B vaccines currently protect Americans from HBV infection, with Engerix-B and Recombivax HB approved for use from birth and Heplisav-B approved for adults 18 years and older. The universal birth dose policy implemented in 1991 has successfully reduced perinatal transmission to just 7 cases reported nationwide in 2023, representing one of the most significant vaccine-preventable disease achievements in recent American public health history. However, the 80% birth dose coverage rate indicates approximately one in five newborns do not receive timely vaccination, leaving a concerning gap in protection. The 2022 expansion of adult vaccination recommendations to include all adults aged 19-59 years reflects recognition that risk-based vaccination strategies were insufficient to control hepatitis B transmission in adult populations.
The 95% reduction in pediatric hepatitis B infections since 1991 underscores the transformative impact of universal infant vaccination, preventing an estimated 6 million hepatitis B infections and nearly 1 million hospitalizations among children born between 1994 and 2023. The availability of 115 WHO member states implementing birth dose vaccination globally demonstrates international consensus on the importance of early immunization. The November 2024 recall of PreHevbrio vaccine due to manufacturer VBI Vaccines’ bankruptcy, while representing a supply disruption, does not reflect safety concerns and patients can seamlessly transition to other licensed products to complete their vaccination series.
Hepatitis B Disease Burden in the US 2025
| Disease Burden Indicator | 2023-2025 Data |
|---|---|
| Acute Hepatitis B Cases Reported 2023 | 2,214 cases from 47 states and DC |
| Estimated Acute Infections 2023 | 14,400 infections after adjusting for underreporting |
| Newly Reported Chronic Cases 2023 | 17,650 cases from 44 states and DC |
| Chronic Case Rate 2023 | 6.1 cases per 100,000 population |
| Hepatitis B-Related Deaths 2023 | 1,769 deaths |
| Death Rate 2023 | 0.44 deaths per 100,000 population |
| Estimated Chronic Infections in US | 850,000 to 2.4 million people |
| Unaware of Infection | Approximately 50% of those with chronic hepatitis B |
| Asian/Pacific Islander Chronic Rate | 18.9 cases per 100,000 population (9.9 times higher than non-Hispanic White) |
| Peak Age Groups for Chronic Cases | Ages 30-39 and 40-49 (combined 46% of all chronic cases) |
Data Source: CDC 2023 Viral Hepatitis Surveillance Report, Published April 2025; CDC National Vital Statistics System 2023; CDC Viral Hepatitis National Progress Report 2024
The hepatitis B disease burden in the United States during 2023-2025 reveals persistent challenges despite decades of vaccination efforts. The 2,214 acute hepatitis B cases reported in 2023 represents significant underascertainment, with epidemiological adjustments estimating the true number at 14,400 acute infections when accounting for asymptomatic cases and incomplete reporting. The chronic hepatitis B picture proves even more substantial, with 17,650 newly reported chronic cases in 2023 adding to the existing reservoir of infected individuals. The 6.1 cases per 100,000 population rate for chronic hepatitis B demonstrates ongoing transmission occurring primarily among unvaccinated adults.
Hepatitis B mortality data from 2023 documents 1,769 deaths attributed to the virus, translating to an age-adjusted death rate of 0.44 per 100,000 population. This death rate remained relatively stable from 2021-2023 after initial increases during the pandemic period, though it exceeds the 2025 target of 0.37 deaths per 100,000, indicating progress toward viral hepatitis elimination goals has stalled. The estimated 850,000 to 2.4 million Americans living with chronic hepatitis B infection, with approximately 50% unaware of their status, represents a substantial hidden reservoir of infection capable of ongoing transmission and future liver disease complications.
The racial and ethnic disparities in hepatitis B burden remain stark and alarming. Asian/Pacific Islander persons experience chronic hepatitis B at a rate of 18.9 cases per 100,000 population, a rate 9.9 times higher than the 1.9 cases per 100,000 observed among non-Hispanic White persons. This 14:1 rate disparity ratio represents one of the most severe health equity gaps in infectious disease epidemiology and reflects historical patterns of immigration from hepatitis B-endemic regions combined with perinatal and early childhood transmission before widespread vaccination. The concentration of 46% of chronic hepatitis B cases in adults aged 30-49 years demonstrates that individuals born before or during the early implementation of universal infant vaccination bear the greatest disease burden, having missed the protection that younger birth cohorts now enjoy.
Hepatitis B Vaccination Coverage Rates in the US 2025
| Population Group | Vaccination Coverage 2025 |
|---|---|
| Birth Dose Coverage | Approximately 80% of newborns receive vaccine within 24 hours |
| Children 19-35 Months (≥3 Doses) | 90%+ coverage maintained since 2003 |
| Children 19-35 Months (Birth Dose) | 72.4% received birth dose by 3 days of life (2014 data) |
| Adolescents 13-17 Years | 91.4% have completed hepatitis B series |
| Adults ≥19 Years (≥3 Doses) | 24.5% vaccination coverage |
| Adults 19-49 Years | 32.2% vaccination coverage |
| Adults ≥50 Years | 15.7% vaccination coverage |
| Healthcare Personnel Overall | 63.4% received ≥3 doses; 69.5% received ≥1 dose |
| HCP with Direct Patient Contact | 74.0% received ≥3 doses; 80.7% received ≥1 dose |
| Adults with Diabetes (19-59 Years) | 23.5% vaccination coverage |
Data Source: National Immunization Survey 2014-2022; CDC Viral Hepatitis Epidemiology Studies; National Health Interview Survey 2014; WHO Hepatitis B Immunization Data 2022
Hepatitis B vaccination coverage in the United States demonstrates a clear generational divide between high pediatric coverage and suboptimal adult vaccination rates. The approximately 80% birth dose coverage rate indicates that while the majority of American newborns receive timely protection, a significant 20% gap persists, leaving vulnerable infants at risk for perinatal and early childhood transmission. Among children aged 19-35 months, coverage with three or more doses has consistently exceeded 90% since 2003, reflecting successful integration of hepatitis B vaccine into routine childhood immunization schedules.
The 72.4% birth dose coverage by 3 days of life measured in 2014 suggests opportunities remain to improve timely administration, as delayed vaccination increases the window for potential transmission from unrecognized maternal infections or household exposures. Adolescent coverage at 91.4% for ages 13-17 years demonstrates sustained protection through school entry requirements and catch-up vaccination programs, ensuring that young people entering higher-risk behaviors have established immunity before potential exposure.
Adult hepatitis B vaccination coverage presents a stark contrast to pediatric success, with only 24.5% of adults aged 19 years and older having received the complete vaccine series. This low coverage rate directly contributes to ongoing adult hepatitis B transmission and explains why the disease burden has shifted from children to unvaccinated adults. Coverage improves slightly among younger adults (32.2% for ages 19-49) compared to older adults (15.7% for ages 50 and above), but remains far below the levels needed to achieve population immunity.
Among healthcare personnel, vaccination coverage reaches 63.4% for the complete series and 69.5% for at least one dose, with higher rates (74.0% and 80.7% respectively) among those with direct patient contact. While these rates exceed general population coverage due to OSHA requirements and occupational health programs, they still indicate substantial numbers of healthcare workers remain vulnerable to occupational HBV exposure. The particularly low 23.5% coverage among adults with diabetes aged 19-59 years is concerning given their elevated infection risk and demonstrates failure of risk-based vaccination strategies.
Perinatal Hepatitis B Prevention Program in the US 2025
| PHBPP Indicator | 2022 Birth Cohort Data |
|---|---|
| Infants Born to HBsAg+ Mothers | 7,327 infants managed by PHBPP from 64 jurisdictions |
| Received PEP at Birth | 92% received hepatitis B vaccine and HBIG within 12 hours |
| Completed 3-Dose Vaccine Series | 86% completed series by age 12 months |
| Received Post-Vaccination Testing | 65% received recommended testing at 9-12 months |
| Perinatal Infections Identified | 7 cases of perinatal hepatitis B (0.15% of tested infants) |
| Estimated HBsAg+ Pregnant Women | Approximately 0.5% of pregnant women test positive (estimated 17,827 infants born to HBsAg+ mothers in 2021) |
| Prenatal Screening Coverage | Universal screening recommended but national registry absent |
| Historical Perinatal Cases | Declined from 1,600 cases in early 1990s to <20 cases in recent years |
Data Source: CDC Perinatal Hepatitis B Prevention Program 2022 Birth Cohort; CDC 2023 Viral Hepatitis Surveillance Report; CDC PHBPP National Data
The Perinatal Hepatitis B Prevention Program represents one of the most successful targeted intervention programs in American public health, dramatically reducing mother-to-child transmission of hepatitis B. The 2022 birth cohort data documents that 7,327 infants born to mothers with hepatitis B infection were identified and case-managed through the program across 64 jurisdictions including all 50 states, the District of Columbia, five major cities, and territories. The 92% rate of infants receiving appropriate post-exposure prophylaxis (both hepatitis B vaccine and HBIG) within the critical 12-hour window after birth demonstrates excellent adherence to clinical guidelines.
The 86% series completion rate by age 12 months indicates most exposed infants receive the full protective vaccine series, though the 14% gap represents missed opportunities for establishing immunity. More concerning is the 65% post-vaccination testing rate, as serologic testing at 9-12 months of age is essential for identifying the small proportion of infants who become infected despite prophylaxis or who fail to mount adequate immune responses. The 35% of infants who do not receive recommended testing may harbor undetected chronic infections that will only manifest when liver complications develop years or decades later.
Among the 4,729 infants in the 2022 cohort who received post-vaccination testing, 7 cases of perinatal hepatitis B infection were identified, representing an infection rate of just 0.15%. This remarkably low rate demonstrates the 95% effectiveness of the combined vaccine and HBIG prophylaxis strategy. The dramatic decline from approximately 1,600 perinatal cases in the early 1990s to fewer than 20 cases in recent years represents a 98-99% reduction in perinatal transmission, preventing chronic infections that carry a 25% lifetime risk of premature death from liver disease or cancer.
The estimated 0.5% prevalence of hepatitis B surface antigen positivity among pregnant women translates to approximately 17,827 infants born to infected mothers annually based on 2021 data. However, significant gaps exist in prenatal screening, with some pregnant women not receiving timely testing and some positive cases not being reported to public health programs. The absence of a national registry to track hepatitis B screening in pregnant women, unlike 32 of 38 selected comparison countries including most high-income nations, limits the ability to ensure universal screening and appropriate infant case management.
Acute Hepatitis B Cases in the US 2025
| Acute HBV Characteristic | 2023 Statistics |
|---|---|
| Reported Acute Cases 2023 | 2,214 cases from 47 states and DC |
| Estimated Actual Infections | 14,400 acute infections after adjustment |
| Underreporting Factor | Approximately 6.5:1 (actual to reported) |
| Age Distribution (Acute Cases) | 73% occur in adults aged 30-59 years |
| Primary Risk Behaviors Reported | 35% injection drug use; 23% multiple sex partners |
| Missing Risk Information | 37.1% of cases lack risk behavior data |
| Geographic Distribution | Highest rates in eastern and southeastern US, particularly Appalachian region |
| Trend 2015-2019 | Approximately 20,000 infections annually (stable) |
| Trend 2020-2023 | Decreased in 2020, remained stable 2021-2023 |
| Opioid-Impacted States | 114% increase in cases from 2006-2013 in KY, TN, WV |
Data Source: CDC 2023 Viral Hepatitis Surveillance Report; CDC National Notifiable Diseases Surveillance System; CDC MMWR Universal Adult Hepatitis B Vaccination 2022
Acute hepatitis B case data from 2023 reveals ongoing transmission patterns concentrated in specific risk groups and geographic regions. The 2,214 reported acute cases substantially underestimate the true burden, as many acute infections are asymptomatic or unreported. CDC epidemiological modeling adjusts this to 14,400 estimated actual acute infections, indicating an underreporting factor of approximately 6.5:1. This significant gap between reported and estimated cases underscores challenges in hepatitis B surveillance and the substantial number of infections going undetected in real-time.
The age distribution of acute cases demonstrates that 73% occur among adults aged 30-59 years, the demographic that largely missed universal infant vaccination implemented in 1991 and for whom previous risk-based vaccination recommendations proved insufficient. This concentration of disease burden in working-age adults represents both a public health challenge and an economic burden through lost productivity and healthcare costs. The shift in hepatitis B epidemiology from children (pre-1991) to unvaccinated adults validates the success of pediatric vaccination while highlighting the urgent need for improved adult vaccination coverage.
Risk behavior analysis among acute cases identifies injection drug use as the leading reported exposure (35% of cases), followed by multiple sexual partners (23%), and surgery (10%). The 37.1% of acute cases with missing or unreported risk information complicates targeted prevention efforts and may reflect patient reluctance to disclose stigmatized behaviors, inadequate risk assessment by healthcare providers, or genuine uncertainty about transmission sources. The prominence of injection drug use as the primary driver reflects the ongoing opioid and substance use crisis affecting American communities.
Geographic analysis reveals acute hepatitis B rates are highest in states primarily located in the eastern and southeastern United States, particularly in or near the Appalachian region spanning parts of Kentucky, Tennessee, West Virginia, Virginia, and surrounding states. This geographic clustering directly correlates with areas experiencing high rates of injection drug use related to the opioid epidemic. Historical data documents a 114% increase in acute hepatitis B cases from 2006-2013 in Kentucky, Tennessee, and West Virginia, demonstrating how substance use epidemics drive infectious disease transmission. After remaining relatively stable at approximately 20,000 infections annually from 2015-2019, acute hepatitis B decreased in 2020 coinciding with pandemic-related disruptions and remained relatively stable through 2021-2023.
Chronic Hepatitis B Cases in the US 2025
| Chronic HBV Indicator | 2023-2025 Data |
|---|---|
| Newly Reported Chronic Cases 2023 | 17,650 cases from 44 states and DC |
| National Chronic Case Rate | 6.1 cases per 100,000 population |
| Estimated Total Chronic Infections | 850,000 to 2.4 million people in the US |
| Unaware of Chronic Infection | Approximately 50% (about 67% among those with HBV) |
| Foreign-Born Proportion | Estimated 70% of chronic HBV infections |
| Asian/Pacific Islander Rate | 18.9 cases per 100,000 (27.0 in earlier reports) |
| Non-Hispanic Black Rate | 10.8% prevalence in population studies |
| Non-Hispanic White Rate | 1.9 cases per 100,000 (baseline comparison) |
| Hispanic Rate | 3.8% prevalence in population studies |
| Rate Disparity Ratio | 9.9:1 (Asian/Pacific Islander vs. non-Hispanic White) |
| Peak Age Groups | Ages 30-39 and 40-49 combined account for 46% of cases |
Data Source: CDC 2023 Viral Hepatitis Surveillance Report; NHANES 2013-2018 Prevalence Data; CDC Hepatitis B Epidemiology Publications
Chronic hepatitis B represents the most significant long-term public health burden of HBV infection in the United States. The 17,650 newly reported chronic cases in 2023 from 44 states and DC translates to a national rate of 6.1 cases per 100,000 population, though this figure represents only a fraction of total prevalent cases. Population-based surveillance estimates between 850,000 and 2.4 million Americans currently live with chronic hepatitis B infection, with the wide range reflecting methodological challenges in estimating prevalence among underrepresented populations including undocumented immigrants and individuals from hepatitis B-endemic regions.
The finding that approximately 50% of people with chronic hepatitis B remain unaware of their infection status represents a critical gap in disease control efforts. Undiagnosed individuals cannot benefit from antiviral treatment that prevents disease progression, may unknowingly transmit infection to close contacts including newborns and sexual partners, and often present to medical care only after developing advanced cirrhosis or hepatocellular carcinoma. The estimate that 67% of those with HBV are unaware specifically underscores how this largely asymptomatic infection evades detection without proactive screening.
The demographic composition of chronic hepatitis B in the United States reflects historical immigration patterns and perinatal transmission in endemic regions. An estimated 70% of chronic HBV infections occur among foreign-born persons who acquired infection in their countries of origin, predominantly through perinatal or early childhood exposure. Asian/Pacific Islander persons bear a disproportionate burden with 18.9 newly reported cases per 100,000 population in 2023, representing a rate 9.9 times higher than the 1.9 cases per 100,000 among non-Hispanic White persons. This rate disparity ratio of 9.9:1 ranks among the most severe health equity gaps in infectious disease epidemiology.
Additional population-based studies document 10.8% prevalence among non-Hispanic Black persons and 3.8% prevalence among Hispanic persons compared to 2.1% among non-Hispanic White persons, revealing persistent racial and ethnic disparities that require culturally tailored screening, linkage to care, and vaccination strategies. The concentration of 46% of newly reported chronic cases in adults aged 30-49 years reflects the generation born before or during early implementation of universal infant vaccination who remain vulnerable to infection through adult risk behaviors including injection drug use and unprotected sexual contact.
Hepatitis B Mortality in the US 2025
| Mortality Indicator | 2023 Statistics |
|---|---|
| Total Hepatitis B Deaths 2023 | 1,769 deaths where HBV listed as cause |
| Age-Adjusted Death Rate 2023 | 0.44 deaths per 100,000 population |
| 2025 Target Goal | 0.37 deaths per 100,000 population |
| Gap to Meet Goal | 16% reduction needed from 2023 rate |
| Death Rate Trend 2013-2019 | Decreased from 0.53 to 0.42 per 100,000 |
| Death Rate 2020 | Increased to 0.45 per 100,000 |
| Death Rate 2021-2023 | Relatively stable at 0.44 per 100,000 |
| Asian/Pacific Islander Death Rate | 2.30 deaths per 100,000 (5.2 times national rate) |
| Hawaii Death Rate | 1.24 per 100,000 (highest among states) |
| States with Highest Rates | California, Hawaii, Maryland, Minnesota, Nevada, Oklahoma, Oregon |
Data Source: CDC National Vital Statistics System 2023; CDC 2023 Viral Hepatitis Surveillance Report; CDC Viral Hepatitis National Progress Report 2024
Hepatitis B mortality data from 2023 documents 1,769 deaths with hepatitis B listed as either the underlying or a contributing cause of death on death certificates, translating to an age-adjusted death rate of 0.44 per 100,000 population. While this rate remained relatively stable from 2021-2023, it exceeds the 2025 target goal of 0.37 deaths per 100,000, requiring a 16% reduction from current levels to meet elimination objectives. The failure to achieve annual targets indicates that progress toward viral hepatitis elimination has stalled, and more aggressive strategies are needed to link diagnosed individuals to antiviral treatment and prevent liver disease progression.
Historical trends show hepatitis B mortality declined from 0.53 deaths per 100,000 in 2013 to 0.42 deaths per 100,000 in 2019, demonstrating gradual progress in reducing fatal outcomes through improved screening, treatment, and vaccination. However, the death rate increased to 0.45 per 100,000 in 2020 coinciding with pandemic-related healthcare disruptions, then plateaued at 0.44 per 100,000 from 2021-2023 rather than continuing its previous downward trajectory. This stagnation suggests the pandemic’s impact on routine screening, care engagement, and treatment adherence continues to affect hepatitis B outcomes.
Profound racial and ethnic disparities characterize hepatitis B mortality, with Asian/Pacific Islander persons experiencing an age-adjusted death rate of 2.30 per 100,000 in 2022, 5.2 times the national average of 0.44 per 100,000. This disparity reflects the high chronic infection prevalence in Asian/Pacific Islander communities combined with cultural and linguistic barriers to accessing treatment, lower rates of antiviral therapy utilization, and later-stage diagnosis when cirrhosis or liver cancer has already developed. Geographic analysis identifies Hawaii with the highest state-level death rate at 1.24 per 100,000, followed by California, Maryland, Minnesota, Nevada, Oklahoma, and Oregon, generally correlating with states having large Asian immigrant populations or significant injection drug use-related infections.
The burden of liver-related mortality among people with chronic hepatitis B extends beyond deaths explicitly coded to hepatitis B on death certificates. Population-based studies estimate all-cause mortality among those with chronic HBV at 21.4 per 1,000 person-years compared to 11.8 per 1,000 person-years among uninfected individuals, representing a 1.9-fold increased hazard of death. More strikingly, liver-related mortality occurs at 4.1 per 1,000 person-years among chronically infected persons versus just 0.1 per 1,000 person-years among the uninfected, a 13.3-fold increased hazard that underscores how hepatitis B directly drives premature death through cirrhosis and hepatocellular carcinoma.
Adult Hepatitis B Vaccination Recommendations in the US 2025
| Adult Vaccination Policy | Current Recommendations 2025 |
|---|---|
| Universal Adult Vaccination Age Range | All adults aged 19-59 years (updated 2022) |
| Adults 60+ with Risk Factors | Adults 60 years and older with HBV risk factors |
| Adults 60+ Without Known Risk | May receive vaccination at discretion |
| Previous Risk-Based Criteria | Replaced universal recommendation due to suboptimal coverage |
| Healthcare Worker Vaccination | Required by OSHA for occupational exposure |
| Dialysis Patient Schedule | High-dose 40 mcg formulation on specialized schedule |
| Pregnancy Vaccination | Engerix-B, Heplisav-B, Recombivax HB, Twinrix approved |
| Implementation Date | Recommendations published April 2022, effective immediately |
| Previous Coverage with Risk-Based | Only 24.5% of adults 19+ had completed series |
| Rationale for Change | Remove barriers from risk assessment/disclosure requirements |
Data Source: CDC MMWR Universal Adult Hepatitis B Vaccination 2022; ACIP Adult Immunization Schedule 2025; CDC Hepatitis B Vaccine Administration Guidelines
The Advisory Committee on Immunization Practices (ACIP) fundamentally restructured adult hepatitis B vaccination recommendations in 2022 by expanding from risk-based to universal vaccination for all adults aged 19-59 years. This landmark policy change recognizes that previous risk-based strategies, which required healthcare providers to assess individual risk factors and patients to disclose potentially stigmatized behaviors, achieved insufficient coverage to control adult hepatitis B transmission. Under the 2022 updated recommendations, all adults in the 19-59 age range should receive hepatitis B vaccination regardless of risk factors, while adults 60 years and older with identified risk factors should be vaccinated and those without known risks may opt for vaccination based on individual circumstances and provider discussion.
The evidence supporting universal adult vaccination includes the persistently low 24.5% coverage achieved under risk-based recommendations among adults aged 19 years and older, improving only modestly to 32.2% among adults 19-49 years and dropping to just 15.7% among those 50 years and older. These coverage rates proved inadequate to reduce adult hepatitis B incidence, which remained stable at approximately 20,000 acute infections annually from 2015-2019. The shift to universal vaccination removes barriers inherent in risk assessment, eliminates the need for patients to disclose sensitive behaviors like injection drug use or multiple sexual partners, and simplifies clinical decision-making by making hepatitis B vaccination a routine component of adult preventive care.
Special populations receive particular attention in the 2025 adult vaccination guidelines. Healthcare workers and public safety personnel with potential occupational blood or body fluid exposure should be vaccinated as mandated by OSHA regulations since 1991, though actual coverage remains suboptimal at 63.4% for the complete series. Patients on hemodialysis or predialysis require higher vaccine doses (40 mcg compared to standard 20 mcg) and may need additional doses or accelerated schedules to achieve protective antibody responses, as uremia impairs immune function and vaccine effectiveness. Pregnant women may receive any of several hepatitis B vaccines including Engerix-B, Heplisav-B, Recombivax HB, or Twinrix, with overwhelming evidence of safety in pregnancy and the benefit of protecting both mother and infant.
Vaccine Products and Administration in the US 2025
| Vaccine Product | Manufacturer | Licensed Age | Dosing Schedule | Formulation |
|---|---|---|---|---|
| Engerix-B | GlaxoSmithKline (GSK) | Birth and older | 3 doses (0, 1-2, 6 months) | 10 mcg (pediatric); 20 mcg (adult) |
| Recombivax HB | Merck | Birth and older | 3 doses (0, 1-2, 6 months) | 5 mcg (pediatric); 10 mcg (adult) |
| Heplisav-B | Dynavax | 18 years and older | 2 doses (0, 1 month) | 20 mcg with CpG 1018 adjuvant |
| PreHevbrio | VBI Vaccines | 18 years and older | 3 doses (0, 1, 6 months) | Recalled November 2024 |
| Pediarix | GSK | 6 weeks – 6 years | 3 doses (combination) | Contains HepB + DTaP + IPV |
| Vaxelis | Multiple | 6 weeks – 4 years | 3 doses (combination) | Contains HepB + DTaP + IPV + Hib |
| Twinrix | GSK | 18 years and older | 3 doses (0, 1, 6 months) | Contains HepB + HepA |
*Data Source: CDC Hepatitis B Vaccine Administration Guidelines September 2025;
Hepatitis B vaccination in the United States in 2025 is supported by a diverse range of licensed products designed for different age groups and clinical needs. Traditional three-dose vaccines such as Engerix-B and Recombivax HB remain widely used for infants, children, and adults, providing reliable long-term immunity through established dosing schedules. Newer options like Heplisav-B, approved for adults 18 and older, offer a simplified two-dose, one-month schedule that significantly improves vaccination completion rates. Combination vaccines—including Pediarix and Vaxelis for young children—help streamline immunization visits by integrating Hepatitis B protection with DTaP, IPV, and Hib components. Although PreHevbrio had been an adult option, it was recalled in November 2024 and is no longer in use.
For adults requiring broader protection, Twinrix provides immunity against both Hepatitis A and Hepatitis B and follows a three-dose schedule that fits standard clinical protocols. Across all products, the availability of multiple formulations and dosing strategies allows healthcare providers to tailor vaccination plans based on age, risk factors, and the likelihood of series completion. In 2025, these vaccines form a critical part of national hepatitis prevention efforts, ensuring consistent protection for newborns, high-risk adults, and the general population while supporting public health goals to reduce Hepatitis B transmission nationwide.
Disclaimer: This research report is compiled from publicly available sources. While reasonable efforts have been made to ensure accuracy, no representation or warranty, express or implied, is given as to the completeness or reliability of the information. We accept no liability for any errors, omissions, losses, or damages of any kind arising from the use of this report.

