NO ONE SHOULD GET HEP‑B

The ACIP recommends universal vaccination of all eligible adults against hepatitis B1

Help protect your patients today against hepatitis B and its serious consequences, which may include cirrhosis and liver cancer2

Your Role Is Critical
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For most people, HBV clears on its own. But for those who don’t clear the virus, it can progress to chronic hepatitis B and potentially life-threatening consequences such as liver cancer. From 2018‑2022, there were an estimated 13,000‑22,000 cases of acute hepatitis B annually in the US.2-4

HEPLISAV‑B does not treat liver diseases such as cirrhosis or liver cancer.5

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The ACIP recommendation has significantly expanded. Now all eligible adults should be protected against hepatitis B.1*

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From risk-based to routine age-based From risk-based to routine age-based ‍
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Over 130 million
people are now eligible for protection1,7,8

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Hepatitis B can have serious consequences, including liver cancer2†

†For most people, HBV clears on its own. But for those who don’t clear the virus, it can progress to chronic hepatitis B and potentially life-threatening consequences such as liver cancer. From 2018‑2022, there were an estimated 13,000‑22,000 cases of acute hepatitis B annually in the US.2-4

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There is no cure for hepatitis B4

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Although treatments are available, the best way to prevent it is through vaccination‡

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By routinely identifying eligible adults and recommending vaccination, we can help eliminate this deadly virus. The WHO and HHS have goals to eliminate the threat of hepatitis B by 2030. Together, we can do it.9,10

Do Your Part
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NO ONE SHOULD GET HEP‑B

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Higher and faster protection,§ demonstrated safety5,11

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Faster protection with 2‑dose completion in 1 month5

Pivotal trials showed greater than 90% of participants protected across multiple patient types5

Demonstrated safety profile in clinical trials of more than 10,000 participants11

§Compared to those who received 3 doses of Engerix‑B.5,11

*The ACIP recommends hepatitis B vaccination for all adults aged 19–59 and for adults aged ≥60 years with risk factors. Adults aged ≥60 years without known risk factors may receive hepatitis B vaccination. This recommendation does not apply to adults who have received a complete HBV vaccine series in their lifetime or have a history of HBV infection.1

‡For most people, HBV clears on its own. But for those who don’t clear the virus, it can progress to chronic hepatitis B and potentially life-threatening consequences such as liver cancer. From 2018–2022, there were an estimated 13,000–22,000 cases of acute hepatitis B annually in the US.2‐4

HBV=hepatitis B virus; HHS=Department of Health and Human Services; WHO=World Health Organization

Your Role Is Critical
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ACIP Recommendation
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INDICATION AND IMPORTANT SAFETY INFORMATION + –

INDICATION
HEPLISAV‑B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV‑B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV‑B, including yeast.

IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV‑B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV‑B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV‑B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV‑B.

Hepatitis B has a long incubation period. HEPLISAV‑B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%‑39%), fatigue (11%‑17%), and headache (8%‑17%).

There are no adequate and well-controlled studies of HEPLISAV‑B in pregnant individuals. Available data, primarily in individuals who received one dose of HEPLISAV‑B in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage.

It is not known whether HEPLISAV‑B is excreted in human milk. Data are not available to assess the effects of HEPLISAV‑B on the breastfed infant or on milk production/excretion.

Vaccination with HEPLISAV‑B may not result in protection of all vaccine recipients.

ADDITIONAL IMPORTANT INFORMATION
HEPLISAV‑B does not treat liver diseases such as cirrhosis or liver cancer.5

Not all liver cancer is caused by the hepatitis B virus.12

Please see full Prescribing Information.

REFERENCES:

1. Weng MK, Doshani M, Khan MA, et al. Universal hepatitis B vaccination in adults aged 19–59 years: updated recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(13):477-483. doi:10.15585/mmwr.mm7113a1 2. Centers for Disease Control and Prevention. Clinical overview of hepatitis B. Updated February 9, 2024. Accessed January 8, 2025. https://www.cdc.gov/hepatitis-b/hcp/clinical-overview/ 3. Centers for Disease Control and Prevention. Number of reported cases and estimated infections of acute hepatitis B — United States, 2015–2022. Updated October 21, 2024. Accessed January 23, 2025. https://www.cdc.gov/hepatitis-surveillance-2022/hepatitis-b/figure-2-1.html 4. Centers for Disease Control and Prevention. Hepatitis B surveillance 2022. Updated April 4, 2024. Accessed January 28, 2025. https://www.cdc.gov/hepatitis-surveillance-2022/hepatitis-b/index.html 5. HEPLISAV‑B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2024. 6. Hall EW, Weng MK, Harris AM, et al. Assessing the cost-utility of universal hepatitis B vaccination among adults. J Infect Dis. 2022;226(6):1041-1051. doi:10.1093/infdis/jiac088 7. Data on file. Dynavax Technologies Corporation. Flow model for universal hepatitis B vaccination (version 4.5) assumptions. May 24, 2021. 8. Data on file. Dynavax Technologies Corporation. Hep B market map. Final readout. December 3, 2024. 9. World Health Organization. Global Health Sector Strategy on Viral Hepatitis 2016–2021: Towards Ending Viral Hepatitis. June 2016. 10. Nelson JC, Bittner RC, Bounds L, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a vaccine safety datalink study. Am J Public Health. 2009;99(S2):S389-S397. doi:10.2105/AJPH.2008.151332 11. Data on file. Dynavax Technologies Corporation. FDA Advisory Committee Briefing Document: HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted]. Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD. 12. National Cancer Institute. Liver cancer causes, risk factors, and prevention. Updated May 15, 2024. Accessed July 15, 2024. https://www.cancer.gov/types/liver/what-is-liver-cancer/causes-risk-factors