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 cause liver cancer. From 2018‑2022, there were an estimated 13,000‑22,000 cases of acute hepatitis B annually; some may progress to chronic hepatitis B and potentially life-threatening consequences.1-4

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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~133 million
people are now eligible for protection from hepatitis B1,6

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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 cause liver cancer. From 2018–2022, there were an estimated 13,000–22,000 cases of acute hepatitis B annually; some may progress to chronic hepatitis B and potentially life-threatening consequences.1-4

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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.7,8

Do Your Part
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NO ONE SHOULD GET HEP‑B

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Higher and faster protection,§ demonstrated safety5,9

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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 participants9

§Compared to those who received 3 doses of Engerix‑B.5,9

*As of April 2022, 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 risk factors may receive hepatitis B vaccination. Please refer to the hepatitis B vaccination guidelines noted in the MMWR publication for the specific risk factors for hepatitis B. This recommendation applies to adults who have not received a complete hepatitis B vaccine series in their lifetime.1

‡For most people, hepatitis B clears on its own. For those who don't clear the virus, the resulting health complications can be lifelong or even deadly. There is no way of definitively knowing who will clear the virus and who will not.1,2

HBV=hepatitis B virus; HHS=Department of Health and Human Services; MMWR=Morbidity and Mortality Weekly Report; 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 clinical studies of HEPLISAV‑B in pregnant women. Available human data on HEPLISAV‑B administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

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.10

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. Last reviewed February 9, 2024. Accessed June 4, 2024. https://www.cdc.gov/hepatitis-b/hcp/clinical-overview/ 3. Centers for Disease Control and Prevention. Number of reported cases of acute hepatitis B virus infection and estimated infections — United States, 2014–2021. Last reviewed August 7, 2023. Accessed May 29, 2024. https://www.cdc.gov/hepatitis/statistics/2021surveillance/hepatitis-b/figure-2.1.htm 4. Centers for Disease Control and Prevention. Hepatitis B surveillance 2022. Last reviewed April 3, 2024. Accessed May 29, 2024. https://www.cdc.gov/hepatitis/statistics/2022surveillance/hepatitis-b.htm 5. HEPLISAV‑B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2023. 6. Data on file. Dynavax Technologies Corporation. Flow model for universal hepatitis B vaccination (version 4.5) assumptions. May 24, 2021. 7. World Health Organization. Global health sector strategy on viral hepatitis 2016–2021 towards ending viral hepatitis. June 2016. 8. U.S. Department of Health and Human Services. Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025). 2020. Washington, DC. 9. 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. 10. National Cancer Institute. Liver cancer causes, risk factors, and prevention. Last updated May 15, 2024. Accessed July 15, 2024. https://www.cancer.gov/types/liver/what-is-liver-cancer/causes-risk-factors