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Demonstrated safety profile in clinical trials of more than 10,000 participants1

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Percentage of participants with local or systemic reactions within 7 days of vaccination2

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Trial 1 reactions chart: columns from left to right: 1st column is HEPLISAV-B post dose, with sub-columns for dose 1 (n=1810 for local reactions, n=1784 for fever) and 2 (n=1798 for local reactions, n=1764 for fever). 2nd column is Engerix-B post dose, with sub-columns for doses 1 (n=605 for local reactions, n=696 for fever), 2 (n=603 for local reactions, n=590 for fever), and 3 (n=598 for local reactions, n=561 for fever). Rows: Local reactions: injection site pain %: 38.5, 34.8, 33.6, 24.7, 20.2. injection-site redness %: 4.1, 2.9, 0.5, 1.0, 0.7. injection-site swelling %: 2.3, 1.5, 0.7, 0.5, 0.5. Systemic reactions: fatigue %: 17.4, 13.8, 16.7, 11.9, 10.0. headache %: 16.9, 12.8, 19.2, 12.3, 9.5. malaise %: 9.2, 7.6, 8.9, 6.5, 6.4. Fever %: 1.1, 1.5, 1.8, 1.7, 1.8.

Study 1 was a randomized, observer-blind, active-controlled, multicenter study in Canada and Germany in which 1810 subjects received at least 1 dose of HEPLISAV‑B and 605 subjects received at least 1 dose of Engerix‑B® [Hepatitis B Vaccine (Recombinant)]. Enrolled subjects had no history of hepatitis B vaccination or infection. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by saline placebo at 6 months. Engerix‑B was given at 0, 1, and 6 months. In the total study population, the mean age was 40 years; 46% of the subjects were men; 93% were white, 2% black, 3% Asian and 3% Hispanic; 26% were obese, 10% had hypertension, 8% had dyslipidemia, and 2% had diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.

Trial 2 reactions chart: columns from left to right: 1st column is HEPLISAV-B post dose, with sub-columns for dose 1 (n=1952 for local reactions, n=1923 for fever) and 2 (n=1905 for local reactions, n=1887 for fever). 2nd column is Engerix-B post dose, with sub-columns for doses 1 (n=477 for local reactions, n=472 for fever), 2 (n=464 for local reactions, n=459 for fever), and 3 (n=448 for local reactions, n=438 for fever). Rows: Local reactions: injection site pain %: 23.7, 22.8, 18.4, 15.9, 13.8. injection-site redness %: 0.9, 0.7, 0.6, 0.2, 0.2. injection-site swelling %: 0.9, 0.6, 0.6, 0.6, 0.2. Systemic reactions: fatigue %: 12.6, 10.8, 12.8, 12.1, 9.4. headache %: 11.8, 8.1, 11.9, 9.5, 8.5. malaise %: 7.7, 7.0, 8.6, 7.1, 5.1. myalgia %: 8.5, 6.4, 9.6, 8.0, 4.5. Fever %: 0.6, 0.6, 0.6, 0.9, 0.7.

Study 2 was a randomized, observer-blind, active-controlled, multicenter study in Canada and the United States in which 1968 subjects received at least 1 dose of HEPLISAV‑B and 481 subjects received at least 1 dose of Engerix‑B. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by saline placebo at 6 months. Enrolled subjects had no history of hepatitis B vaccination or infection. Engerix‑B was given at 0, 1, and 6 months. In the total population, the mean age was 54 years; 48% of subjects were men; 82% were white, 15% black, 1% Asian and 6% Hispanic; 44% were obese, 30% had hypertension, 30% had dyslipidemia, and 8% had diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.

*Redness and swelling ≥2.5 cm.

†Oral temperature ≥100.4˚F (38.0˚C).

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Percentage of participants who experienced adverse events after vaccination2

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Reported in 3 clinical trials with 12 months of follow-up

Trial 1: HEPLISAV-B (n=1810). Within 28 days of any injection. Unsolicited adverse events: 42.0%. Within 7 months of the first vaccine dose. Serious adverse events: 1.5%. Immune-mediated adverse events: 0.2%. Engerix-B (n=605). Within 28 days of any injection. Unsolicited adverse events: 41.3%. Within 7 months of the first vaccine dose. Serious adverse events: 2.1%. Immune-mediated adverse events: 0.7%. Trial 2: HEPLISAV-B (n=1968). Within 28 days of any injection. Unsolicited adverse events: 35.4%. Within 12 months of the first vaccine dose. Serious adverse events: 3.9%. Immune-mediated adverse events: 0.2%. Engerix-B (n=481). Within 28 days of any injection. Unsolicited adverse events: 36.2%. Within 12 months of the first vaccine dose. Serious adverse events: 4.8%. Immune-mediated adverse events: 0.0%. Trial 3: HEPLISAV-B (n=5587). Within 28 days of any injection. Unsolicited adverse events: 20.1%. Within 13 months of the first vaccine dose. Serious adverse events: 6.2%. Immune-mediated adverse events: 0.1%. Engerix-B (n=2781). Within 28 days of any injection. Unsolicited adverse events: 20.1%. Within 13 months of the first vaccine dose. Serious adverse events: 5.3%. Immune-mediated adverse events: 0.0%.

Study 3 was a randomized, observer-blind, active-controlled, multicenter study in the United States in which 5587 subjects received at least 1 dose of HEPLISAV‑B and 2781 subjects received at least 1 dose of Engerix‑B. Enrolled subjects had no history of hepatitis B vaccination or infection. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by saline placebo at 6 months. Engerix‑B was given at 0, 1, and 6 months. In the total study population, the mean age was 50 years; 51% were men; 71% were white, 26% black, 1% Asian, and 9% Hispanic; 48% were obese, 36% had hypertension, 32% had dyslipidemia, and 14% had type 2 diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.

‡For trial 3, only unsolicited medically attended adverse events—those for which a subject sought medical care—were captured.

§For trials 2 and 3, new-onset autoimmune adverse events are listed.

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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.2

Not all liver cancer is caused by the hepatitis B virus.3

Please see full Prescribing Information.

REFERENCES:

1. 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. 2. HEPLISAV‑B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2023. 3. 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