HEPLISAV-B®

[Hepatitis B Vaccine (Recombinant) Adjuvanted]

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.1

NEW ACIP VOTE FOR HEPATITIS B VACCINATION

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice (ACIP) has voted yes on the recommendation that all adults ages 19-59 receive the hepatitis B vaccine.2,*

FEBRUARY 21, 2018, ACIP UNANIMOUSLY RECOMMENDS HEPLISAV-B

The ACIP has unanimously recommended HEPLISAV-B for protecting against hepatitis B.3

*The ACIP also voted to recommend that all adults over 60 years of age with risk factors for hepatitis B infection should be vaccinated. Adults over 60 without known risk factors may receive a hepatitis B vaccination.

Hepatitis B is a vaccine-preventable liver infection caused by the hepatitis B virus (HBV).4,5

  • HBV is up to 100 times more infectious than HIV, and transmission is on the rise.
  • HBV can survive outside the body for at least 7 days. During that time, the virus is still capable of causing infection.
  • HBV can be a short-term (acute) or a long-term (chronic) illness:
    • Acute HBV occurs within 6 months after a person is exposed to HBV. In some people, acute HBV can lead to chronic HBV.
    • Chronic HBV is a lifelong disease. Without treatment, chronic HBV can cause liver cancer or liver damage that leads to liver failure.

There is no cure for hepatitis B, but effective vaccination can prevent the disease.

HEPLISAV-B is approved by the FDA and EC. Dynavax wholly owns, manufactures and holds worldwide commercial rights to HEPLISAV-B. Bavarian Nordic markets and distributes HEPLISAV B in Germany with an expected launch mid-2022.

Learn More About Hepatitis B

IMPORTANT SAFETY INFORMATION

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., 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%).


Reference:

  1. HEPLISAV-B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2020.
  2. Landmark vote by CDC’s Advisory Committee on Immunization Practices (ACIP) to recommend universal hepatitis B vaccination. Hepatitis B Foundation. November 4, 2021. Accessed November 8, 2021. https://hepb.org/news-and-events/news-2/the-cdcs-advisory-committee-on-immunization-practices-acip-voted-to-recommend-universal-hepatitis-b-vaccination/
  3. Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant. MMWR Morb Mortal Wkly Rep. 2018;67(15):455-458.
  4. https://www.cdc.gov/hepatitis/hbv/index.htm
  5. https://www.who.int/news-room/questions-and-answers/item/hepatitis-b-how-can-i-protect-myself