U.S. Food and Drug Administration (FDA) has approved Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults. Hepatitis B is an extremely infectious and potentially deadly virus.
There is no cure for hepatitis B, and infections are on the rise. Hepatitis B can be prevented through effective vaccination. Current hepatitis B vaccines require three shots over a six-month period, however, almost half of adults fail to complete the series within one year.
Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B.
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease. In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.
The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas. People with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes.
Heplisav-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to Heplisav-B. Heplisav-B is indicated for active immunization against infection caused by all known subtypes of hepatitis B virus. Heplisav-B is approved for use in adults 18 years of age and older.
Do not administer Heplisav-B to individuals with a history of severe allergic reaction like 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, fatigue and headache.
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