Two-Dose Hep B Vaccine Approved by CDC

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of including HEPLISAV-B on its recommended products list for use to vaccinate adults against hepatitis B.

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 was approved by the U.S. Food and Drug Administration (FDA) in November 2017 for the prevention of infection caused by all known subtypes of hepatitis B virus, in adults age 18 years and older.

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.

Hepatitis B is a major public health issue in the United States, where an estimated 20,000 new infections occur each year, and approximately 850,000 people are currently living with this chronic disease.

The best way to prevent Hepatitis B is by getting the Hepatitis B vaccine, says the CDC.

The Hepatitis B vaccine is safe and effective and is usually given as 3-4 shots over a 6-month period. The Hepatitis B vaccine series is a sequence of shots that stimulate a person’s natural immune system to protect against HBV.

After the vaccine is given, the body makes antibodies that protect a person against the virus. An antibody is a substance found in the blood that is produced in response to a virus invading the body. These antibodies are then stored in the body and will fight off the infection if a person is exposed to the Hepatitis B virus in the future.

“This ACIP recommendation emphasizes the important role of HEPLISAV-B in the prevention of hepatitis B infection in adults,” said Eddie Gray, chief executive officer of Dynavax. 

“This reinforces our belief that our unique two-dose vaccine with demonstrated higher rates of protection versus ENGERIX-B, and a safety profile similar to three-dose vaccines, will become the new standard of care for adults,” said Gray.

Dynavax commercially launched HEPLISAV-B in the United States in January 2018.

HEPLISAV-B is not recommended for individuals with a history of severe allergic reaction (anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

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

For full prescribing Information for HEPLISAV-B, click here.

Dynavax's website is at www.dynavax.com.