FDA Advisors Schedule Meeting to Review Hepatitis B Vaccine

Final approval decision set for December

The FDA’s Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the biologics license application for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted], Dynavax Technologies Corporation) at a meeting scheduled for November 16. Heplisav-B is a vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults (18 years of age and older). The vaccine is currently under FDA review, with a Prescription Drug User Fee Act (PDUFA) action date of December 15, 2016.

The VRBPAC reviews and evaluates data regarding the safety, efficacy, and appropriate use of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases.

Heplisav-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. The vaccine is administered in two doses over one month.

In phase 3 trials, Heplisav-B demonstrated greater and earlier protection with fewer doses compared with a currently licensed hepatitis B vaccine. It also demonstrated a safety profile similar to that of the existing vaccine.

The safety profile of Heplisav-B is based on clinical trials that generated safety data from more than 14,000 participants. The most common local reaction was injection-site pain. The most common systemic reactions included fatigue, headache, and malaise, all of which were similar to that of an existing vaccine.

Hepatitis B virus infection of the liver can lead to cirrhosis, hepatocellular carcinoma, and death. In the United States, the Centers for Disease Control and Prevention estimates that approximately 20,000 hepatitis B infections occur annually, with the majority occurring in adults. There is no cure for hepatitis B, and disease prevention through effective vaccination is critical to reducing the spread of the disease. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. The results from a Vaccine Safety Datalink study showed that 54% of adults completed the currently available three-dose hepatitis B vaccine series in one year. Those who do not complete the series may not be adequately protected against hepatitis B.

Source: Dynavax Technologies; August 6, 2016.