FDA: New Vaccine Approved for Hepatitis B

The US Food and Drug Administration has approved Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]) for the prevention of infection caused by all hepatitis B virus (HBV) subtypes in adults age 18 years or older.

Heplisav-B is the first new vaccine for HBV in more than 25 years in the United States and is the only 2-dose HBV vaccine for adults.
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The approval was based on three Phase 3 non-inferiority trials of nearly 10,000 adult participants who were administered Heplisav-B. The results of each trial showed that Heplisav-B was associated with a significantly higher rate of protection compared with Engerix-B (95% vs 81%).

The most commonly reported local reaction across the 3 trials was injection site pain (23% to 39%), and the most commonly reported systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).

—Christina Vogt

Reference:

Dynavax announced FDA approval of HEPLISAV-B(TM) for prevention of hepatitis B in adults [press release]. Berkeley, CA. Dynavax. November 9, 2017. http://investors.dynavax.com/releasedetail.cfm?ReleaseID=1048181. Accessed November 13, 2017.