FDA clears first new hep B vaccine in 25 years

The US Food and Drug Administration is allowing onto the market the first new hepatitis B vaccine in more than 25 years with the approval of Dynavax’ Heplisav-B.

The vaccine is the only one to offer a two-dose regimen for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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, the firm notes.

Hepatitis B is a potentially deadly virus 50 to 100 times more infectious than HIV. Infections are on the rise and there is no cure, but the disease can be prevented through effective vaccination.

Heplisav-B’s approval was based on data from three Phase III trials demonstrating that it delivered higher rates of protection compared to Engerix-B, according to Dynavax.

On the safety side, the most common local reaction was injection site pain (23 percent for Heplisav to 39 for Engerix-B), while the most common systemic reactions were fatigue (11 percent to 17 percent, respectively) and headache (8 percent to 17 percent).

"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," said William Schaffner, professor of Preventive Medicine, Vanderbilt University Medical Center.

"Too many at-risk adults remain unprotected against this virus. 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 as a public health problem in the United States."

The vaccine was rejected by the FDA in November last year, with a request for more information relating to several areas, including clarification on specific adverse events of special interest, a numerical imbalance in a small number of cardiac events in a single study, new analyses of the integrated safety data base across different time periods, and post-marketing commitments.