New Vaccine for Hepatitis B Gets FDA Approval

Heplisav-B is the first new hepatitis B vaccine in the U.S. in more than 25 years
Heplisav-B is the first new hepatitis B vaccine in the U.S. in more than 25 years

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

Infection with hepatitis B virus can have serious consequences including massive hepatic necrosis and chronic active hepatitis. Chronically infected patients are at risk for cirrhosis and hepatocellular carcinoma.

Heplisav-B is administered by intramuscular injection in two doses one month apart. "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," said William Schaffner, MD, professor of Preventive Medicine, Vanderbilt University Medical Center. 

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The approval of Heplisav-B was based on data from three Phase 3 non-inferiority trials involving close to 10,000 adults who received the vaccine. Results from the largest study (n=6,665) showed that compared to Engerix-B,  Heplisav-B demonstrated a statistically significantly higher rate of protection (95% vs. 81%). In a subgroup analysis of participants with type 2 diabetes (n=961), Heplisav-B provided a statistically significantly higher rate of protection compared to Engerix-B (90% vs. 65%). 

Heplisav-B is expected to be available in the first quarter of 2018. Each 0.5mL dose is formulated to contain 20mcg of HBsAg and 3000mcg of CpG 1018 adjuvant. 

For more information visit Dynavax.com.