The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted in favor of Heplisav-B™ (hepatitis B vaccine [recombinant], adjuvanted; Dynavax) for use in the prevention of infection caused by all known subtypes of hepatitis B virus.

The vaccine was approved by the Food and Drug Administration (FDA) in November 2017 for use in adults 18 years of age and older. 

The FDA approval of Heplisav-B was based on data from 3 phase 3 noninferiority trials involving close to 10,000 adults who received the vaccine. Results from the largest study (n=6665) 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%). 


Continue Reading

The new ACIP recommendation will be published in the Morbidity and Mortality Weekly Report (MMWR) after CDC review and approval.

Heplisav-B is administered by intramuscular injection in 2 doses one month apart. It is supplied as a sterile solution for injection in 0.5mL single-dose vials. 

Related Articles

Reference

Dynavax’s HEPLISAV-B™ [hepatitis B vaccine (recombinant), adjuvanted] recommended by CDC Advisory Committee on Immunization Practices for the prevention of hepatitis B in adults [press release]. Berkeley, CA; Globe Newswire: February 21, 2018. Accessed February 22, 2018.

This article originally appeared on MPR