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 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%). 

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

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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. 

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