FDA Approves Three-Antigen Hepatitis B Vaccine

The FDA approved a new hepatitis B vaccine [recombinant]) (PreHevbrio) for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults 18 years of age and older: small (S), middle (pre-S2), and large (pre-S1) hepatitis B surface antigens. It is the only three-antigen hepatitis B vaccine to be approved in the United States. PreHevbrio is a product of VBI Vaccines.

The FDA’s approval was based on data from two phase 3 studies that compared the safety and immunogenicity of the vaccine candidate to Engerix-B, a single-antigen HBV vaccine, in adults 18 years of age and older. PreHevbrio was shown to be noninferior, with a seroprotection rate (SPR) of 91.4% versus 76.5% for Engerix-B. Among study subjects 45 years of age and over, SPR was 89.4% with PreHevbrio, versus 73.1% with Engerix-B. In the second trial, PreHevbrio demonstrated noninferiority, with an SPR of 99.3% after the three-dose series, compared with 94.8% for Engerix-B.

The most common local reactions reported in the trials were injection-site pain and tenderness; systemic reactions included headache, fatigue, and myalgia. Consult product labeling for full prescribing information.