New Vaccine Approved for All Known Subtypes of Hepatitis B Virus

The Food and Drug Administration has granted approval for the PreHevbrio™ vaccine for prevention of all known subtypes of the hepatitis B virus (HBV) in adults ages 18 and older.

The vaccine contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved hepatitis B vaccine for adults in the US to have all 3.

This approval stemmed from results of 2 phase 3 clinical studies, PROTECT and CONSTANT. In those studies, PreHevbrio was compared to Engerix-B, a single-antigen HBV vaccine. PreHevbrio elicited higher rates of seroprotection in all subjects aged 18 years and older (91.4% vs. 76.5%), including in adults aged 45 years and older (89.4% vs. 73.1%). Safety analyses from both studies demonstrated good tolerability and no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue. All adverse events generally resolved without intervention after 1-2 days.

This vaccine is expected to be available in the U.S. in the first quarter of 2022.

—Allison Casey

VBI Vaccines Announces FDA Approval of PreHevbrio™ for the Prevention of Hepatitis B in Adults. News Release. VBI Vaccines Inc; December 1, 2021.