FDA Approves VBI Vaccines' 3-Antigen Hepatitis B Vaccine

The FDA has approved VBI Vaccines Inc's (NASDAQ: VBIV) PreHevbrio [Hepatitis B Vaccine (Recombinant)] to prevent the infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. 

• PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens and is the only approved 3-antigen HBV vaccine for adults in the U.S.
• The approval of PreHevbrio was based on the results from two Phase 3 clinical studies that compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. 
• Data showed that PreHevbrio elicited higher seroprotection rates in all subjects (91.4% vs. 76.5%). 
• The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. 
• The most common adverse events were injection site pain and tenderness, myalgia, and fatigue, which generally resolved without intervention in 1-2 days.
• VBI expects to make PreHevbrio available in the U.S. in Q1 of 2022 and has partnered with Syneos Health for the past two years.
• European Medicines Agency is currently reviewing the marketing application for VBI's 3-antigen HBV vaccine. 
• The Company expects to complete submissions to the U.K and Canadian regulatory authorities in 2022.
• See here Benzinga's Full FDA Calendar.
• Price Action: VBIV shares are up 3.29% at $3.14 during the market session on the last check Wednesday.