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- VBI Vaccines (NASDAQ:VBIV) is trading ~9.2% higher on above-average volume in the premarket after the company announced the FDA approval of PreHevbrio [Hepatitis B Vaccine (Recombinant)] to prevent Hep B infection in adults aged 18 years and older.
- The approval was based on two late-stage clinical trials in which PreHevbrio was compared against Engerix-B, GlaxoSmithKline’s (NYSE:GSK) single-antigen HBV shot. PreHevbrio is the first three-antigen Hep B vaccine available for U.S. adults, according to the company.
- VBI Vaccines (VBIV) plans to launch the product in the U.S. in Q1 2022. PreHevbrio is currently undergoing the review of the European Medicines Agency (EMA). In 2022, the company intends to complete regulatory submission for the vaccine in the U.K. and Canada.
Read more on late-stage data for the vaccine as generated from one of the pivotal trials.