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On December 1, 2021, VBI Vaccines announced that the US FDA has approved the third-generation hepatitis B virus (HBV) vaccine PreHevbrio (Sci-B-Vac) to be used to prevent all known HBV in adults 18 years and older Infections caused by subtypes
Hepatitis B is one of the most important infectious disease threats in the world, with more than 290 million people infected worldwide
PreHevbrio is the third-generation hepatitis B vaccine developed by VBI Vaccines.
Image source: VBI Vaccines official website
The approval of PreHevbrio is based on the positive results of two pivotal Phase 3 clinical trials
The comprehensive safety analysis of the two trials showed that the vaccine is well tolerated and has no unanticipated reactogenicity
Reference materials:
[1] VBI Vaccines Announces FDA Approval of PreHevbrio™ for the Prevention of Hepatitis B in Adults.