3rd Generation Hepatitis Vaccine Granted UK Authorization

Massachusetts-based VBI Vaccines Inc. announced today that the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for PreHevbri™ for active immunization against infection caused by all known subtypes of hepatitis B virus (HBV) in adults.

VBI stated on June 1, 2022, that it expects to make PreHevbri available in the U.K. in early 2023.

"We are pleased to announce this latest regulatory approval of PreHevbri, our third in six months, and another significant milestone in our efforts to broaden access to our differentiated 3-antigen vaccine," commented Jeff Baxter VBI's President and CEO, in a related press release.

"Based upon the safety and immunogenicity profiles observed in the pivotal Phase 3 studies, data from which built the foundation of our U.S. FDA, EMA, and now MHRA approvals, we continue to believe PreHevbri will be a meaningful new intervention in the fight against hepatitis B."

U.K. marketing authorization follows the European Commission's centralized marketing authorization received in April 2022.

PreHevbri is a 3rd generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S, of the HBV.

Furthermore, it has demonstrated safety and efficacy in over 500,000 patients. 

Additional hepatitis vaccine news is posted at PrecisionVaccinations.com/Hepatitis.

Note: VBI's media statement was curated for mobile readers.