VBI Vaccines Announces UK MHRA Marketing Authorisation for PreHevbri, a 3-Antigen Adult Hepatitis B Vaccine

• PreHevbri is the only approved 3-antigen hepatitis B vaccine for adults in the United Kingdom
• Approval follows the European Commission’s marketing authorisation, granted in April 2022

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

UK marketing authorisation follows the European Commission’s (EC) centralized marketing authorisation received in April 2022, and was conducted as part of the EC Decision Reliance Procedure (ECDRP). VBI expects to make PreHevbri available in the UK in early 2023.

“We are pleased to announce this latest regulatory approval of PreHevbri, our third in the span of six months, and another significant milestone in our efforts to broaden access to our differentiated 3-antigen vaccine,” said Jeff Baxter, VBI’s President and CEO. “Based upon the safety and immunogenicity profiles observed in the PROTECT and CONSTANT pivotal Phase 3 studies, data from which built the foundation of our FDA, EMA, and now UK MHRA approvals, we continue to believe PreHevbri will be a meaningful new intervention in the fight against hepatitis B.”

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

About PreHevbri

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United Kingdom, the United States, and Israel.  The brand names for this vaccine are: PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel).

Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu and from the UK MHRA’s website at products.mhra.gov.uk.

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.  VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.