Therapy Areas: Vaccines
VBI Vaccines Announces UK MHRA Marketing Authorisation for PreHevbri, a 3-Antigen Adult Hepatitis B Vaccine
2 June 2022 - - UK Medicines and Healthcare Products Regulatory Agency 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 in adults, US-based biopharmaceutical company VBI Vaccines Inc. (NASDAQ: VBIV) said.

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 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.

Hepatitis B is one of the world's most significant infectious disease threats with more than 290 m 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.

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, and Sci-B-Vac (Israel).

VBI Vaccines Inc. is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.

Through its approach to virus-like particles, including a proprietary enveloped VLP 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, as well as aggressive cancers including glioblastoma.

VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.