VBI Vaccines Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human use has adopted a positive opinion for VBI's 3-antigen hepatitis B vaccine, under the brand name PreHevbri™. The CHMP recommends PreHevbri for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults. The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application for PreHevbri in the EU is expected in the coming months.

At this time, PreHevbri has not been approved for commercial use in the EU. If approved by the EC, the centralized marketing authorization would be valid in all EU Member States as well as in the European Economic Area countries – Iceland, Liechtenstein, and Norway. In the United Kingdom the MAA for VBI's 3-antigen HBV vaccine is expected to be reviewed as part of the EC Decision Reliance Procedure the process for which is now being initiated upon receipt of positive CHMP opinion.

The CHMP's positive opinion was supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – as well as other relevant data. 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. VBI's hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus. It is approved for use in the United States and in Israel, and regulatory submissions are still under review in Europe and in Canada.

The brand names for this vaccine are: PreHevbrio™ (U.S.), PreHevbri™ (European Union), and Sci-B-Vac®.