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 European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion for VBI’s 3-antigen hepatitis B (HBV) vaccine, under the brand name PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)].
The CHMP recommends PreHevbri for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.
“The positive CHMP opinion for PreHevbri underscores its potential to be a meaningful option for healthcare providers as they help protect their patients against hepatitis B,” said Jeff Baxter, VBI Vaccines President & CEO. “Hepatitis B remains a persistent public health problem in Europe and this milestone is a meaningful advancement in our efforts to be part of the solution.”
The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) 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 (EEA) countries – Iceland, Liechtenstein, and Norway. In the United Kingdom (UK), the MAA for VBI’s 3-antigen HBV vaccine is expected to be reviewed as part of the EC Decision Reliance Procedure (ECDRP), 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.
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.
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® (Israel).
U.S. Indication and Use
PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.
U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.
Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please see Full Prescribing Information.