The European Medicines Agency's (EMA's) human medicines committee has recommended approval of a hepatitis B vaccine for adults.
The agency's Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for PreHevbri on February 24 for active immunization against hepatitis B virus (HBV) infection. PreHevbri (PreHevBrio in the United States and Sci-B-Vac in Israel) received approval from the US Food and Drug Administration on November 30, 2021. The vaccine is produced by VBI Vaccines (Delaware) Inc, based in Cambridge, Massachusetts.
The World Health Organization estimates that more than 290 million people globally are infected with HBV. HBV is the leading cause of liver disease, and an estimated 900,000 people die every year from complications from chronic HBV infection, according to a VBI Vaccine press release. A 2019 report from the European Centre for Disease Prevention and Control found that adults in the European Union aged 35–44 had the highest rates of acute infections with HBV, and people aged 25 to 34 had the highest rate of chronic HBV infections. Vaccination programs are key interventions in preventing transmission of the virus, the report noted.
PreHevbri is a hepatitisB vaccine composed of three surface antigens of the hepatitis B virus.
