The European Medicines Agency’s (EMA’s) human medicines committee has recommended approval of afor adults.
The agency’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for PreHevbri on Feb. 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 Food and Drug Administration on Nov. 30, 2021. The vaccine is produced by VBI Vaccines (Delaware) Inc., based in Cambridge, Mass.
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. A 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 25-34 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 hepatitis B vaccine composed of three surface antigens of the hepatitis B virus. The vaccine is administered via injection in three doses on a 0-, 1-, and 6-month schedule and is indicated for use in adults aged 18 years and older.
The CHMP recommendation was based on data from a, which included 1,607 participants aged 18 and older, and a , which included 2,838 adults aged 18-45, according the VBI vaccine press release.
The recommendation will now be reviewed by the European Commission. If approved, PreHevbri will be the only three-antigen HBV vaccine for adults approved in the European Union.
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