EMA Recommends PreHevbri Hepatitis B Vaccine for Approval

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 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 safety and immunogenicity study, which included 1607 participants aged 18 and older, and a lot-to-lot study, which included 2838 adults aged 18 to 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.

https://www.medscape.com/viewarticle/969417?src=soc_fb_220304_mscpedt_news_mdscp_hepb&faf=1

Créditos: Comité científico Covid