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news.The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to VBI Vaccines’ PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)].
Hepatitis B virus infection is the leading cause of liver disease. Credit: Nephron / commons.wikimedia.org.
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PreHevbri is said to be the only approved 3-antigen hepatitis B vaccine for adults in the UK. It comprises the three hepatitis B surface antigens, S, pre-S1, and pre-S2, of the hepatitis B virus (HBV).
The hepatitis B vaccine has been authorised for active immunisation against infection caused by all known subtypes of HBV in adults.
It is also approved for use in the US, the UK, Israel, and the European Union/European Economic Area.
The vaccine’s brand names include PreHevbrio in the US, PreHevbri in EU/EEA and the UK, and Sci-B-Vac in Israel.
The latest regulatory approval follows the receipt of centralised marketing authorisation from the European Commission (EC) in April this year.
VBI president and CEO Jeff Baxter said: “We are pleased to announce this latest regulatory approval of PreHevbri, our third in the span of six months, and another significant milestone in our efforts to broaden access to our differentiated 3-antigen vaccine.
“Based upon the safety and immunogenicity profiles observed in the PROTECT and CONSTANT pivotal Phase 3 studies, data from which built the foundation of our FDA, EMA, and now UK MHRA approvals, we continue to believe PreHevbri will be a meaningful new intervention in the fight against hepatitis B.”
Through the immunisation with PreHevbri, hepatitis D (caused by the delta agent) is also expected to be prevented, as it does not occur in the absence of hepatitis B infection.
Furthermore, PreHevbri is expected to be available in the UK in early 2023.
