European Commission marketing authorisation for PreHevbri, a 3-antigen adult hepatitis B vaccine.
VBI Vaccines Inc. announced that the European Commission (EC) has granted Marketing Authorisation for PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.
It can also be expected that hepatitis D will be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations. PreHevbri contains the full antigenic composition of the hepatitis B virus surface antigen, including the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the European Union (EU) and in the European Economic Area (EEA) countries – Iceland, Liechtenstein, and Norway.
The European Commission’s centralized marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway). VBI expects to make PreHevbri available in certain Europe an countries beginning at the end of 2022.
Related news and insights
Roche announced that the European Commission (EC) has granted approval of Polivy (polatuzumab vedotin) in combination with MabThera(rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
NICE- National Institute for Health and Care Excellence (UK) Guidance:1.1 Romosozumab (Evenity)from UCB + Amgen, is recommended as an option for treating severe osteoporosis in people after menopause who are at high risk of fracture, only if: they have had a major osteoporotic fracture (spine, hip, forearm or humerus fracture) within 24 months (so are at imminent risk of another fracture) and the company provides romosozumab according to the commercial arrangement.