By: IPP Bureau
Last updated : February 27, 2022 4:08 pm
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
VBI Vaccines announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion for VBI’s 3-antigen hepatitis B (HBV) vaccine, under the brand name PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)]. The CHMP recommends PreHevbri for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.
“The positive CHMP opinion for PreHevbri underscores its potential to be a meaningful option for healthcare providers as they help protect their patients against hepatitis B,” said Jeff Baxter, VBI’s President & CEO. “Hepatitis B remains a persistent public health problem in Europe and this milestone is a meaningful advancement in our efforts to be part of the solution.”
The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for PreHevbri in the EU is expected in the coming months. At this time, PreHevbri has not been approved for commercial use in the EU. If approved by the EC, the centralized marketing authorization would be valid in all EU Member States as well as in the European Economic Area (EEA) countries – Iceland, Liechtenstein, and Norway. In the United Kingdom (UK), the MAA for VBI’s 3-antigen HBV vaccine is expected to be reviewed as part of the EC Decision Reliance Procedure (ECDRP), the process for which is now being initiated upon receipt of positive CHMP opinion.
The CHMP’s positive opinion was supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – as well as other relevant data.