Friday, November 16, 2012

First ever broad coverage MenB vaccine for all age groups Bexasero receives EU CHMP positive recommendation

Novartis has received positive CHMP opinion for Bexsero. Bexasero  if approved would be the first first and only broad coverage MenB vaccine to help protect all age groups, including infants, who are at greatest risk of infection.Bexasero covers an estimated 70 to 90% of circulating MenB strains in key European countries.  Since Meningococcal B (“MenB”) is a devastating disease: it can kill previously healthy individuals within 24 hours, and leaves 1 in 5 of those who survive it with life-long disabilities, we expect the vaccine to be included in the immunization program for all ages and can generate blockbuster sales.
Currently available vaccines do not offer broad protection against MenB, which accounts for up to 90% of all meningococcal disease cases in some European countries.

The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union (EU) and European Economic Area (EEA) countries. Upon approval, each member state will evaluate Bexsero reimbursement schemes and determine the potential inclusion of the vaccine into National Immunization Programs.

Starting from two months of age, Bexsero offers several immunization schedule options that can fit with routine vaccination visits.  Estimated coverage of 70 to 90% of circulating MenB strains in key European countries

A phase 3 study for Bexasero in the US is still to begin. 



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