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European approval for GSK’s meningitis vaccine Nimenrix

First vaccine of its kind to be approved that offers protection to young infants

GlaxoSmithKline GSK

The European Commission (EC) has approved GlaxoSmithKlines (GSK) Nimenrix, making it the first meningitis vaccine of its kind available in Europe for children as young as 12 months.

Given in one dose and well tolerated in clinical trials, the vaccine is intended to offer immunisations against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y. Together these form one of the most highly contagious strains of meningitis.

The approval puts Nimenrix in a strong position against established vaccines like Novartis' Menveo, which is only approved for persons aged 11 years and above in Europe and Sanofi Pasteur's Menactra. Sanofi's vaccine does offer protection against Neisseria meningitidis serogroups A, C, W-135 and Y and is approved for infants as young as nine months in the US, but it is currently unavailable in Europe.

Thomas Breuer, senior VP and head of global vaccine development at GSK, said: “GSK is pleased to have received approval in Europe for Nimenrix and looks forward to making this vaccine available to help protect individuals against what can be a life threatening disease.”

The form of meningitis it protects against has the potent to cause deafness, epilepsy and other neurological disordere, and it its most serious incidents can results in death.

According to GSK, those at the highest risk of contracting the disease are infants and toddlers in the first 4 years of their lives, with a second peak in adolescents.

The World Health Organization (WHO) said it is the one strain of meningitis that has the potential to cause large epidemics, with bacteria carried in the throat and able to overwhelm the body's defences allowing infection to spread to the brain.

The bacteria is transmitted between individuals through close and prolonged contract, such as coughing on someone or living in close quarters

2nd May 2012

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