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EMA says GSK’s meningitis vaccine Nimenrix should be available in Europe

Positive opinion for use of vaccine in infants as young as 12 months

European Medicines Agency (EMA) advisors have recommended approval for GlaxoSmithKline's (GSK) Nimenrix, a new vaccine for a highly contagious strain of meningitis.

GSK had submitted the vaccine for use to protect against disease caused by Neisseria meningitidis group A, C, W-135 and Y in individuals over the age of 12 months,

The EMA's Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for the vaccine based on safety and efficacy data from trials involving more than 8,000 patients across 17 countries, which usually translates into full European approval within three months.

The vaccine is designed to protect against Neisseria meningitidis, a highly contagious disease that can lead to disability and death.

According the World Health Organization (WHO), 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.

It is estimated that between 10 per cent and 20 per cent of the world's population carries Neisseria meningitidis in their throat at any given time.

Current vaccine options include GSK's own Mencevax, as well as Novartis' Menveo and Sanofi Pasteur's Menactra.

Menveo is currently only approved for persons aged 11 years and above in Europe, however, giving GSK's Nimenrix a distinct advantage in its ability to be used in a younger population if approved.

Nimenrix would also not face competition from Menactra, which approved for infants as young as nine months in the US but is currently unavailable in Europe.

Thomas Breuer, head of global vaccine development at GSK, said: “This positive opinion represents a major milestone in our development programme and we look forward to receiving the final decision from the EMA in the coming months."

20th February 2012

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