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EC approves Novartis' meningitis vaccine

The EC has granted Novartis a Marketing Authorisation for its meningococcal disease vaccine, Menveo, in all 27 European member states

The European Commission (EC) has granted Novartis a Marketing Authorisation for its meningococcal disease vaccine, Menveo, in all 27 European member states. 

Menveo is indicated for the immunisation of adolescents over the age of 11 and adults who are at risk of exposure to Neisseria meningitis groups A, C, W135 and Y.

Meningococcal disease is a major cause of bacterial meningitis and sepsis. It progresses rapidly and can lead to death within 24 to 48 hours of the first symptoms. Up to one in five survivors suffer life-long complications such as brain damage, learning disabilities, hearing loss and limb loss.

"Marketing approval for Menveo for people ages 11 and older is the culmination of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect against meningococcal disease," said Andrin Oswald, division head of Novartis Vaccines and Diagnostics. "Our priority is to advance the fight against meningitis through innovative vaccines that help save lives."

To support its case for Menveo to be made available for use in other age groups, the Basel-based company plans to submit additional data to the European Medicines Agency (EMA).

The US Food and Drug Administration (FDA) recently approved Menveo for use in 11-55 year olds. It has been administered to over 18,500 people worldwide and is currently being tested in multiple phase III studies in infants and toddlers.

The World Health Organisation (WHO) recommends the use of meningococcal vaccinations for all people considered to be at an increased risk of developing meningococcal disease such as adolescents, travellers to areas known for outbreaks, military personnel and Muslim pilgrims travelling to the Hajj or Umrah.

18th March 2010

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