Novartis submits meningococcal vaccine Bexsero for European approval

pharmafile | December 23, 2010 | News story | Sales and Marketing Bexsero, MenB, Novartis, Vaccine, bacterial meningitis, bloodstream infection sepsis, meningococcal disease, meningococcal vaccine 

Novartis has submitted its meningococcal vaccine Bexsero to European regulators for marketing approval.

If approved the drug will be the world’s first broad-coverage vaccine for the serogroup B strain of the disease (MenB), which accounts for up to 80% of meningococcal cases in Europe.

Meningococcal disease is a leading cause of bacterial meningitis and bloodstream infection sepsis, and vaccines are available for meningococcal disease caused by serogroups A, C, W135 and Y.

The sudden, aggressive illness can lead to death within 48 hours, with infants at the highest risk for infection by MenB.

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Bexsero (multi-component meningococcal B vaccine) contains four antigen components and Novartis predicts that most MenB strains would be covered by more than one of the antigens, preventing disease caused both by current strains and by genetic strain shifts.

In fact preliminary data shows Bexsero may cover 77% of more than 800 genetically diverse disease-causing MenB strains isolated in Europe. More analysis is expected to be available next year.

“The Bexsero submission in the EU is an important milestone toward achieving the world’s first broad-coverage MenB vaccine through our unique multi-component approach,” says Andrin Oswald, head of Novartis vaccines and diagnostics division.

“Proactive vaccination of individuals has been shown to offer the best protection against fatal infectious diseases,” Oswald concluded.

Clinical trials involved more than 7,500 infants, adolescents and adults and Novartis predicts Bexsero could protect infants vaccinated at 2, 4, 6 and 12 months of age.

Global incidence of MenB infection is estimated to be between 20,000 and 80,000 cases per year, with a 10% fatality rate. It has caused outbreaks of disease in countries such as the UK, France and New Zealand.

The vaccine was developed using so-called ‘reverse vaccinology’, decoding the genome sequence of MenB and selecting proteins most likely to be broadly-effective vaccine candidates.

Adam Hill

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