EMA recommends Novartis' meningitis B vaccine for approval

Hannah Blake

pharmaphorum

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended Novartis’ meningitis B vaccine, Bexsero, for approval for use in patients aged 2 months or older.

The European Commission usually follows the committee’s recommendations within three months. If approved, Novartis’ Bexsero is approved it will be the first inoculation against the meningococcus B bacterium, which is the biggest cause of meningitis in industrialised countries. Bacterial meningitis causes approximately 170,000 deaths worldwide each year, according to the WHO.

"MenB disease is a major cause of meningitis and septicemia in children, and its ability to cause a rapidly progressive, devastating illness makes it one of the infections most feared by both parents and pediatricians. A vaccine that is able to reduce the incidence of this disease would be a major advance towards the prevention of childhood meningitis."

Dr Matthew Snape, Consultant in Pediatrics and Vaccinology at the Oxford Vaccine Group, University of Oxford.

"We are proud of the major advance that Bexsero represents within the field of vaccine development against what up until now has been a very challenging disease target. For over two decades, our researchers and clinicians have been dedicated to finding a solution to prevent MenB disease. Our steadfast determination has been inspired by the testimonies from survivors and families who have lost loved ones to this disease."

Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics.

This recommendation for approval gives Novartis the chance to redeem themselves following a tough few weeks in the vaccines and pharmaceuticals space. Back in October, Italy’s health ministry banned the sale of four Novartis flu vaccines citing possible side-effects, while just last week, NICE withdrew their recommendation of Novartis’ asthma drug, Xolair, stating it was no longer cost-effective.

However, Novartis has remained positive and released a statement last week saying it believes it will produce 14 or more blockbuster drugs in the next five years.

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