The European Commission has approved Novartis' Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from two months of age and older. Novartis is committed to making Bexsero available as soon as possible.

"This meningitis B vaccine is the most important medical breakthrough in the 30 years since I lost my son to the disease," said Meningitis UK founder Steve Dayman MBE. "It could save thousands of lives and prevent other parents suffering the same tragedy. The vaccine must be made widely available through the immunisation schedule as soon as possible - any delay could mean lives lost."

MenB disease is a bacterial infection and is the leading cause of meningitis across Europe, particularly in infants. Although rare, one reason this disease is so feared is that it affects healthy people rapidly and without warning. Symptoms can often resemble the flu, making this disease easily misdiagnosed in its early stages. In many cases, doctors simply cannot treat infected patients soon enough to avoid serious outcomes. About one in ten of those who contract the disease will die despite appropriate treatment. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss. Prevention through vaccination is therefore the best defense against this aggressive disease.

"Each year, thousands of parents see their children die or left with severe disabilities as a result of this devastating disease. Through the combined efforts of many people over two decades, we are closer than ever to seeing an end to this suffering," said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. "Our vision is a world without meningitis, and our priority is to work with decision makers across Europe to ensure there is broad and timely access to vaccination."

Following today's approval, EU member states will evaluate Bexsero for potential inclusion into national immunization programmes and, where relevant, reimbursement schemes. Novartis is already engaging with governments interested in the early adoption of the vaccine.

Bexsero is the result of more than 20 years of pioneering vaccine research, and its tolerability profile and immunogenicity have been established through a comprehensive clinical program involving infants, children, adolescents and adults. Starting at two months of age, Bexsero offers several immunization schedule options that could fit with routine vaccination visits.

The approval of Bexsero underscores the unique leadership position of Novartis in the global fight against devastating meningococcal disease. Together, Bexsero and Menveo help to protect against all five main serogroups of meningococcal bacteria (A, C, W-135, Y and now B) that cause the majority of cases around the world.

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. The company offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products.