Updated on 19 November 2012
Singapore: The European Medicines Agency (EMA) has adopted a positive opinion for Novartis' Bexsero (meningococcal group B vaccine) for use in individuals from two months of age and older. Upon regulatory approval, Bexsero will be the first licensed broad coverage vaccine that can help protect all age groups against MenB disease, including infants, the age group at the greatest risk of infection.
"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," said Dr Andrin Oswald, division head, Novartis Vaccines and Diagnostics. "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."
Currently available vaccines do not offer broad protection against MenB, which accounts for up to 90 percent of all meningococcal disease cases in some European countries. MenB disease is easily misdiagnosed, can kill within 24 hours and may cause serious, life-long disabilities. About one-in-10 of those who contract the disease die despite appropriate treatment. Up to one-in-five survivors suffers from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss.The highest rates of MenB disease occur in the first year of life, peaking when the individual is seven months of age.
"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," said Dr Matthew Snape, consultant, pediatrics and vaccinology, Oxford vaccine group, University of Oxford. "A vaccine that is able to reduce the incidence of this disease would be a major advance towards the prevention of childhood meningitis."