The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Novartis‘ vaccine for a range of meningococcal group B infections.
Bexsero, indicated for individuals over two months of age against invasive meningococcal disease, is the first vaccine to provide protection to individuals of all age groups.
The committee recommends a marketing authorisation for Bexsero against meningococcal diseases caused by Neisseria meningitidis group B.
At present no authorised vaccine is available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B.
Novartis vaccines and diagnostics division head Andrin Oswald said Bexsero represents a major advance in the field of vaccine development against a very challenging disease target.
"For over two decades, our researchers and clinicians have been dedicated to finding a solution to prevent MenB disease," Oswald added.
"Our steadfast determination has been inspired by the testimonies from survivors and families who have lost loved ones to this disease."
The CHMP’s positive opinion will now be sent to the European Commission for final approval, which will be valid in all EU and European Economic Area (EEA) countries.
A comprehensive clinical programme that includes large Phase II/III clinical trials engaging almost 8,000 infants, children, adolescents and adults, has demonstrated the tolerability profile and immunogenicity of Bexsero.
Immunisation schedule options offered by Bexsero fit with routine vaccination visits, according to the company.
Image: Photomicrograph of N. meningitidis. Photo courtesy of CDC / Dr. Brodsky.