BASEL, Switzerland — Novartis announced March 18 that the European Commission granted a marketing authorization for its vaccines against meningococcal disease.
Menveo is indicated for immunization of adolescents 11 years and older and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y.
It is the first conjugate vaccine commercially available in Europe that helps protect against four major groups of meningococcal disease. Novartis intends to submit additional data to the European Medicines Agency to support the use of Menveo in other age groups.
Meningococcal infection is a leading cause of bacterial meningitis — an infection of the membrane around the brain and spinal cord — and sepsis, a bloodstream infection. Meningococcal disease can lead to death within 24 to 48 hours of the first symptoms. Of those who survive, as many as one in five will suffer life-long complications such as brain damage, learning disabilities, hearing loss and limb loss.
"Marketing approval for Menveo for people ages 11 and older is the culmination of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect against meningococcal disease," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics. "Our priority is to advance the fight against meningitis through innovative vaccines that help save lives.”
Menveo has been administered to more than 18,500 people and is in multiple Phase III clinical studies in infants and toddlers worldwide. The U.S. Food and Drug Administration recently approved Menveo for use in people ages 11 to 55.