On Aug. 1, 2013, Novartis announced the U.S. Food and Drug Administration (FDA) had approved Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) to help prevent meningococcal disease caused by four strains of the bacterium Neisseria meningitidis (N. meningitidis) in infants and toddlers from 2 months of age.

Infants younger than 7 months old were the most vulnerable age group to meningococcal disease in the U.S. In their first year of life, infants are about seven times more likely to contract the disease than 14 to 24 year olds.

This FDA approval was based on data from three randomized multicenter studies involving more than 8,700 infants, conducted in Australia, Canada, Latin America, Taiwan and the US. The studies demonstrated that Menveo generated a robust protective immune response and a demonstrated safety profile when co-administered with routine pediatric vaccines. In the US, there is currently no approved vaccine, including Menveo, to help protect against meningitis serogroup B infections.