FDA approves Menveo for use in infants and toddlers from 2 months of age

Novartis said that the US Food and Drug Administration (FDA) approved its Menveo for use in infants and toddlers from 2 months of age. Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) helps prevent meningococcal disease caused by four strains of the bacterium Neisseria meningitidis (N. meningitidis). Novartis said that with this expanded indication, “pediatricians in the US can now offer a single vaccine to help protect infants, children and adolescents against four of the five most common serogroups that cause meningococcal disease.” 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 vaccines1.”