The US Food and Drug Administration (FDA) has expanded age indication for Novartis' Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) to include infants and toddlers aged two months and more.
Menveo is a quadrivalent conjugate vaccine developed for the prevention of meningococcal disease caused by four strains of the bacterium Neisseria meningitidis (N. meningitidis).
Novartis vaccines and diagnostics head Andrin Oswald said despite recommendations for routine immunization of adolescents, college students living in dormitories and certain infants in the US, meningococcal disease continues to kill.
"With this approval for the expanded use of Menveo, we hope that health authorities will deploy this vaccine to further reduce the burden of this devastating disease in the US," Oswald added.
The approval was based on data from three randomized multicenter studies conducted in Australia, Canada, Latin America, Taiwan and the US involving more than 8,700 infants.
In the studies, Menveo established a protective immune response with considerable safety profile when co-administered with routine pediatric vaccines.
