Study boosts Novartis vax's bid for infant OK
What's the best way to boost sales of a key vaccine? Get it approved for infants, of course. And Novartis is one step closer to doing just that with Menveo, its meningococcal shot. Now approved for the 11-to-55 crowd, Menveo is under review for 2- to 10-year-olds at the FDA and European Medicines Agency, and Novartis plans to submit some promising new data for approval in infants from two months to 2 years.
A new trial of 4,500 babies found that four doses generated strong immune response against four strains of the bacteria. One month after the last dose--given at 12 months of age--the infants' immune response ranged from 94 percent to 100 percent, depending on the serotype. Perhaps as important was that it was well tolerated even when administered alongside the usual child vaccines.
"[I]nfants should be directly protected from this unpredictable and devastating disease," Novartis vaccine chief Andrin Oswald says in a statement. "These data are another step in the significant progress Novartis is making toward our goal of protecting all age groups."
Menveo's direct rival--the Sanofi Pasteur shot Menactra--is approved for ages 2 to 10 years. So, if Novartis can pull off an infant approval, it would be the only quadrivalent shot approved for that age group. The company would also have to get the Centers for Disease Control and Prevention on board; the agency only recommends meningococcal vaccination for children under 11 if they're at high risk for the disease.