MONDAY, SEPTEMBER 26, 2016

Novartis announces age indication expansion for meningococcal vaccine

Novartis, a Basel, Switzerland-based healthcare solutions company, announced on Thursday that the U.S. Food and Drug Administration approved the company's quadrivalent meningococcal vaccine for children as young as two months of age.

With the expanded indication, U.S. pediatricians can now offer Menveo oligosaccharide diphtheria CRM197 conjugate vaccine to protect infants against four of the five most common meningococcal serogroups that cause meningococcal disease.

"Each year, more children in the U.S. die or are left with permanent disability from meningococcal disease than from two other diseases combined that we routinely vaccinate infants against - rotavirus and varicella," Steve Black, a doctor with the Center for Global Health at the University of Cincinnati Children's Hospital, said. "With the expanded indication for this MCV4 vaccine, we now have the opportunity to help protect our infants against four strains of meningococcal disease earlier, when they are most vulnerable."

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

The FDA based its approval on data from three randomized multicenter studies involving more than 8,700 infants that demonstrated Menveo generated a robust protective immune response and demonstrated a safety profile when co-administered with routine pediatric vaccines.

"Despite recommendations for routine immunization of adolescents, college students living in dormitories and certain infants in the U.S., meningococcal disease continues to kill and maim," Andrin Oswald, the head of Novartis Vaccines and Diagnostics, said. "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 U.S."