The US Food and Drug Administration (FDA) has expanded the indication for the quadrivalent meningococcal vaccine (Menveo, Novartis Pharmaceuticals, Inc) to infants and toddlers from age 2 months, the company announced today.
The vaccine protects against invasive disease caused by common Neisseria meningitidis serogroups A, C, Y, and W-135.
As previously reported by Medscape Medical News, Menveo has been available for use in adolescents and adults (11 - 55 years of age) since February 2010 and in children (2 - 10 years of age) since January 2011.
"With this expanded indication, pediatricians in the US can now offer a single vaccine for the protection of infants, children and adolescents against 4 of the 5 most common serogroups that cause meningococcal disease," Novartis said in a statement.
A Deadly Disease
"Each year, more children in the US die or are left with permanent disability from meningococcal disease than from 2 other diseases combined that we routinely vaccinate infants against — rotavirus and varicella," Steve Black, MD, from the Center for Global Health at University of Cincinnati Children's Hospital in Ohio, commented in the statement.
With the expanded indication, "we now have the opportunity to help protect our infants against 4 strains of meningococcal disease earlier, when they are most vulnerable," he said.
Studies show that infants younger than 7 months are the age group most vulnerable to meningococcal disease in the United States. In their first year of life, infants are more than 7 times more likely to contract the disease than 14- to 24-year-olds. Of the infants who contract the disease, more than 10% will die from it, and of those who do survive, roughly 1 in 5 will suffer permanent adverse effects.
The FDA's decision to expand use of the vaccine to infants from 2 months of age was based on data from 3 randomized studies involving more than 8700 infants, conducted in Australia, Canada, Latin America, Taiwan, and the United States.
The studies demonstrated that the quadrivalent meningococcal vaccine generated a "robust protective immune response and was generally well tolerated when administered with other routine pediatric vaccines," Novartis said.
Menveo is currently registered in more than 50 countries for active immunization to prevent invasive meningococcal disease caused by N meningitidis serogroups A, C, W-135, and Y. (In the United States, no vaccine is approved to protect against meningitis serogroup B infection.)
"Despite recommendations for routine immunization of adolescents, college students living in dormitories and certain infants in the US, meningococcal disease continues to kill and maim," said Andrin Oswald, MD, head of Novartis Vaccines and Diagnostics. "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."
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Cite this: FDA OKs Use of Meningitis Vaccine in Infants, Toddlers - Medscape - Aug 02, 2013.