FDA approves first meningococcal vaccine for infants and toddlers

May 10, 2011

FDA approved the use of meningococcal (A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) in children aged as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

FDA approved the use of meningococcal (A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) in children aged as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

More than 3,700 children as young as 9 months of age received a 2-dose series of Menactra in 4 clinical studies that evaluated the safety of the vaccine. The studies showed that the 2-dose series, given to children aged 9 months produces antibodies in the blood that are protective against the disease. The most common adverse events reported in children who received Menactra aged 9 months and 12 months were injection-site tenderness and irritability. The incidence of fever was comparable to other routinely recommended vaccines.

Menactra was originally approved on January 14, 2005, for use in individuals aged 11 years through 55 years and was approved in October 2007 for children aged as young as 2 years.

“The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, MD, director of FDA's Center for Biologics Evaluation and Research in an FDA news release.