The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.
Previously, the vaccine was approved for use in people ages 2 through 55 years.
Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.
"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," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.
The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.
Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.