The U.S. FDA announced this past week that the vaccine Menactra has been approved for use in children as young as 9 months of age. Previously, the vaccine was approved for use in people ages 2 to 55. Menactra is used in the prevention of invasive meningococcal disease caused by the bacteriaNeisseria meningitidis, a leading cause of meningitis in children. "The highest rate of meningococcal disease occurs in children under one 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, M.D., director of FDA's Center for Biologics Evaluation and Research. The safety of Menactra in this age group was evaluated in four clinical trials in which over 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. Occurrence of fever was comparable to other vaccines routinely recommended for young children. [via FDA]
