FDA Approves Vaccine to Prevent Meningitis (Meningococcal Disease)

The U.S. Food and Drug Administration recently approved the first vaccine which is designed to prevent Meningitis (Meningococcal Disease) in young children and toddlers. The drug, Menactra, already is approved for use in people ages 2 through 55, is now available for children as young as 9 months.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). According to the FDA statement, the vaccine offers protection against this invasive meningococcal disease caused by Neisseria meningitidis, which is a leading cause of meningitis in young 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 Menactra vaccine is given in two doses spaced about three months apart in children who are at least 9 months old. According to results from the clinical studies, the vaccine produces antibodies in the blood that are protective against the disease.