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SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.
The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.
Between 10% and 15% of people who develop meningococcal disease die from the infection, even with appropriate antibiotics and intensive care, while another 10% to 20% suffer such complications as brain damage, loss of limbs and hearing loss.
Menactra already had FDA approval for patients ages 2 to 55 years.