Meningitis is a life-threatening illness commonly caused by bacteria Neisseria meningitidis that infects the membranous coverings of the brain and spinal cord, called meninges. Neisseria meningitidis is a leading cause of meningitis in young children, who are more susceptible to getting this serious illness than are older individuals; FDA clarifies.
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The incidence of Meningococcal disease is estimated to be 1000 to 2600 cases annually in the United States, according to Sanofi Pasteur.
Ten to 15% of people who develop meningococcal disease die of the infection. Another 10% to 20% suffer serious complications; such as brain damage; and loss of function of limb or hearing, according to the FDA.
The highest incidence of meningococcal disease is seen in children under one year of age. With this approval, Menactra can now be used in children as young as 9 months of age.
The vaccine is to be given in 2-doses beginning at the age of 9 months and a booster dose after 3 months.
According to the FDA, the safety of the vaccine had been evaluated on more than 3700 children as young as 9 months in 4 clinical studies .The most common adverse events reported were injection-site tenderness and irritability; and fever.
The Sanofi Pasteur product Web site also notes that "vaccination should be avoided by persons with known hypersensitivity (severe allergic reaction) to any ingredient of the vaccine, including latex (which is used in the vial stopper), or by any persons previously diagnosed with Guillain-Barré syndrome."