FDA extends Menactra's age approval
WASHINGTON The Food and Drug Administration has expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10.
The FDA originally approved Menactra back in 2005 for people aged 11 to 55. Now, Menactra joins Menomune as the only vaccines available for children aged 2 and older. Sanofi Pasteur manufactures both drugs.
Meningitis is a serious inflammation of the lining that surrounds the spinal cord and brain. It can result in death or permanent injury to the brain and nervous system. In the United States, about 2,600 people become ill from bacterial meningitis annually. About 10 percent die from the infection and another 15 percent or so suffer brain damage or limb amputation.
Clinical trials of the drug in people ages 2 to 55 years showed that the vaccine produced an immune response one month after vaccination, with little side effects beyond pain at the injection site and irritability.