FDA Expands Age Range for Bacterial Meningitis Vaccine

November 6, 2007
BioPharm International Editors

The US Food and Drug Administration (FDA) has expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.

The US Food and Drug Administration (FDA) has expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.

First approved by FDA in January 2005, Menactra was initially recommended for people ages 11 to 55 years. Previously, Menomune was the only meningococcal vaccine available in the US for use in children ages 2 years and older. Menactra and Menomune are both manufactured by sanofi pasteur Inc., (Swiftwater, PA) and both offer protection against four groups of Neisseria meningitidis, the bacterium that can cause meningitis.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices currently recommends meningococcal vaccination for children ages 2 to 10 years who are at increased risk of developing meningococcal disease. Vaccination also is used to control outbreaks of bacterial meningitis.

FDA and CDC will continue to monitor the safety of Menactra through their jointly administered vaccine adverse event reporting system.

Meningitis is an 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 US, about 2,600 people become ill from bacterial meningitis annually. About 10 percent die from the infection and another 15 percent suffer brain damage or limb amputation.

FDA releasesanofi pasteur release

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