Wider Age Range for Meningitis Vaccine
On October 18, 2007, FDA approved expanding the age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years. The vaccine was first approved by FDA in January 2005 for people ages 11 to 55 years.
Until now, Menomune was the only meningococcal vaccine available in the United States for use in children ages 2 and older. Menactra and Menomune are manufactured by sanofi pasteur Inc. of Swiftwater, Pa.
- Meningitis is a potentially fatal inflammation of the lining surrounding the spinal cord and brain. It can cause permanent injury to those organs.
- Each year, about 2,600 people nationwide become ill from bacterial meningitis.
- About 10 percent of those infected die, while about another 15 percent suffer brain damage or limb amputation.
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. This includes children who
- have had their spleen removed or whose spleen is not functioning
- have terminal complement component deficiency, a medical condition that makes it difficult to fight infection
- are expected to travel to areas outside of the United States where the disease is common
Vaccination also is used to control outbreaks of bacterial meningitis.
Safety and Effectiveness
During clinical trials that included people ages 2 to 55 years, Menactra was shown to produce an immune response one month after vaccination.
The most common adverse events reported in the studies were pain at the injection site and irritability. Diarrhea, drowsiness, and lack of appetite also were common.
People who have previously been diagnosed with Guillain-Barré syndrome (GBS), a neurological disorder that causes muscle weakness, should not receive Menactra. GBS has been noted as a possible but unproven risk in some adolescents following immunization with Menactra, occurring in an estimated 1 in 1 million vaccine recipients.
As a precaution, people who have previously been diagnosed with GBS should not receive Menactra. FDA and CDC will continue to monitor the safety of Menactra through the Vaccine Adverse Event Reporting System.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: October 29, 2007