FDA OKs Meningitis Vaccine for Kids 2-10

Oct. 23, 2007 -- The FDA has expanded the age range for Menactra, a bacterial meningitis vaccine, to include children aged 2-10.

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.

Each year in the U.S, about 2,600 people become ill from bacterial meningitis. About 10% die from the infection and about 15% suffer brain damage or limb amputation, according to the FDA.

The FDA first approved Menactra in January 2005 for people aged 11-55. Previously, Menomune was the only meningococcal vaccine available in the U.S. for use in children age 2 and older.

Both products are made by Sanofi Pasteur Inc. Both vaccines offer protection against four groups of Neisseria meningitidis, a bacterium that can cause meningitis.

Both vaccines work well and protect about 90% of those who get it, but Menactra is expected to give better, longer-lasting protection, according to background information on the CDC's web site.

"Approving Menactra for younger children offers another option for health care providers and parents. Now there are two vaccines available for children between 2 and 10 years of age who may be at increased risk of meningitis," says Jesse Goodman, MD, MPH, in an FDA news release.

Goodman directs the FDA's Center for Biologics Evaluation and Research.

The CDC recommends meningococcal vaccination for children aged 2-10 who are at increased risk of developing meningococcal disease, such as:

• Children who have had their spleen removed or whose spleen isn't functioning.
• Children with a medical condition called terminal complement component deficiency, which makes it difficult to fight infection.
• Children who expect to travel to areas outside of the U.S. where meningococcal disease is common.

Vaccination is also used to control outbreaks of bacterial meningitis.

Menactra’s effectiveness was measured in clinical trials that included people aged 2-55. The vaccine was shown to produce an immune response one month after vaccination.

Menactra's safety was evaluated in eight clinical studies that included some 10,000 patients who received Menactra and more than 5,200 others who received Menomune. 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, according to the FDA.

While not observed in these clinical trials, Guillain-Barré syndrome (GBS), a neurological disorder that causes muscle weakness, was noted as a possible but unproven risk in some adolescents following immunization with Menactra.

Those cases occur in an estimated one in a million vaccine recipients, states the FDA. As a precaution, people who have previously been diagnosed with GBS should not receive Menactra.

The FDA and CDC will continue to monitor Menactra's safety through their jointly administered Vaccine Adverse Event Reporting System.