FDA expands age range of bacterial meningitis vaccine

23 October, 2007

The United States Food and Drug Administration (FDA) has approved vaccination of children for bacterial meningitis.

The FDA expanded the age range for the vaccine Menactra, made by French pharmaceutical company Sanofi-Aventis, to start from two years of age. Previously, the age range was 11 to 55 years of age.

Bacterial meningitis, an inflammation of the lining surrounding the brain and spinal cord, is a potentially deadly inflammatory infection.

The vaccine Menactra, licensed in the United States for the prevention of meningococcal disease, treats a rare, serious bacterial infection that often causes meningitis or sepsis, a statement from Sanofi-Aventis said.

The vaccine had first received the FDA’s license in 2005 for immunization of adolescents and adults aged 11 to 55. The FDA’s new decision to license Menactra vaccine for children in the age range of 2 to 10 was based on data from two clinical studies.

Dr Jesse Goodman, director of FDA’s Center for Biologics said that “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.”

Sanofi-Aventis makes the other meningitis vaccine as well.

According to the FDA, around 2,600 people fall ill in the United States annually from bacterial meningitis, with 10% dying from it.

The United States Centers for Disease Control and Prevention recommends vaccination for travelers to countries where the infection is a problem, those with damaged spleens, college students living in dorms, and military recruits.

The infection can cause seizures, brain damage, memory loss and death in otherwise healthy people in less than 48 hours, with a 15% fatality rate if treated with antibiotics.

Bacterial meningitis – a relatively rare disease – is marked by fever, headache, and stiff neck and is more serious than viral meningitis.

The vaccine Menactra has been linked with a few cases of a neurological disorder called Guillain-Barre syndrome among some teens.

The Centers for Disease Control and Prevention said it was investigating whether the vaccine caused the reaction, which has been associated with other vaccines, too.

Sanofi-Aventis said that, in the studies, immediate reactions were uncommon and consisted primarily of local redness at or near the injection site.

The vaccine Menactra is manufactured by Sanofi Pasteur, which is the vaccines unit of Sanofi-Aventis.





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