Meningitis Vaccine Approval Moves Forward
Panel Calls Vaccine Safe, Effective but Wants Longer Studies
Sept. 24, 2004 -- An FDA advisory committee has recommended licensure for a new meningitis vaccine called Menactra. According to its maker, Sanofi-Aventis Group, the vaccine was shown to be safe and well tolerated.
Although the FDA is not bound by the advisory committee's recommendation, the agency considers it carefully when deciding whether to license a vaccine for marketing.
However, the advisory panel says Menactra should undergo more clinical studies if it is approved, according to news reports.
Menactra is designed to protect against four subtypes of bacteria that cause meningococcal diseases, and is designed to give longer-lasting immunity than the currently available vaccine.
Menactra is intended for children and adults aged 11-55, according to Sanofi-Aventis. At around age 15, the incidence of meningococcal disease increases, although the risks are not nearly as high as those seen in the highest risk group -- those less than one year.
Meningococcal infection can spread among young adults living in close quarters, such as college dormitories. The infection is acquired after contact with an infected person. Contact including kissing, sharing food or beverages, or staying in the same house or room (including a classroom) for more than a few hours a day can increase a person's risk of getting an infection.
In studies by Sanofi-Aventis, one dose of Menactra protected students throughout their college years.
Fewer than 3,000 Americans per year get invasive meningococcal diseases. The bacteria can cause meningitis (inflammation of the lining of the brain) or sepsis (an infection of the bloodstream). Symptoms include stiff neck, headache, fever, and drowsiness. Sepsis can lead to fever, shock, coma, and death. Most cases of infection are not fatal; nearly 10% of people who get meningococcal diseases die.
Up to 15% of survivors have long-term problems, which can include paralysis, hearing loss, and mental disability.
Menactra's structure, says Sanofi-Aventis, is different from the current vaccine, Menomune, which was licensed in 1982. These differences result in longer-lasting protection offered by the new vaccine, say Sanofi-Aventis officials, in a news release.