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Data support new meningitis vaccine - US panel
Last Updated: 2004-09-22 15:46:15 -0400 (Reuters Health)
BETHESDA, Maryland (Reuters) - A panel of U.S. experts on Wednesday unanimously agreed that a new Sanofi-Aventis meningitis vaccine has been shown to be safe and effective, but said follow-up data were needed.
The new vaccine, called Menactra, is a longer-lasting meningitis vaccine that the company argued is safe and effective enough to give to children as young as 11. The vaccine is designed to protect them through their vulnerable college years.
The Food and Drug Administration usually follows the advice of its panels of outside experts when deciding whether to approve products.
"Post-marketing surveillance will be a critical part of this vaccine's future," said panel chair Dr. Gary Overturf, a pediatrics professor at the University of New Mexico Medical Center in Albuquerque.
Menactra aims to protect against one of three types of the infection that strikes the fluids surrounding the brain and spinal cord and can lead to seizures, brain damage, memory loss and even death.
The world's third-largest drug maker is seeking U.S. approval to market the vaccine for people ages 11 to 55.
While meningitis often occurs in young children, it also frequently crops up among older teenagers and young adults living in close quarters, including military recruits.
Menomune, the company's other vaccine for meningococcal meningitis, loses effectiveness after three to five years.
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