Approval for Meningitis Vaccine Expanded to Include Toddlers
MONDAY, April 25 -- Use of the Menactra vaccine has been expanded by the U.S. Food and Drug Administration to prevent meningitis and other forms of meningococcal disease in children as young as 9 months, the agency said in a news release.
Menactra is already approved to prevent meningococcal disease in people aged 2 years to 55. The deadly Neisseria meningitidis bacteria infect the bloodstream and lining that surrounds the brain and spinal cord. Despite treatment, as many as 15 percent of people who contract meningitis and related diseases die from the infection, the FDA said. As many as 20 percent who survive suffer severe complications, which may include brain damage, loss of limb or loss of hearing.
Infants and toddlers are more susceptible than older people to the illness, which may cause death within hours of onset, the agency said. Early symptoms often are confused with those of the flu.
Menactra was evaluated in four clinical studies involving more than 3,700 infants and toddlers as young as 9 months. The most common adverse reactions included injection-site tenderness, irritability and fever.
Menactra was first approved in 2005 for people aged 11 to 55. In 2007, approval was expanded to include children as young as 2 years. The vaccine is produced by Sanofi Pasteur, based in Swiftwater, Penn.
To learn more about vaccination for meningococcal disease, visit the U.S. Centers for Disease Control and Prevention.
Posted: April 2011