SILVER SPRING, Md., April 24 (UPI) -- A vaccine against meningococcal disease has been approved by the U.S. Food and Drug Administration for children as young as 9 months, officials say.
Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, says neisseria meningitidis is a leading cause of meningitis in young children -- it progresses rapidly and can cause death within hours although early symptoms are often difficult to distinguish from influenza and other common illnesses.
Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop the disease die and another 10 percent to 20 percent suffer complications such as brain damage or hearing loss, Midthun says.
The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine.
The most common adverse events reported in the youngest study participants were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children, Midthun says.
Menactra, manufactured by Sanofi Pasteur Inc., was originally approved January 2005 for use in those ages 11-55 years and was approved in October 2007 for children age 2 and older.
