You are here

FDA Approves First Vaccine to Prevent Meningococcal Disease in Infants, Toddlers

April 28, 2011 -- The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

For more information:

Menactra Product Page

Recent Headlines

Patients Had Improved Lung Function, Fewer Exacerbations
Particularly Serious: Antidepressants, Drugs for Parkinson’s and Epilepsy
Drug “Remarkably Effective” at Killing Range of Gram-Positive Bacteria
Up to 70% Greater Risk of Bacterial Infection, 48% Risk for Fungal Infection
Most Women Undergoing Surgery for Suspected Cancer Do Not Have It
Specific Monoclonal Antibodies Ensure Extreme Sensitivity, Accuracy
Record-High Number of Cases in France, Italy, Greece, Other Locations
Will Have a Longer Shelf Life Than Current, Expired Stockpile