FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

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.

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Video: Late Winter/Early Spring is Meningitis Peak Season: Is Your Preteen or Teen at Risk?

/PRNewswire/ -- What began for Gerald Pe as a pleasant day at the beach quickly turned into a fight for his life and resulted in him losing portions of his feet and suffering organ failure. Lynn Bozof's son, Evan, called home from college to say he had a terrible headache, and within hours was admitted to the Intensive Care Unit; Evan died 26 days later. Gerald and Evan contracted meningococcal disease, more commonly known as meningitis, and your preteen and teenage children may also be at risk. Meningitis peak season is here, and the National Meningitis Association (NMA) is urging parents to get their children vaccinated now to protect them against this devastating disease.

Meningococcal disease is a serious bacterial infection that can lead to death or permanent disability within hours. The disease can be easily misdiagnosed since early symptoms often mimic those of the flu. Given its quick progression and devastating nature, prevention is the best approach to treating meningococcal disease.

"It wasn't until my son, Evan, died that my family learned about a simple vaccination that could have saved his life," said Lynn Bozof, Executive Director of NMA. "Meningococcal disease can strike anyone at any time, but cases peak in late winter and early spring. With meningitis peak season upon us, I encourage parents to speak with their child's healthcare provider about meningococcal vaccination."

Preteens and teens are at greater risk for meningococcal disease, accounting for nearly 30 percent of the estimated 3,000 cases that occur in the U.S. each year. The good news is the majority of these cases can potentially be prevented through vaccination. This is why the Centers for Disease Control and Prevention recommends meningococcal vaccination for all preteens and teens 11 through 18 years of age and college freshmen living in dormitories.

"I knew the meningococcal vaccine was recommended for teens, but I didn't realize how serious meningococcal disease can be or that I was at increased risk so I never made an appointment to get vaccinated," said Gerald Pe, a meningococcal disease survivor. "I almost lost my life to meningococcal disease. I urge you to have your preteens and teens vaccinated now."

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