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FDA approves first vaccine to prevent serogroup B Meningococcal disease

N. meningitidis is a leading cause of bacterial meningitis.

The FDA approved Trumenba, the first vaccine licensed in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream, and the lining that surrounds the brain and spinal cord. N. meningitidis is a leading cause of bacterial meningitis. The bacteria are transmitted from person to person through respiratory or throat secretions.

According to the Centers for Disease Control and Prevention, about 500 total cases of meningococcal disease were reported in the United States in 2012; of those cases, 160 were caused by serogroup B.

“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, M.D., Director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”

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