First Vaccine Approved by FDA to Prevent Serogroup B Meningococcal Disease

The vaccine is named Trumenba.

The FDA has announced the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in individuals 10 through 25 years of age.

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). The bacteria are transmitted from person to person through respiratory or throat secretions (e.g., by coughing, kissing, or sharing eating utensils). According to the CDC, 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 Dr. Karen Midthun, M.D., director of 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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