FDA Approves New Meningococcal Disease Vaccine

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FDA Approves New Meningococcal Disease Vaccine
FDA Approves New Meningococcal Disease Vaccine

(HealthDay News) -- The Bexsero vaccine has been approved by the U.S. Food and Drug Administration to prevent serogroup B meningococcal disease among people aged 10 through 25.

Some 500 cases of bacterial meningitis were recorded by the U.S. Centers for Disease Control and Prevention in 2012, of which 160 were caused by serogroup B, the FDA said.

Bexsero was clinically evaluated among some 7,600 adolescents and young adults. The most common side effects were injection-site swelling and pain, headache, diarrhea, muscle and joint pain, fatigue, and chills.

"With today's approval of Bexsero, the United States now has two vaccines for the prevention of serogroup B meningococcal disease," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease."

Bexsero is manufactured by Novartis Vaccines and Diagnostics, based in Cambridge, Mass.

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