MONDAY, JUNE 18, 2018

FDA approves meningitis vaccine Bexsero

The U.S. Food and Drug Administration said on Friday that it has approved meningitis vaccine Bexsero.

Bexsero, manufactured by Novartis Vaccines and Diagnostics in Cambridge, Mass., is a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years old.

Bexsero is the second vaccine against this disease approved by the FDA in the past three months.

“With today’s approval of Bexsero, the U.S. now has two vaccines for the prevention of serogroup B meningococcal disease,” FDA Center for Biologics Evaluation and Research Director Dr. Karen Midthun said. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”

Meningococcal disease can be treated with antibiotics, but vaccination is the most effective way to prevent meningococcal disease, which can cause death in some cases.

Three studies evaluating Bexsero’s effectiveness were performed in Canada, Australia, Chile and the United Kingdom, utilizing 2,600 adolescents and young adults, while the safety of Bexsero also was assessed in approximately 5,000 participants in studies in the U.S. and abroad. Common side effects were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue and chills.

With the studies deemed successful, Bexsero was granted breakthrough therapy status, which expedites the development and review of medical products that address a serious or life-threatening condition.

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U.S. Food and Drug Administration (FDA)

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