FDA approves second meningococcal serogroup B vaccine

FDA has approved a second vaccine for the prevention of meningococcal disease caused by Neisseria meningitides serogroup B for children age 10 years to young adults up to age 25 years.

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Bexsero’s (Novartis Vaccines and Diagnostics) approval comes just three months after Trumenba (Wyeth Pharmaceuticals, a subsidiary of Pfizer) gained approval. According to the FDA, before these approvals, the meningococcal vaccines only helped prevent the disease in four of the five main serogroups of N. meningitides bacteria-A, C, Y, and W.

“The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Meningoccocal disease caused by N. meningitides is the leading cause of bacterial meningitis. In 2012, there were approximately 500 cases of meningococcal disease, and of these, 160 were attributed to serogroup B, according to the Centers for Disease Control and Prevention.

Bexsero’s approval was based on three efficacy studies in Australia, Canada, Chile, and the United Kingdom and safety studies in the United States and abroad. Approximately 2,600 adolescents and young adults participated in the efficacy trials, and of those who received two doses of Bexsero, more than 60% to almost 90% developed antibodies in their blood that can prevent the development of meningitis due to three different N. meningitides serogroup B strains.

The safety trials enrolled about 5,000 participants. Some experienced side effects including pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

“In addition, safety was monitored in more than 15,000 individuals who received Bexsero prior to approval in response to two university outbreaks of serogroup B meningococcal disease in the United States,” the FDA noted.

FDA approved Bexsero under the accelerated regulatory pathway, which allows the agency to approve products for life-threatening diseases based on a reasonable likelihood of clinical benefit.