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Second Vaccine for Serogroup B Meningococcal Disease Wins FDA Nod

Vaccine granted ‘breakthrough therapy’ status

The FDA has approved Bexsero (Novartis Vaccines and Diagnostics Inc.), a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Bexsero is the second vaccine to win regulatory approval in the past 3 months to prevent this disease. The FDA approved the first meningococcal serogroup B vaccine in October 2014. Before these approvals, existing approved meningococcal vaccines in the U.S. covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W.

Meningococcal disease is a life-threatening illness caused by bacteria that can result in sepsis and meningitis. N. meningitidis is a leading cause of bacterial 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 Centers for Disease Control and Prevention, approximately 500 total cases of meningococcal disease were reported in the U.S. in 2012, of which 160 were caused by serogroup B.

Meningococcal disease can be treated with antibiotics to reduce the risk of death or serious long-term problems, but even with immediate medical attention these outcomes are not always prevented, the FDA says. Vaccination is the most effective way to prevent meningococcal disease.

Three studies evaluating the efficacy of Bexsero were conducted in Canada, Australia, Chile, and the United Kingdom in approximately 2,600 adolescents and young adults. Among study participants who received two doses of Bexsero, after vaccination 62% to 88% had antibodies in their blood that killed three different N. meningitidis serogroup B strains in tests conducted in a laboratory, compared with 0% to 23% before vaccination. These three strains represent strains that cause serogroup B meningococcal disease in the U.S.

The safety of Bexsero was assessed in approximately 5,000 participants who received the vaccine in studies conducted in the U.S. and abroad. The most common adverse effects in those who received Bexsero were injection-site pain and swelling, headache, diarrhea, muscle pain, joint pain, fatigue, and chills. In addition, the vaccine’s 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 U.S.

The FDA used the accelerated approval regulatory pathway to approve Bexsero. Accelerated approval allows the agency to approve products for serious or life-threatening diseases based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public.

Bexsero was also granted “breakthrough therapy” status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition.

Source: FDA; January 23, 2015.

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