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Meningitis B Vaccine Bexsero Submitted for FDA Review

Vaccine was used for meningitis outbreaks at U.S. universities

A biologic license application has been submitted to the FDA for marketing approval for the use of Bexsero (multicomponent meningococcal group B vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults aged 10 through 25 years. The submission follows the receipt of a “breakthrough therapy” designation in April.

According to the product’s developer (Novartis), Bexsero is the first broad-coverage vaccine to help protect against meningitis B. The vaccine consists of four key antigen components: fHbp, NadA, NHBA, and OMV Por A.

Bexsero is already approved in 34 countries, including across the European Union, Canada, and Australia. Since its launch in 2013, more than half a million doses have been distributed worldwide.

In the U.S., nearly 30,000 doses of Bexsero were provided to students and staff at Princeton University and the University of California, Santa Barbara, under an “investigational new drug” designation from the FDA following meningitis B outbreaks on those campuses. Further, the Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.

Although rare, meningococcal disease can have serious consequences, including lifelong disability and death within the first 24 hours of symptom onset. The infection is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135, and Y).

Before the development of Bexsero, vaccines were available only for four of the five serogroups of the meningococcus. A vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against these serogroups that together cause most of the meningococcal disease in the world.

The tolerability profile and immunogenicity of Bexsero were established in phase II/III clinical trials involving approximately 8,000 infants, children, adolescents, and adults. No clinically relevant immunologic interference was observed when Bexsero was given concomitantly with other routine infant vaccines. As measured in European countries, Bexsero provides coverage against 70% to 90% of meningitis B strains.

Adverse events seen after vaccination with Bexsero were comparable with those observed after vaccination with other routine vaccines when given alone. Fever — a common event following routine childhood immunizations — occurred more frequently in infants who received Bexsero concomitantly with routine infant vaccines. The fever can be mitigated through prophylactic use of antipyretics.

Sources: Novartis; June 17, 2014; and Bexsero; November 16, 2012.

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