Novartis (NVS) submits its BLA to the FDA for its Breakthrough Therapy-designated meningitis B vaccine Bexsero (Multicomponent Meningococcal Group B Vaccine [recombinant, absorbed]). The vaccine helps protect adolescents and young adults from ages 10 - 25 against invasive meningococcal disease caused by serogroup B (meningitis B).
Bexsero is the first broad coverage vaccine to help protect against meningitis. It provides protection against the five main serogroups (A, B, C, W-135, Y) of meningocccal bacteria. Prior to Bexsero, serogroup B was unaddressed.
It is already approved in 34 countries including the EU, Canada and Australia. Since the product was launched in 2013, over 500K doses have been distributed.