Novartis announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Bexsero® (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age. Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule1. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.

In Phase II and Phase III studies, Bexsero demonstrated a protective immune response in adolescents and young adults after two doses. Bexsero also offers a flexible dosing schedule, with the first and second doses administered at least one month apart. The tolerability profile of Bexsero was also demonstrated as part of a US Centers for Disease Control and Prevention (CDC)-sponsored clinical trial conducted in more than 15,000 individuals at Princeton University and the University of California, Santa Barbara (UCSB) during meningitis B outbreaks on these college campuses.

The safety data from the CDC clinical trial are consistent with results observed in previous studies.