The Australian Therapeutic Goods Administration (TGA) has granted approval for Novartis' multi-component Meningococcal B (MenB) vaccine, Bexsero, for use against a dangerous form of bacterial meningitis, MenB disease.
The approval will expand access to the vaccine, which has already been cleared in EU in January 2013 against MenB disease, in individuals from two months of age and older.
One of the major cause of meningitis and sepsis globally, MenB disease causes approximately 85% of all meningococcal disease cases in Australia.
A recombinant, adsorbed vaccine suspension for injection 0.5ml pre-filled syringe, Bexsero has demonstrated safety and efficacy in clinical trials in more than 8,000 subjects, including infants, children, adolescents and adults.
Novartis Vaccines and Diagnostics Division head Andrin Oswald said, "We are committed to bringing Bexsero to parents around the globe that want to protect their children against this devastating disease."
Confederation of Meningitis Organisations president and Asia Pacific Regional leader Bruce Langoulant said, "We are now entering a critical period for public health authorities to provide funding to include the new MenB vaccine in the routine immunization schedules to ensure community-wide protection against the tragic deaths and lasting disabilities MenB can cause."
Novartis along with the Australian regulatory authorities will make Bexsero available in the private market in the next few months, while the Pharmaceutical Benefits Advisory Committee (PBAC) is expected to recommend potential inclusion of the vaccine in the National Immunisation Program.
Bexsero is now licensed in more than 30 countries and further regulatory filings are underway.
