MONDAY, JUNE 18, 2018

Novartis announces Australian approval of meningococcal B vaccine

Novartis, a Basel, Switzerland-based healthcare solutions company, announced on Thursday that the Australian Therapeutic Goods Administration added the company's meningococcal B vaccine to the Australian Register of Therapeutic Goods.

Bexsero, Novartis' multi-component MenB vaccine suspension for injection, was approved for use in individuals two months of age and older. The vaccine is the first and only broad coverage vaccine to help protect all age groups against MenB, including infants.

"Novartis welcomes the Australian health authorities' decision to license Bexsero, which is further testament to the vaccine's demonstrated robust efficacy and safety profiles and an important step in preventing further suffering caused by MenB disease," Andrin Oswald, the division head of Novartis Vaccines and Diagnostics, said. "We are committed to bringing Bexsero to parents around the globe that want to protect their children against this devastating disease."

In Australia, approximately 85 percent of all meningococcal disease and sepsis cases are caused by MenB. MenB is a possibly deadly disease that is easily misdiagnosed and can kill within 24 hours of onset. Approximately one in 10 individuals who contract the disease will die despite treatment and up to one in five survivors may suffer from life-long disabilities like hearing impairment, limb loss and hearing impairment.

"Today marks another victory, particularly for Australian children, parents and pediatricians, in the fight against meningococcal disease," Bruce Langoulant, the president and Asia Pacific regional leader of the Confederation of Meningitis Organisations, 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."

Going forward, Novartis will work with Australian regulatory authorities to make Bexsero doses available in the private market in the coming months.

Five main groups of meningococcal bacteria cause most of all cases of bacterial meningitis around the world. Before Bexsero, vaccines were only available against the other four strains: A, C, W-135 and Y.