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MenB Vaccine Approved in Australia

19 August 2013

The Australian Therapeutic Goods Administration (TGA) has added a multi-component meningococcal b (MenB) vaccine to the Australian Register of Therapeutic Goods (ARTG) for use in individuals two months of age and older to protect against meningococcal disease, a leading cause of bacterial meningitis.

Across Australia, approximately 85% of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen. The introduction of vaccines for other strains of bacterial meningitis has been successful in reducing the disease burden in Australia, specifically following the rollout of a national meningococcal serogroup C vaccination program in Australia where cases decreased from 162 in 2002 to nine in 2011.

MenB can easily be misdiagnosed and can kill within 24 hours. Approximately 10% of people who contract the disease will die and many more will be left with devastating, lifelong disabilities such as brain damage, hearing impairment or limb loss.

“Today marks another victory, particularly for Australian children, parents and paediatricians, in the fight against meningococcal disease,” said Bruce Langoulant, President and Asia Pacific Regional Leader, Confederation of Meningitis Organisations.

“We are now entering a critical period for public health authorities to provide funding to include the new MenB vaccine in the routine immunisation schedules to ensure community-wide protection against the tragic deaths and lasting disabilities MenB can cause.”

Next steps will see Australian regulatory authorities working with the vaccine’s manufacturer Novartis, to make the MenB vaccine available in the private market in coming months. At the same time, the Pharmaceutical Benefits Advisory Committee (PBAC), taking into account advice from the Australian Technical Advisory Group on Immunisation (ATAGI), is expected to make recommendations regarding reimbursement and potential inclusion of the vaccine in the National Immunisation Program.

Meningococcal disease is a leading cause of bacterial meningitis. There are different types of meningococcus (called serogroups), of which serogroups A, B, C, Y and W135 are responsible for over 95% of meningitis and septicaemia cases. Prior to this new MenB vaccine there were only vaccines available to protect against serogroups A, C, Y, W135.

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