Novartis announced Thursday that Australia's Therapeutic Goods Administration approved the meningococcal B (MenB) vaccine Bexsero for use in individuals from two months of age and older. The company noted that the immunisation "is the first and only broad coverage vaccine to help protect all age groups against MenB disease."
According to the drugmaker, the safety and efficacy of Bexsero was studied in trials involving more than 8000 people, including infants, children, adolescents and adults. Prior to approval of Bexsero, vaccines were only available against meningococcal bacteria A, C, W-135 and Y. Novartis said it will now work with Australian authorities to make Bexsero available in the private market in the coming months. In addition, the Pharmaceutical Benefits Advisory Committee is expected to make recommendations regarding reimbursement and potential inclusion of Bexsero in the country's immunisation programme.
Bexsero was approved in Europe in January, while regulatory filings in other markets are under way. Last month, the UK's Joint Committee on Vaccination and Immunisation (JCVI) adopted an interim position against including Bexsero on routine immunisation programmes after determining the product was unlikely to be cost-effective. At the time, Novartis said it would supply information on pricing before the JCVI's decision is finalised.
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