FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Research and Development

Australia Recommends Novartis’ Bexsero Meningitis B Vaccine

March 17, 2014
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The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended 0.5 mL doses of Novartis’ Bexsero meningitis B vaccine for young Australians, with an emphasis on children under 2 years, teenagers ages 15-19 and children and adults with medical conditions that place them at higher risk for invasive meningococcal disease, the Swiss pharma company said Thursday. It is the only broad coverage meningitis B vaccine, according to Novartis.

Though meningitis B vaccines that target single strains are in use in countries such as New Zealand, the recommendation says, they are not appropriate for use in Australia, in which multiple strains of the disease are prevalent. Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), ATAGI emphasizes, contains four major antigenic components.

The vaccine was licensed in Australia in August and became available March 5, with a funding decision from the National Immunisation Program pending. It is already approved in the EU and Canada and was recently provided to U.S. university students under an IND exemption.

View ATAGI’s recommendation at www.fdanews.com/ext/resources/files/03/03-17-14-ATAGI.pdf. — Lena Freund

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