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EU approval for Novartis' pandemic influenza vaccine
10 May 2007
Novartis has furthered its contribution to Europe's preparedness for the expected coming influenza pandemic with the EU approval of its pandemic influenza vaccine Focetria.
Developed in close collaboration with governments and regulatory officials worldwide, Focetria has been formulated to work alongside Novartis' proprietary MF59 adjuvant, which will allow for smaller amounts of antigen to be used within the vaccine.. Upon declaration of an influenza pandemic by the World Health Organization (WHO), Focetria will be manufactured to contain the specified influenza strain. Novartis is also developing a pre-pandemic version, Aflunov, which is awaiting approval in the EU. The news follows on from the US registration last month of Sanofi-Aventis' similar intermediate influenza vaccine..
Novartis is further committed to ensuring public safety by supporting leadership initiatives by the WHO. It has developed a new influenza vaccine manufacturing process utilizing a proprietary cell line, and with the aid of a US $55 million contract with the US Department of Health and Human Services (DHHS), it will further develop the MF59 adjuvant technology.
