Novartis flu vaccine close to EU approval

Novartis has received a positive opinion supporting EU regulatory approval of the human vaccine Focetria for use in the event of a pandemic influenza outbreak.

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of this new vaccine and the EC is likely to deliver its final decision within two to three months.

The EU submission for Focetria was considered a "mock-up" since it lays the groundwork for a more rapid approval and availability of a specific vaccine once a pandemic has been declared.

Focetria would be manufactured to contain the pandemic influenza strain declared at the time of a pandemic along with the proprietary adjuvant MF59 developed by Novartis.

Studies have shown that MF59 could boost the body's immune response to the vaccine's active constituent and extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive.

The filing was made in early 2006. Once the World Health Organization declares a pandemic, Novartis will submit a revised application to the European Medicines Agency (EMEA) to incorporate the identified viral strain. This revised application can be approved more quickly than a totally new application.

Novartis has submitted a separate MF59-adjuvanted H5N1 pre-pandemic influenza vaccine for EU approval based on the same technology as Focetria. This vaccine is intended for use prior to a pandemic declaration to help prime and boost the immune system of those receiving the vaccine to better defend against infections from a H5N1 virus.