Novartis' pandemic vacc Focetria gets EU OK

Swiss drug major Novartis says that its influenza vaccine Focetria, which is intended for use following the declaration of an influenza pandemic, has been approved in all 27 European Union member states, as well as by Iceland and Norway. The drug comprises the MF59-adjuvant system, developed by the Swiss company, in combination with influenza virus antigens from strains circulating at the time.

Novartis explained that, once the World Health Organization declares a pandemic, it will begin manufacturing the product to include antigens from the viral strain identified as being responsible. The firm added that inclusion of the MF59 adjuvant should allow the firm to use smaller amounts of viral antigen in the product's formulation, thereby extending supply.

The Basel-headqartered company added that approval is based on the mock-up file it submitted to the European Medicines Agency (EMEA), which included data from formulations of the drug that used the H5N1 and H9N2 influenza virus strains. In a separate submission, Novartis filed a pre-pandemic H5N1 vaccine that incorporates the MF59 adjuvant with the EMEA.