Focetria, a new human vaccine designed for use following the declaration of an influenza pandemic, has received European U nion approval in all 27 member states as well as Iceland and Norway.
Focetria will be manufactured to contain the influenza strain declared at the time of a pandemic by the World Health Organization (WHO). It will also include the proprietary adjuvant MF59, which was developed by Novartis and could extend the vaccine supply by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive.
“Novartis is pleased with this positive decision by the European Commission for Focetria,” said Dr. J?rg Reinhardt, CEO of Novartis Vaccines and Diagnostics, a division of Novartis. “The approval of this vaccine, which incorporates our proprietary MF59 adjuvant, marks an important milestone in preparations to combat a potential pandemic threat.”
Once the WHO declares a pandemic, Novartis will submit a revised application to the European Medicines Agency (EMEA) to incorporate the identified viral strain. The Focetria mock-up file submitted for EU approval in early 2006 was based on clinical studies involving the MF59 adjuvant and different influenza strains with pandemic potential, including H5N1 and H9N2.
Separately, Novartis has submitted for European U nion approval a pre-pandemic H5N1 influenza vaccine incorporating the MF59 adjuvant and based on the same technology as Focetria. This vaccine is intended for use prior to the declaration of a pandemic to help bolster the immune system of those receiving it to better defend against infections from a H5N1 virus.