Novartis’ flu pandemic vaccine approved by EU

Novartis, the Swiss pharmaceutical giant, has had its Focetria pandemic influenza vaccine approved by the EU for use in all 27 member states, as well as Iceland and Norway.

Focetria can be adapted to contain an identified viral strain if the World Health Organisation (WHO) declares a pandemic, thereby allowing for a more rapid response.

Scientists have also developed the proprietary adjuvant MF59, which will be included in the human vaccine. According to Novartis, it increases protection with a lower dose of a viral antigen than other vaccines.

When the WHO declares a pandemic, Novartis will prepare and submit an application to the European Medicines Agency to incorporate the identified viral strain into the drug.

"Novartis is pleased with this positive decision by the European Commission for Focetria," said Dr Jorg Reinhardt, chief executive of Novartis Vaccines and Diagnostics.

"The approval of this vaccine, which incorporates our proprietary MF59 adjuvant, marks an important milestone in preparations to combat a potential pandemic threat."

Last week, the EU also approved Novartis’ Sebivo therapy drug as a new treatment for chronic hepatitis B.