Novartis pandemic flu vaccine gains EU approval

Novartis has announced that human vaccine for influenza Focetria has been approved for use in the European Union. The compound has been designed for use after the declaration of a pandemic of the disease.

The company reports that the vaccine will now be manufactured and stockpiled for use at an appropriate juncture – the announcement of a pandemic by the World Health Organisation.

Meanwhile, approval for the vaccine includes the production MF59, an adjuvant that can potentially enable the use of smaller amounts of viral antigens in each vaccine dose as a means of extending supplies.

Novartis has additionally reported the filing of a pre-pandemic H5N1 influenza vaccine based on the same technology as Focetria – one also including MF59 – for the purpose of boosting the human immune system in a pre-pandemic environment.

Dr Jorg Reinhardt, chief executive officer of vaccines and diagnostics at the company, said: “Novartis is pleased with this positive decision by the European Comission for Focetria.”

He added that a key landmark had been met in the preparations to tackle a global influenza pandemic through the approval of the vaccine and its adjuvant.

In December 2006, Novartis announced the relocation of its vaccines business unit to Cambridge, Massachusetts, with staff from a number of sites – including its Oxford, UK facility – to be given the option to work at the new headquarters of the division.