Novartis flu vaccine gets EU approval

Novartis has announced that its novel influenza vaccine Optaflu has been approved for use in all 27 member states of the European Union, in addition to Iceland and Norway.

The vaccine is the first to be using the firm’s proprietary cell line for viral antigen components – with standard influenza vaccines produced using chicken eggs – and has been approved as protection against seasonal influenza.

Novartis reports that its innovative cell line production method will facilitate a speedy and more flexible initiation of vaccine manufacturing, putting the firm in a better position to respond in time to the potential threat of an influenza pandemic.

Dr Jorg Reinhardt, chief executive officer of vaccines and diagnostics at Novartis, said: “This vaccine, which is based on our proprietary cell culture technology, would provide for a more flexible and reliable production process, so as to contribute to meeting the ongoing need for seasonal influenza vaccines and the potential need for influenza vaccines in the event of a pandemic.”

He added that the development of Optaflu heralded the first significant innovative step in the manufacturing of influenza vaccines in over half a century.

Novartis originally received a positive opinion from Committee for Medicinal Products for Human Use of the European Medicines Agency regarding the approval of Optaflu in April 2007.