Approval of Focetria, an immune enhancing pandemic influenza vaccine, would allow for more rapid response in the event of influenza pandemic.
Novartis announced today that it has received a positive opinion supporting European U nion regulatory approval of the human vaccine Focetria? for use in the event of an pandemic influenza outbreak, such as one that could be caused by the H5N1 virus.
The Committee for Medicinal Products for Human Use (CHMP), which reviews applications for all 27 countries in the European U nion as well as Iceland and Norway, has recommended approval of this new vaccine. The European Commission generally follows the recommendations of the CHMP and delivers its final decision within two to three months.
The EU submission for Focetria was considered a “mock-up” since it lays the groundwork for a more rapid approval and availability of a specific vaccine once a pandemic has been declared.
Focetria would be manufactured to contain the pandemic influenza strain declared at the time of a pandemic along with the proprietary adjuvant MF59 developed by Novartis. Studies have shown that MF59 could boost the body’s immune response to the vaccine’s active constituent and extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive.
“The availability of a pandemic influenza vaccine soon after the declaration of a pandemic is essential to reduce disease burden and deaths. This positive recommendation for our proprietary MF59-adjuvanted pandemic vaccine brings us one step closer to achieving public health and pandemic preparedness goals,” said Dr. J?rg Reinhardt, CEO of Novartis Vaccines and Diagnostics, a division of Novartis.
“We are committed to working with governments and international organizations to reduce the impact of an influenza pandemic through ongoing research and development projects for pre-pandemic and pandemic influenza vaccines,” Reinhardt said.