Novartis has received a positive opinion supporting European Union 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 Union 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 Jorg 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.
Novartis submitted the Focetria mock-up file for EU approval in early 2006. Once the World Health Organization (WHO) declares a pandemic, Novartis will submit a revised application to the European Medicines Agency (EMEA) to incorporate the identified viral strain. This revised application can be approved more quickly than a totally new application. The filing for the Novartis mock-up vaccine was based on clinical studies involving the MF59 adjuvant and different H5N1 strains with pandemic potential.
Separately, Novartis has submitted an MF59-adjuvanted H5N1 pre-pandemic influenza vaccine for EU approval based on the same technology as Focetria. This vaccine is intended for use prior to a pandemic declaration to help prime and boost the immune system of those receiving the vaccine to better defend against infections from a H5N1 virus.
Novartis commitment to pandemic preparedness Novartis is working closely with government and regulatory officials worldwide to support pandemic preparedness efforts. Novartis has engaged in discussions with several governments concerning pandemic influenza vaccine supply and has provided H5N1 vaccines for stockpiling, notably in the US and UK.
Global health authorities have identified H5N1 avian influenza as an aggressive viral strain with pandemic potential. While researchers have not quantified the likelihood of an outbreak, to date H5N1 has caused serious illness in Southeast Asia in more than 250 people.