Novartis announced that Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The positive opinion clears the way for European Union approval in all 27 Member States as well as in Iceland and Norway. This announcement marks a significant milestone in bringing a pandemic vaccine to market in Europe.

Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus. The pandemic vaccine has been developed using traditional influenza manufacturing processes in an egg-based formulation. Focetria contains MF59, Novartis proprietary adjuvant, which has been added to boost the immune response in individuals receiving the vaccine. MF59 can elicit protective antibody levels with a lower dose, just 7.5 micrograms of viral antigen versus 15 micrograms in non-adjuvanted vaccines, potentially resulting in greater vaccine supply.

Novartis has already started first deliveries of pandemic vaccines under quarantine to governments in Europe, despite the initially low yields with the current production seed strain provided by the World Health Organization (WHO). A new seed strain could provide higher volumes.

"Only three months after the declaration of the pandemic by the WHO, Novartis was able to ship the first batches of our pandemic vaccine under quarantine to governments in Europe pending EU approval," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "This CHMP positive opinion paves the way for EU approval, which will allow governments to begin their vaccination campaigns with the goal of reaching more patients before the rapidly spreading virus reaches them. Several recent clinical trials suggest that just one dose of pandemic vaccine can protect healthy adults, which means that now the vaccine can be provided to more people than if two doses were needed."

Focetria was previously approved by the EU in May 2007 as a mock-up file to be used once the WHO declared a pandemic. This previous approval was based on clinical studies involving the MF59 adjuvant and different influenza strains with pandemic potential, including H5N1 and H9N2.

Novartis also plans to begin delivery of its Fluvirin A(H1N1) monovalent vaccine to the US market by early October. The US Food and Drug Administration approved this vaccine on September 15, 2009. Data derived from recent clinical trials of Fluvirin conducted in Costa Rica indicate that a single-dose regimen is as effective as a two-dose regime in healthy adults ages 18-64 suggesting the potential to extend A(H1N1) vaccine supply further to support public health efforts. The trial was conducted in 784 healthy adults.

Novartis proprietary MF59 adjuvant has an established safety profile, supported by more than 12 years of clinical safety data and more than 40 million doses of commercial use in Europe. The adjuvant has been studied in clinical trials involving more than 26,000 people, including children, and has been licensed for use in people 65 years of age and over in the seasonal influenza vaccine, Fluad, since 1997 in the European Union. Fluad is not licensed for sale in the US.