CHMP recommends Novartis swine flu vaccine for licensing by EMEA

Swiss drugmaker Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for its Focetria A(H1N1) 2009 monovalent vaccine. This clears the way for approval across the EU, as well as in Iceland and Norway.

Swiss drugmaker Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for its Focetria A(H1N1) 2009 monovalent vaccine. This clears the way for approval across the EU, as well as in Iceland and Norway.

Focetria is an inactivated influenza virus vaccine indicated for active immunisation of persons of six months of age and older against swine flu. It has been developed using traditional influenza manufacturing processes in an egg-based formulation.

The vaccine contains MF59, Novartis" proprietary adjuvant, which has been added to boost the immune response in individuals receiving the vaccine. Novartis says MF59 can elicit protective antibody levels with a dose of 7.5μg of viral antigen compared with 15μg in non-adjuvanted vaccines.

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. "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," said Andrin Oswald, chief executive of Novartis Vaccines and Diagnostics.

"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."

Novartis also plans to begin delivery of its Fluvirin A(H1N1) monovalent vaccine to the US market by early October. The US FDA approved this vaccine on 15 September 2009. Recent clinical trials of Fluvirin conducted in Costa Rica indicate that a single-dose is as effective as a two-dose regime in healthy adults aged 18-64. The trial was conducted in 784 healthy adults.

Companies