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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 EMEA. Reportedly, the positive opinion clears the way for EU approval in all 27 member states as well as in Iceland and Norway.
Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunisation 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.
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.
Andrin Oswald, CEO of vaccines and diagnostics at Novartis, said: “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. 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.