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Published on 27 September 2010

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Flu vaccine positive opinion from CHMP

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Novartis announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Aflunov, an investigational pre-pandemic avian influenza vaccine.
The CHMP is endorsing the approval of Aflunov for active immunization against H5N1 subtype of Influenza A virus in adults 18 years of age and older. H5N1 (commonly referred to as avian or bird flu) accounts for most avian influenza outbreaks globally and is a serious health concern given its potential to evolve into a deadly pandemic strain at any time.

The CHMP recommendation serves as the basis for a European Commission licensing Decision. Based on the CHMP recommendation, a marketing authorization for Aflunov could be granted in all the European Union and EEA countries. The marketing authorisation is expected to be granted before year-end.

“Upon approval, we expect Aflunov to be an important addition to our portfolio of pandemic preparedness solutions,” said Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division.

“The onset of a pandemic can be very rapid, leaving little or no time to prepare. Vaccinating in advance may prevent the potential devastation of a pandemic outbreak.”

H5N1 is presently the virus of greatest concern among all avian influenza viruses. H5N1 is currently circulating in birds, poultry and many other animal species around the world and has already infected humans that have been in contact with infected animals. While human infections are continuing to rise, ability of the virus to spread from human to human has not been demonstrated yet. To date, there have been more than 500 cases of serious illness and more than 300 deaths. H5N1 morbidity and mortality rates remain significantly higher than those associated with seasonal influenza and any recent pandemic. According to the World Health Organization (WHO), H5N1 has met all prerequisites for starting a pandemic except for the ability to spread efficiently and sustainably among humans.

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