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New flu shots approved

The US Food and Drug Administration has approved vaccines for the 2010-2011 flu season covering three strains of flu, including the H1N1 virus

The US Food and Drug Administration (FDA) has approved vaccines for the 2010-2011 flu season. The vaccines all protect against three strains of flu, including the H1N1 virus.

"Last year because the 2009 H1N1 virus emerged after production began on the seasonal vaccine, two separate vaccines were needed to protect against seasonal flu and the 2009 H1N1 pandemic flu virus, but this year, only one vaccine is necessary," the FDA noted.

The approved vaccines for the upcoming season are CSL's Afluria; Novartis' Agriflu and Fluvirin; GlaxoSmithKline's (GSK) Fluarix; ID Biomedical's FluLaval; MedImmune's FluMist; and Sanofi Pasteur's Fluzone and Fluzone High-Dose.

The FDA noted that the labelling of CSL's Afluria has been updated to warn of an increased incidence of fever and febrile seizures in young children. The warning is based on adverse event reports collected after administration of the 2010 Southern Hemisphere formulation of the vaccine. As a result of the reports, CSL will not be supplying the government with the dosage form of the vaccine designed for use in very young children this year. In addition, the FDA is requiring the company to conduct a new paediatric study of the vaccine.

The upcoming flu season will be the first since the US Centers for Disease Control and Prevention (CDC) expanded its recommendation for annual influenza vaccination to include children as young as six months of age. The CDC also is recommending that healthcare providers begin offering flu vaccines as soon as the shots become available.

Sanofi Pasteur said it had begun shipments of Fluzone immediately following the recent approvals, with initial shipments directed primarily to the CDC for use in the federal Vaccines for Children Program. In all, the company expects to deliver 70 million doses of seasonal influenza vaccine to US healthcare providers this season. 

GSK said that distribution of the first lots of FluLaval, its vaccine for adults, had begun, with distribution of Fluarix, which can be used in patients aged three years and older, to follow in the next several weeks.

3rd August 2010

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