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FDA approves expanded label for FluMist

US subsidiary of AstraZeneca, MedImmune, says that the FDA has approved the expanded use of intranasal flu vaccine FluMist in children two to five years of age

US subsidiary of AstraZeneca MedImmune has revealed that the FDA has approved the expanded use of intranasal flu vaccine FluMist in children two to five years of age. 

FluMist is now approved for active immunisation for the prevention of disease caused by influenza A and B viruses in patients aged between two and 49 years. Only one manufacturer had previously been licensed in the US to produce influenza vaccine for children aged less than four years.

MedImmune says it will begin shipping FluMist with the expanded label to healthcare providers imminently so that vaccinations may be offered to eligible individuals ahead of and throughout the upcoming influenza season.

In a study of 4,000 children aged between two and five over the 2004-2005 influenza season, there was a 54 per cent reduction in cases of flu in those treated with FluMist, compared with those who received the traditional flu shot (4.5 per cent versus 9.8 per cent, respectively). In the study, FluMist demonstrated a reduction in influenza rates compared with the inactivated vaccine against strains that were both matched and mismatched to the vaccine.

FluMist has been distributed for use in individuals five to 49 years of age following licensure of the product in 2003 through the 2006-2007 influenza season. The product is different from the flu shot in that it uses live, but weakened forms of the virus within the vaccine to help stimulate an immune response which closely resembles the body's natural response to an influenza infection.

Professor James F Young, president of R&D at Medimmune, said: "With the new, refrigerated formulation approved in January 2006, the results from our head-to-head study published in the February issue of The New England Journal of Medicine, and the expanded age indication now within the label, it is an exciting time for FluMist."

Dr Pedro Piedra of the department of molecular virology and microbiology, and Paediatrics at Baylor College of Medicine, said: "The FDA approval of FluMist for young children is important because these young kids have very high attack rates for influenza, often require medical evaluation for their influenza illness, and can spread the disease easily to others."

19th September 2007

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