FDA expands FluMist approval
US cancer, infectious and inflammatory diseases specialist MedImmune, which was recently purchased by AstraZeneca (Marketletters passim), says that the Food and Drug Administration has extended its approval of the intranasal influenza vaccine FluMist to include children aged two and over.
The agency based its decision on data from a pivotal study that recruited 4,000 children aged two to five during the 2004-2005 influenza season. The program showed that there was a 54% reduction in cases of flu in treated-children in comparison with those who received the traditional flu shot, 4.5% versus 9.8%, respectively.
MedImmune said that it will begin shipping FluMist with the expanded labeling to health care providers in the coming days in time for the impending flu season.
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