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The FDA is examining the nasal spray MedImmune for use in children under the age of five, and has reported that it is effective, although it increases respiratory problems.
The vaccine marketed as Flumist, had great potential, but has experienced only modest sales after being limited for use only on healthy people between the ages of 5 and 49.
MedImmune want to start marketing the drug towards young children, and is hoping top get FDA approval as this could mean a major revenue boost for the company. Current Govt. recommendations call for the flu vaccine to be given to all children between 6 months and 6 years of age, so the available market is immense.
The drug sold just 36.4 million last year, which is well behind their top selling drug Synagis, which earned 1.1 billion dollars in sales last year.
The FDA has reported that the drug is effective in preventing influenza, but does cause more wheezing problems among young children compared to those that were injected with the vaccine; and 3% of children who took the nasal vaccine were hospitalized for respiratory problems compared with just 1% with the injected vaccine.
These respiratory problems have not caused any deaths, but the FDA is seeking council from a panel of outside experts as to whether these increased side effects warrant limiting the use of the drug on very young children.
The company has recently received FDA approval on a variation of their popular drug Flumist that can be stored in a refrigerator instead of a freezer. This will expand the usage potential and should be available by 2008.
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