Head 'em up, move 'em out. MedImmune says it's cleared up its FluMist manufacturing problems, just in time to ship the product for this year's flu season. The FDA had warned the company in May for "significant deviations from current good manufacturing practice" at its U.K. facility, where FluMist is made. At issue were mold and bacteria found in the plant (but not in the vaccine itself).
The manufacturing clearance also opens the way for MedImmune to pursue approval of FluMist in children under five. Just before the manufacturing warning, an FDA advisory panel had said that the company's flu preventive works in that age group, though they were unsure whether it would be safe for kids under two.
- see this release
- and here's the report from The Washington Post
MedImmune wins backing for expanded FluMist use. Report
MedImmune boosted by new data on FluMist. Report
MedImmune touts new FluMist version. Report
FluMist disappoints MedImmune yet again. ReportÂ