FDA Warning Shouldn't Interrupt Flu Vaccine Production

Warning issued to MedImmune Inc. regarding FluMist nasal spray flu vaccine manufacturing issues at a UK plant.

WASHINGTON (AP) - A warning issued to MedImmune Inc. over manufacturing issues at a United Kingdom plant shouldn't significantly disrupt company production of its nasal spray flu vaccine, federal health officials said Tuesday.
The Gaithersburg, Md., company disclosed last week the Food and Drug Administration had issued the warning for deviating from standard practices in its manufacturing of bulk lots of its FluMist vaccine. MedImmune and the FDA both said they were trying to resolve the issue, which involved bacteria and mold contamination at a very early stage of vaccine production. The contamination did not affect finished lots of the vaccine, the FDA said.
The warning means the FDA is delaying approving FluMist for use in children as young as one until MedImmune develops a plan and begins to take corrective action. FluMist already is approved for patients five to 49.
In 2004, the nation's flu-shot supply was abruptly cut in half when British regulators shut down a Chiron Corp. factory because of contamination concerns. FDA stressed its concerns with MedImmune do not rise to that level.
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