MedImmune Warning Won't Disrupt Vaccine Production: FDA
A warning issued to MedImmune over manufacturing issues at a United Kingdom plant shouldn't significantly disrupt company production of its nasal spray flu vaccine, federal health officials said.
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 1 until MedImmune develops a plan and begins to take corrective action.
FluMist already is approved for patients 5 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.
"It is different from Chiron in that again, we do not have a product failure at this point," Mary Malarkey, director of compliance and biologics quality in the FDA office that oversees vaccines, told reporters.