The U.S. Food and Drug Administration said yesterday that MedImmune has addressed problems at its FluMist manufacturing plant in Europe. The move clears the way for the agency to also consider an application requesting that a new version of the influenza vaccine be approved for use in children younger than 5.
In May, the FDA sent a warning letter to the Gaithersburg company and said it would withhold approval of the drug for younger children until problems at the plant, including bacterial contamination, were fixed.
"The firm has satisfactorily addressed the issues outlined in the warning letter," FDA spokeswoman Karen Riley said, adding that "the problems identified at the firm did not affect the safety, purity or potency of any final influenza product."
MedImmune was able to continue operating its European plant, which makes all components for the nasally inhaled FluMist, while it addressed the FDA's concerns. The plant is in the Speke area of Liverpool, England.
FluMist is approved for healthy people ages 5 to 49, but an FDA advisory committee has recommended that its use be expanded to include children between age 1 and 5 who have no history of wheezing, and children 2 and older regardless of wheezing. Younger children are more at risk from flu side effects than older people.
"Our hope and expectation is that we will be able to have the expanded indication this season," MedImmune spokeswoman Karen Lancaster said.
Business analysts have said the vaccine won't be a financial success until its use is expanded to include an older population as well as very young children, who are often shot-averse.