MedImmune Says FluMist Problems Are Solved

MedImmune said last week that it has resolved problems with the manufacturing of its nasal flu vaccine FluMist, clearing the way for the Food and Drug Administration to allow the company to ship the product in time for flu season.

The FDA sent the Gaithersburg firm a lengthy warning letter in May, citing "significant deviations from current good manufacturing practice."

Agency officials were concerned that MedImmune had not properly followed up after excessive levels of mold and bacteria were found during early stages of the production process. The FDA said the vaccine had not been contaminated.

The FDA's warning letter has held up shipments of FluMist. It also put on hold MedImmune's efforts to win regulatory approval for use of the vaccine by children under 5. Expanding the vaccine's use in that important market has been a cornerstone of the firm's efforts to boost the prospects for FluMist, which has not been a hit in the marketplace. It is now approved only for people ages 5 to 49.

FDA and MedImmune officials said the process to win approval for use by younger children could now continue. Less than two weeks before the warning letter was issued, an FDA advisory panel unanimously agreed that FluMist worked in children under 5. The panel was mixed on whether FluMist was safe enough for children younger than 2.

MedImmune spokeswoman Karen Lancaster said company officials "are very hopeful that we are making positive strides in obtaining approval of the lower age indication."

In additional to FDA approval, MedImmune also needs to win a recommendation to use the product in children under 5 from a Centers for Disease Control and Prevention panel. The CDC's advisory committee on immunization practices, which makes recommendations on vaccine use, will not meet again until next month. CDC spokesman Curtis Allen said, "It's possible that they could meet and vote prior to the meeting at the end of October."

Flu season typically begins in November, but vaccination clinics usually open earlier. Lancaster said MedImmune expects to start shipping FluMist at the end of this month. Competitors GlaxoSmithKline, Novartis and Sanofi Pasteur have already had dozens of lots released by the FDA for shipping.

Most of MedImmune's flu vaccine is produced in a British factory in Speke, near Liverpool. The company said it is continuing to work with the FDA on the "ongoing execution of all quality and compliance commitments."

The delay in shipping flu vaccine has been noticeable. In July 2006, the company said it was already shipping FluMist to customers. The company had previously said it expected to have all of its FluMist released by mid-September 2006 for the 2006-07 season.

AstraZeneca, the British drug giant, recently completed its $15.6 billion buyout of MedImmune -- an acquisition it made, in part, to enter the flu-vaccine business. MedImmune is now a subsidiary of AstraZeneca.