Flu Shot Gets New Formulation
By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
September 20, 2005; Page D6
WASHINGTON -- MedImmune Inc. said it has filed an application with the Food and Drug Administration for approval to market a new version of its FluMist influenza vaccine.
The current vaccine must be frozen until just before it is administered, which limits the use by some pharmacies and in public places where flu-vaccine clinics are conducted. The product can only be used by people ages 5 to 49.
MedImmune, of Gaithersburg, Md., is seeking permission to sell an inhaled, refrigerated version to prevent influenza in people ages 5 to 49. The company also is seeking an expanded label to use FluMist in children as young as six months.
"A refrigerator-stable formulation would allow us to significantly expand access to FluMist to many more physicians' offices, clinics and pharmacies than can currently be reached with the frozen formulation," said Edward M. Connor, MedImmune's executive vice president and chief medical officer.
If approved, the vaccine could be available starting with the 2007 flu season. The company said it recently expanded its capacity at its British and Pennsylvania manufacturing plants. The Pennsylvania plant could supply as many as 35 million finished FluMist doses a season and additional capacity could be added, MedImmune said.
The company wouldn't state how many doses of FluMist it expects to sell this year. Last year, the company had said it expected to sell two million to three million doses.
Jamie Lacey, a MedImmune spokeswoman, said distributors will sell FluMist to providers for about $19.95 per dose. Federal health officials have urged healthy children and adults to wait to get a flu shot this year to make sure those in high-risk groups receive a shot. FluMist isn't subject to those recommendations.
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