Vaccine maker to up supply of FluMist

MedImmune now plans to produce 3 million doses amid shortage of flu shots

October 23, 2004|By M. William Salganik | M. William Salganik,SUN STAFF

MedImmune Inc. is bumping up production of its FluMist vaccine for a second time, and now expects to make 3 million doses for this winter's flu season, the Department of Health and Human Services announced yesterday.

MedImmune, based in Gaithersburg, originally made 1.1 million doses for this winter. When flu shot supplies were interrupted by production problems - blocking nearly half of the 100 million doses designated for the United States - MedImmune said this month that it would increase production to 2 million doses. Yesterday's announcement adds another million to that.

The company said it would be able to produce the additional doses at its Philadelphia facility from already available bulk material. The bulk material takes several months to make, limiting the amount that could be produced for this winter.

MedImmune will sell the extra doses through its normal distribution channels, said Tony Jewell, a Health and Human Services spokesman. MedImmune uses a distributor to get the doses to end users such as physicians, hospitals and clinics.

FluMist, a nasal spray made from a modified live virus, is approved for healthy people between the ages of 5 and 49. Those older, younger or ill can be given only the injected vaccine.

In a statement announcing the extra doses of FluMist, Health and Human Services Secretary Tommy G. Thompson said that, along with 58 million flu shots, the supply "gives us the capability to cope with this year's flu season, even if it turns out to be a severe season."

MedImmune said it was not increasing its earnings projections for this year because it was not sure how many of the additional doses would be sold. On Thursday, MedImmune said it expected to sell 1 million to 2 million doses this flu season, yielding $10 million more revenue than it had initially expected in the fourth quarter.

However, the extra production doesn't represent a profit windfall. MedImmune said it needs to sell 6 million to 8 million doses of FluMist before it breaks even. MedImmune sharply cut the vaccine's price this year.

MedImmune said it had had discussions with Thompson and Food and Drug Administration officials about how to expedite inspection and release of the additional doses for this winter.

In a statement, MedImmune said it had also discussed with the Health and Human Services Department and the FDA "what actions would be needed before the end of this year to enable the company to increase its production plan for 2005 from 2 [million] to 3 million doses to 8 [million] to 10 million doses."

On Thursday, MedImmune officials said in a conference call with analysts that it could produce as many as 20 million doses by next winter and 40 million by 2007. How much it decides to produce, however, will hinge on such factors as whether FluMist is approved for use in older or younger people, the availability of injected vaccine and federal regulations governing issues such as whether FluMist must be kept in special freezers.

Shares of MedImmune closed yesterday at $26.34, down 6 cents.

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