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FDA announcement on importing flu vaccine from Europe, Canada expected next week

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The Food and Drug Administration will announce next week whether flu vaccine can be imported from Europe and Canada to bolster dwindling U.S. supplies, according to a statement released by Health and Human Services Secretary Tommy Thompson.

FDA scientists have inspected foreign vaccine plants and may permit 5 million-6 million flu shots to be licensed under an experimental drug designation.

In the past six weeks, 17.2 million doses of flu vaccine have been shipped to health agencies serving people at the highest risk of flu complications as part of a national program to direct vaccine to those who need it most.

The supply, which had been expected to be about 100 million doses, was cut nearly in half when manufacturer Chiron's license was suspended because of contamination in the vaccine.

The shortage led the governors of Illinois and New Mexico and New York City Mayor Michael Bloomberg to arrange to buy through an overseas distributor 650,000 doses made by Aventis and GlaxoSmithKline for Europe. That vaccine also must be cleared by the FDA, a step the governors say is being stymied by Aventis.

In a letter sent Monday to Aventis CEO David Williams, Govs. Rod Blagojevich of Illinois and Bill Richardson of New Mexico say the company has not responded to an FDA request made Oct. 29 for information needed to approve the vaccines for use in the USA. GlaxoSmithKline has agreed to provide the data, the governors say, but ''Aventis has yet to cooperate.''

Aventis spokesman Len Lavenda would not comment on the nature of the governors' charge. ''We are working with the FDA to assess issues related to the importation of our influenza vaccine,'' he said.

The Centers for Disease Control and Prevention is reallocating what remains of the flu vaccine supply to ensure that it goes to those at highest risk, including 6- to 23-month-old babies, people with medical conditions and those older than 65.

A survey has found that a ''small number of states'' have more doses than they need for their at-risk populations, said Lance Rodewald of the CDC, and extra doses will be redirected to states with shortages. But it's estimated there are 90 million people in the highest-risk groups, and there will not be enough vaccine for all, he said.

''The real race is to get as many high-risk individuals vaccinated before the epidemic hits,'' Rodewald said, ''and we don't know when the epidemic will come.''

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