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5 million moreflu shots may beon the way

The Bush administration said Thursday it is working to buy another 5 million doses of flu vaccine from manufacturers in Canada and Germany, mixing the ticklish issue of prescription drug imports with the flu shot shortage.
/ Source: The Associated Press

The Bush administration said Thursday it is working to buy another 5 million doses of flu vaccine from manufacturers in Canada and Germany, mixing the ticklish issue of prescription drug imports with the flu shot shortage.

Health and Human Services Secretary Tommy Thompson said government inspectors next week will visit plants where the vaccine is made to assess whether it is safe for Americans’ use.

If the vaccine eventually makes it to this country, patients who receive it would have to sign a form acknowledging they are aware their flu shots come from abroad, Thompson said.

The administration has refused to approve widespread importation of prescription drugs, saying it can’t assure their safety. Sen. John Kerry and other Democratic candidates have used the issue to paint President Bush and the Republican party as too cozy with drug manufacturers, who also oppose drug imports.

But with 48 million doses of flu vaccine, roughly half the anticipated U.S. supply, unexpectedly withdrawn from the market because of bacterial contamination, the administration is scrambling to make up the shortage.

With those 5 million doses, the administration will have found 11 million additional flu shots, roughly a quarter of the shortage, since early October. Thompson said federal agencies are turning in another 300,000 doses that will be shipped to states for use in priority populations — people aged 65 and over, children younger than 5 and the chronically ill.

Vaccines must first be inspected
Thompson said there is a “big difference” between medicines imported by individuals that are not subject to inspections and the flu vaccine.

“This vaccine is going to be inspected by FDA inspectors, based upon efficacy and safety,” Thompson said. “Drugs that are imported into America don’t have that protection.”

Canadian flu shot maker ID Biomedical has just over 1 million doses to sell to the United States, while British drug manufacturer GlaxoSmithKline can provide 4 million doses from a German plant, Thompson said.

At the same time, the FDA is reacting warily to the state of Illinois’ proposal to purchase flu vaccine for its residents from a British wholesaler. Gov. Rod Blagojevich has a tentative deal to buy 262,000 doses of an Aventis Pasteur flu vaccine that was manufactured for use in Canada and Europe.

Blagojevich has asked the FDA for permission to proceed.

Acting FDA Commissioner Lester Crawford said his agency would meet with Illinois officials on Friday to talk about the source of the vaccine and whether the state is willing to back the safety of the flu shots.

Illinois is one of several states to facilitate the importation of cheaper prescription drugs, which the FDA opposes but has not tried to stop.

The FDA asked Aventis Pasteur whether it could provide more vaccine from foreign plants, but was told none was available, an agency official said. The company is producing 58 million doses of flu vaccine for U.S. residents at a plant in Pennsylvania.