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FDA eyeing surplus Canadian flu vaccine

| Saturday, Oct. 23, 2004

One more year, and the flu vaccine mess might have been avoided.

ID Biomedical has been working for a year to expand its vaccine manufacturing plant in Quebec. The Canadian company hopes to supply about 38 million flu shots annually to the United States in the future. It might be able to produce an extra 8 million to 12 million shots for next year's flu season.

More immediately, the U.S. Food and Drug Administration is inspecting 1.2 million extra doses at the company's factory for possible shipment to the needy United States for this season, said ID Biomedical spokeswoman Michele Roy.

"They are looking at the situation and evaluating how they could approve the product," Roy said.

ID Biomedical made about 12 million shots for Canada this year, accounting for 75 percent of that nation's supply. The rest came from an Aventis Pasteur factory in France, said spokeswoman Aggie Adamczyk of the Canadian Public Health Agency.

Aventis became the sole supplier to the United States on Oct. 5 when British health authorities shut down Chiron Corp.'s factory in Liverpool. That eliminated 48 million of the 100 million shots U.S. authorities had been expecting. The only other flu vaccine licensed to be sold in the United States is FluMist, a nasal spray made by MedImmune. There are only 3 million doses available because it uses a live virus, which is not approved for people most at risk.

The Aventis vaccine licensed for the United States is manufactured in Swiftwater, in the Pocono Mountains. Typical of the convoluted nature of the business -- which uses chicken eggs to grow the flu vaccine -- the Aventis vaccine approved for Canada is made in France and isn't licensed for use in the United States, even though it's made by the same company.

The vaccine shortage has caused thousands of people, mostly seniors, to queue up in huge lines at flu clinics nationwide. The Allegheny County Health Department's original supply of 14,000 flu shots increased slightly last week when the state gave the county 1,600 doses. The health department gave 2,200 doses to nursing homes and administered 10,494 doses to the eligible public during a four-day clinic.

With about 2,900 doses remaining, health department spokesman Guillermo Cole said the clinic, which reopens at 9 a.m. Tuesday in a tent across Art Rooney Avenue from Heinz Field, might have enough for only one more day. Federal health officials urge people not to wait in long lines in bad weather for flu shots because they risk getting something more serious, such as pneumonia.

About 24 million of the available Aventis shots will be distributed by the federal government in the next eight weeks or so.

Federal health officials are looking for more vaccine from suppliers that aren't licensed in the United States and from other nations, including Mexico, but haven't yet found any, said Tony Jewell, spokesman for the Department of Health and Human Services. That leaves ID Biomedical as the closest supplier with available flu doses.

The Canadian vaccine maker launched a massive expansion of its Quebec factory last November to increase its annual production from 12 million doses to 50 million.

"That is why we have never asked for FDA approval," company spokeswoman Roy said. "We have never had the production capacity to supply, adequately, the U.S. market."

The company's original plan was to start supplying as many as 38 million doses of flu vaccine to the United States in 2007, Roy said. The rest of the company's vaccine will keep going to Canada, with which ID Biomedical has a long-term contract.

Construction on the plant will finish next year, Roy said. Company officials might then try to get at least some of the factory ready to supply vaccine to the United States, rather than wait until 2007 for the whole plant to be finished, Roy said.

ID Biomedical's vaccine could become a critical need because California-based Chiron announced Wednesday that it might not be allowed to make any vaccine for the 2005-06 flu season. Market analysts say the company's warning is probably designed to improve its standing amid lawsuits and a federal probe of its role in the vaccine crisis.

"For this year, our production is finished," ID Biomedical's Roy said. "We cannot start production right now. For next year, we could get organized and provide 8 (million) to 12 million doses."

Three decades ago, there were as many as 25 flu vaccine suppliers in the United States. Mergers and low profit margins have whittled that number to just two.

To guard against shortages, health officials have urged U.S. officials to entice more companies back into the vaccine business, and also to help companies upgrade from the old chicken-egg manufacturing method to a more advanced process that involves growing the virus in a cell culture.

The cell-culture method is quicker and more accurate and would help guard against a worldwide flu pandemic from some form of avian flu. The current method makes it difficult to grow vaccines against avian flu because that sort of virus often kills the chicken eggs.

Cell-culture production is still a long way off, though, Roy said.

"I don't think, in the foreseeable future, we will go to cell cultures," she said. "It's something we're starting. We're in the early stages. ... There are still a lot of unknowns."

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