Flu vaccine available from Germany, but deal with Canada fails
Wednesday, December 8, 2004
WASHINGTON -- More flu vaccine, this time from Germany, will be available to help alleviate the U.S. crunch, but that still will leave the country with just two-thirds of what was initially expected.
Hopes for a million more doses from Canada have fallen through.
The Food and Drug Administration has been investigating German and Canadian manufacturers of vaccines that are not licensed for the United States to see if the vaccines could be sold here under a special agreement.
The deal is done for 4 million doses of the German vaccine, but the Canadian company is opting to keep its surplus shots at home.
Health and Human Services Secretary Tommy Thompson said Friday his agency had authorized use of a vaccine called Fluarix, manufactured in Germany, and was immediately buying 1.2 million doses. About 250,000 doses already are in hand, he said, and the rest should be available this month.
Thompson also said British manufacturer GlaxoSmithKline had agreed to make another 2.8 million doses available later.
Health officials had been hoping to buy extra vaccine from a Canadian manufacturer, but that company, ID Biomedical, said Tuesday it would sell its extra 1.2 million doses in Canada.
The company had been in negotiations since early October with U.S. public health officials to sell its vaccine here this year. It had hoped this arrangement would help speed safety testing needed to enter the U.S. market on a more widespread basis next year. But company officials recently learned that because of FDA requirements, the process for next year will take just as long as it would have otherwise, so they saw no advantage in selling vaccine now, said Tony Holler, chief executive officer of ID Biomedical.
Staph Bakali, ID Biomedical's chief operating officer, also suggested the surplus vaccine might be needed in Canada, depending on the severity of this year's flu season. "The Canadian government is our most important client and has been a long-term partner of the company," he said Tuesday.
U.S. health officials have been scrambling for flu vaccine for two months now.
They had planned to have more than 100 million doses of the vaccine this season, the biggest supply ever. In October, however, British authorities shut down vaccine maker Chiron Corp., which had planned to ship 48 million doses here, after finding contamination at a Liverpool plant.
Including 4 million doses from Germany, about 65 million doses will be available in the United States this season, including a nasal vaccine appropriate only for healthy people.
The Centers for Disease Control and Prevention has said 98 million people need the vaccine. That includes children, the elderly, babies, pregnant women and anyone with chronic heart or lung disease. Health officials emphasize that only people who fall into high-risk categories should be vaccinated this year.
Separately, Illinois, New Mexico and New York City have located another 650,000 doses from drug wholesalers but have not yet obtained FDA approval to buy the vaccine for residents. Health officials said Tuesday they were working on the request.
Fluarix, the German-made vaccine, has not been licensed for use in the United States and so will be available only as an investigational new drug. That means it can be used, but every patient must sign a consent form acknowledging the possibility of risks.
Before allowing the vaccine into the United States, the FDA inspected the Dresden, Germany, facility where the vaccine was made. The agency also tested whether the drug was effective against the dominant flu strain expected in the United States and made sure the vaccines have been stored properly since they were made.
Health officials have been relieved that the flu season so far has been mild, but they warn the illness does not peak until February, and things could get worse.
Each year, flu kills about 36,000 people in the United States and hospitalizes another 200,000.
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