U.S. Imports 1.2 Million More Flu Shots

German-made vaccine procured under investigational drug application

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By
HealthDay Reporter

TUESDAY, Dec. 7, 2004 (HealthDayNews) -- The United States has procured another 1.2 million foreign doses of influenza vaccine under an investigational new drug (IND) application. All of the doses are expected to be available this month.

This brings the total number of injectable vaccine doses this year up to 59.2 million, with an additional 3 million doses of inhalable FluMist also available. That's still far short of the 100 million the government was initially planning to have before Chiron Inc., one of the two major U.S. distributors, announced the collapse of its intended supply.

"I am very pleased with this scenario," U.S. Health and Human Services Secretary Tommy Thompson said at a press conference Tuesday. "This will allow us to get more vaccine into the hands of those who need it most."

The new vaccine, Fluarix, was made by GlaxoSmithKline in its German plant. Under a protocol worked out with the U.S. Food and Drug Administration, Glaxo has agreed to make up to 4 million doses total available, Thompson said.

Because the new vaccine is labeled "investigational," users will be required to sign a consent form stating that they understand there may be risks involved. Officials said the actual risk is minimal, though.

"It is not investigational because we have real questions about it. It's investigational because the company elected last year not to enter the U.S. market, so they did not apply for approval," said Dr. Lester Crawford, acting commissioner of the FDA. "The public should also know that the vaccine is being used in 30 other countries around the world. The expectation of any real increased risk from this vaccine is very low indeed."

FDA inspectors have physically examined the German facility and have done an extensive review of the manufacturing process. That makes this process markedly different from the practice of importing drugs, which the administration has opposed, Thompson emphasized.

The fortunes of the U.S. flu vaccine market continue to fluctuate. Tuesday's announcement came on the heels of news that Canada may be experiencing its own flu vaccine shortage and, therefore, would not be able to divert supplies to the United States.

Nevertheless, the FDA is still in discussions with two vaccine manufacturers, one in Canada and the other in Switzerland.

And the agency is continuing to investigate other sources of foreign vaccine identified by New Mexico, Illinois and New York City.

The longer-term scenario for the U.S. flu supply may look more hopeful.

Two companies announced this week that they would be entering the U.S. market, one in 2005 and the other possibly two years later.

"By 2007, it is expected that we will have a minimum of four suppliers rather than the one we were forced to deal with this year," Crawford said.

"I'm anticipating next year that we're going to be well ahead of the curve," Thompson added. "Congress has given us $100 million. We're going to be purchasing more vaccine, and we're encouraging more companies to get involved. I'm cautiously optimistic for next year. But for the year after and the year after, I'm very confident that we'll have more companies involved."

Thompson also appeared more sanguine about the nation's food supply Tuesday than he did last week, when he sounded a warning as he announced his resignation. Asked if the nation's food supply was safe, he responded with an unequivocal "yes."

"The food supply is safe, but that doesn't mean somebody, somewhere, sometime could not put some kind of adulterated additives to the food that could cause problems," Thompson said. "I don't want to take anything away from what we have been able to accomplish, but I don't want to leave the stage without also sounding a clarion call that we've got to stay very vigilant about this, because the food supply is an area that is very costly and very important and needs all the protection that it can get."

More information

For more on the flu and the flu vaccine shortage, visit the U.S. Centers for Disease Control and Prevention.

SOURCES: Dec. 7, 2004, news conference with Tommy G. Thompson, U.S. Secretary of Health and Human Services, and Lester Crawford, D.V.M., acting commissioner, U.S. Food and Drug Administration

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