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FluMist company adds another million doses

Friday, October 22, 2004

WASHINGTON -- A Maryland manufacturer will provide an additional 1 million doses of its FluMist vaccine, making a total of 3 million doses of the nasal spray available, Health and Human Services Secretary Tommy G. Thompson said Thursday, as officials tried to deal with a shortage of flu shots.

However, FluMist, which contains weakened live virus, cannot be used by those at highest risk for flu complications. It is only approved for healthy people aged 5 to 49.

Thompson encouraged health care workers and people who care for high-risk individuals to use the nasal spray.

"It is safe. It is protective and people should avail themselves of that opportunity," Thompson said.

Federal officials had hoped to offer 100 million doses of flu vaccine this year after more than 80 million Americans sought doses last year and 152 children died from the flu.

But in early October, British manufacturer Chiron Corp. was barred from shipping between 46 million and 48 million doses to the United States because of contamination at its Liverpool plant.

Searching for more

Federal officials began searching for additional flu vaccine, asking existing suppliers if they could provide more and asking producers around the world if they had surplus.

On Tuesday, Thompson announced Aventis Pasteur had scrambled to provide 2.6 million extra flu shots, for a total of 58 million doses. The extra vaccine, however, won't be available until January. The flu season typically peaks in January or later.

Between injected and inhaled vaccines and antiviral drugs, enough medicine will be available to treat 100 million people this flu season, officials said. Federal authorities have asked healthy adults to forgo vaccination to leave shots for those at greatest risk: the very young, the very old and people with chronic illnesses.

Gaithersburg, Md.-based MedImmune has the capacity to make 20 million doses of FluMist. Dr. Jim Young, president of research and development, testified before Congress that the company discarded 4 million unused doses of its 5 million doses last year. The company scaled back production this year to 2 million doses.

It restarted its plant this fall to boost this year's production. Beginning the first week of November through early December, MedImmune expects to ship 400,000 doses per week, said David Mott, MedImmune president. People will be charged $16 to $23.50 per dose.

Next year, the company expects again to ramp up production to yield 8 million to 10 million doses of the nasal spray.

The Food and Drug Administration continues negotiations with Canadian flu shot manufacturer ID Biomedical to secure about 2 million doses of their injectible flu vaccine. The government-to-government sale would hinge on the product meeting FDA safety and manufacturing standards, according to Lester Crawford, FDA acting commissioner.

Crawford on Thursday confirmed he's in negotiations with the French government and others to snag 5 million surplus flu vaccine doses around the world.

"Wherever there is flu vaccine, we're in negotiations -- including France," Crawford said.

GlaxoSmithKline continues to negotiate with the FDA, as well, about possibly selling its product, Fluarix, in the United States.

When the company first began making Fluarix, five companies supplied flu vaccine to the U.S. market. Glaxo did not seek FDA approval for its product, focusing instead on international markets "where the need was greater," said Danielle Halstrom, company spokeswoman.

"With the vaccine shortages experienced in the United States for the past two years, we are revisiting that strategy," Halstrom said.

In the meantime, Johns Hopkins University has negotiated for the past two weeks to be able to offer FluMist to its employees.

"We certainly intend to use the FluMist," said Gary Stephenson, director of media relations. Stephenson said the quantity would be determined, in part, by how many flu shots Johns Hopkins can receive. "It's really very premature to discuss this right now."

While adults who take FluMist shed virus for up to seven days and children for up to two weeks, it's a fraction of the virus needed to infect someone, said James C. King, a University of Maryland School of Medicine pediatrics professor who tests vaccines.


On the Net:

Health and Human Services Department: http://www.hhs.gov/flu/


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