Flu vaccine shortage and rationing loom

British authorities shut down production plant

Half of expected U.S. supply lost

Health officials scramble to plan for winter needs

October 06, 2004|By Erika Niedowski and Dennis O'Brien | Erika Niedowski and Dennis O'Brien,SUN STAFF

The supplier of half the country's influenza vaccine stunned public health officials yesterday by announcing it would provide no doses this year, prompting immediate fears of a shortage and a scramble to ration the available shots - just weeks before the flu season begins.

Chiron Corp. will provide none of the 46 million to 48 million doses it had expected to ship this month to the United States; a British regulatory agency unexpectedly yanked the company's production license and blocked it from releasing the vaccine.

"This is very disappointing news that creates a serious challenge to our vaccine supply for the upcoming flu season," U.S. Secretary of Health and Human Services Tommy G. Thompson said in an afternoon conference call with reporters.

The loss of half the country's flu vaccine supply - at a moment's notice - resulted in an immediate change in federal recommendations on immunization that hinges on voluntary rationing.

With the vaccine in short supply, health officials said, it should first go to people at highest risk of complications from the flu: those 65 and older; those with chronic health conditions such as kidney disease or AIDS; pregnant women; children 6 months to 23 months old; and health care workers.

Healthy people should skip flu shots unless more doses become available, officials said.

Triage for shots

"Our immediate focus will be on making sure that the supply of vaccine that we do have reaches those who are the most vulnerable," said Thompson.

Still, depending on the severity of this year's flu season, the estimated 56 million doses that are available might not be enough to cover everyone who most needs protection.

"The one thing you can be certain with influenza is that you can't really predict what's going to happen," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. With the available vaccine supply, he said: "I think we'll at least come close."

There will be adequate doses for children younger than 2, because they are being supplied by the other major manufacturer, Aventis Pasteur.

California-based Chiron, which produces the Fluvirin vaccine at a plant in England, announced in August that it was delaying its vaccine shipment to the United States after several batches were found to be tainted.

But the company had expected to have the problem resolved in time to provide vaccines for this year's flu season. It had been working closely with officials at the federal Centers for Disease Control and Prevention in Atlanta, who were confident there would be an adequate supply.

Chiron President and CEO Howard Pien called the decision yesterday by the Medicines and Healthcare Products Regulatory Agency - Britain's equivalent of the Food and Drug Administration - to pull its production license for three months "disappointing" and "unexpected."

In a conference call, Pien said the company believed it had found the cause of the original contamination - which he attributed to human "handling error" - and said that Chiron would work with British regulatory officials to resolve any outstanding issues.

"Frankly, we still don't know what it is that they found" in a recent inspection of the plant, Fauci said of British regulators.

A team of FDA officials is heading to Britain to investigate.

Because none of the contaminated vaccine lots produced by Chiron was distributed, there is no need for a recall. The company's stock fell 16 percent yesterday, to $37.98.

The U.S. Health and Human Services Department had anticipated a vaccine supply of about 100 million doses this year. Of that number, Aventis is expected to provide 54 million. MedImmune Inc. is also ready to ship 1 million to 2 million doses of its new FluMist nasal spray, which can be used only by those ages 5 to 49.

Federal health officials said yesterday that they had asked Aventis if it could produce more doses, but that probably won't happen. Vaccine production for the Northern Hemisphere's winter flu season begins in spring and takes several months.

"[Aventis] may be able to find some doses that they had not designated for us ... but at this late stage in the developmental process, it's extremely unlikely that they would be able to make more," said Fauci.

Aventis officials did not return phone calls seeking comment.

36,000 deaths a year

Anywhere from 5 percent to 20 percent of the U.S. population gets the flu every year, according to the CDC. More than 200,000 are hospitalized, and 36,000 die from it.

Though an estimated 180 million people could benefit from getting vaccinated, nowhere near that number roll up their sleeves to get the shot. Last year, about 87 million people were immunized. Flu season generally runs from late October into March.

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