Flu Vaccine Shortage and Rationing Loom

On Tuesday, U.S. public health officials announced a plan to ration flu vaccine after learning that Chiron Corp. will not provide any of the 46 million to 48 million doses it had been expected to ship. "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 Thompson said in an afternoon conference call with reporters.

The sudden news of the shortage prompted an immediate shift to voluntary rationing. Health officials said the approximately 56 million doses available from other manufacturers should go to: infants six to 23 months old; persons 65 or older; individuals with chronic medical conditions, including AIDS; pregnant women; nursing home residents; children on aspirin therapy; health-care workers who deal with high-risk patients; and those who live with or care for babies younger than six months.

In August, California-based Chiron Corp., which produces the Fluvirin vaccine at a plant in England, announced it was delaying shipment to the United States after several batches were found to be contaminated. Chiron had expected to have the problem solved in time for this year's flu season and had been working with CDC officials, who were confident there would be an adequate supply. But the Britain's Medicines and Healthcare Products Regulatory Agency announced it was pulling the factory's production license for three months -- a decision Howard Pien, Chiron's president and CEO, called "disappointing" and "unexpected."

A team of Food and Drug Administration officials is heading to Britain to investigate. Because none of the contaminated lots was distributed, there is no need for a recall.

HHS had anticipated a total of about 100 million doses of flu vaccine this year. Aventis is expected to provide 54 million. MedImmune Inc. is ready to ship 1 million to 2 million doses of FluMist nasal spray, which can be used by person ages five to 49. Federal officials have asked Aventis to produce more doses, but that is not likely to happen. "At this late stage in the development process, it's extremely unlikely that they would be able to make more," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

CDC Director Dr. Julie Gerberding advised, "Take a deep breath; this is not an emergency. We'll work through this, as we have with other shortages in the past."

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