U.S. faces severe shortage of flu vaccine this winter

British authorities on Tuesday suspended for three months the manufacturing license of the Chiron Corp., a key supplier of flu vaccine to the United States. The California-based company, which manufactures the flu vaccine Fluvirin in Liverpool, England, was to provide 46 million to 48 million doses of influenza vaccine to U.S. health care providers-nearly half of the vaccine that officials at the Health and Human Services agency expected to have on hand during the winter flu season.

The action by British regulators took U.S. officials by surprise. "This is very disappointing news, and creates a very serious challenge," said HHS Secretary Tommy Thompson at a news briefing Tuesday.

On average, 36,000 people die of influenza every year in the United States and another 200,000 are hospitalized. Ninety percent of the deaths and about half of the hospitalizations occur among those aged 65 and older.

The loss of Chiron's vaccine leaves the United States with a supply of about 54 million doses, which are being manufactured by Aventis Pasteur in Swiftwater, Pa. Another two million doses of FluMist nasal spray, manufactured by Maryland-based MedImmune Inc., which is generally not recommended for young children or the elderly, also are expected to be available. The children's vaccine supply will not be affected by the Chiron decision because those doses are manufactured by Aventis.

HHS had planned for about 100 million doses of the vaccine, somewhat higher than last year's demand of about 87 million, when several children contracted influenza and died, fueling a higher demand than usual. Federal officials are requesting that healthy adults forgo getting flu vaccine this year so that those at highest risk for the respiratory disease-young children, the elderly and those with certain health conditions-might receive vaccinations first.

Officials have been aware of manufacturing problems at Chiron's Liverpool facility for several weeks now, but believed the problems would affect no more than several million doses of the vaccine. Early batches were found to be contaminated and had to be discarded. Thompson said he was not sure what the contaminate was. It was not clear what action, if any, the Food and Drug Administration had taken after the contaminated batches were first reported.

The FDA is planning to send a team of scientists to work with their counterparts at the Medicines and Healthcare Products Regulatory Agency in Great Britain to try to resolve the problems, said FDA's Dr. Jesse Goodman, director of the Center for Biologics Evaluation and Research. The FDA must approve all facilities at which vaccine for U.S. consumers is produced. While Chiron manufactures flu vaccine at other facilities in Europe, the Liverpool site is the only one approved for the vaccine production by the FDA.

Chiron president Howard Pien said in a statement, "Chiron deeply regrets that we will be unable to meet public health needs this season." The three-month suspension likely precludes Chiron from providing any vaccine to the United States this winter, since the manufacturing process typically takes about five months.

Janet Heinrich, director of public health issues at the Government Accountability Office, told members of the Senate Special Committee on Aging last week that there is no mechanism in place to ensure that the most vulnerable Americans receive the vaccine first when supplies are limited.

"Because flu vaccine production and distribution largely are private-sector responsibilities, options are somewhat limited," she said. "While CDC can recommend and encourage providers to immunize high-risk patients first, it does not have control over the distribution of vaccine, other than the small amount that is distributed through public health departments."

"It's getting too late in flu season to try to get legal control of the vaccine," Thompson said. "We believe the medical community will respond very faithfully and correctly to our request."

Julie Gerberding, director of the Centers for Disease Control and Prevention, said, "The one thing we know about flu is you can never predict it. It's very difficult to know if it's going to be a bad season or a light season."

"Those things your mother taught you in kindergarten actually do help," she said, "and that includes good hand hygiene."