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Flu vaccine shipments halted, raising fear of flu shot shortage

Wednesday, October 6, 2004

From staff and wire reports

LONDON -- U.S. health officials warned Tuesday of major flu shot shortages after British health officials abruptly pulled the license of the maker of half the U.S. vaccine just as flu season was about to begin.

The news means the United States will face "a significant shortage," said Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief. American vaccine experts suggested shots this year would likely be rationed.

British authorities suspended the license of Chiron Corp. for three months because of problems at its vaccine manufacturing plant in Liverpool, England, which primarily supplies the American market. The action means the company can't supply any flu vaccine during that time, and Chiron said it would provide no U.S. vaccine this year.

Chiron Corp. is the company that supplies vaccine for the Cape Girardeau County Health Department and private physicians in the area. LaDeva Enderle, public health nurse and information officer for the health department, said she has no information about the availability of flu vaccines in the county.

"I don't know anything more than what I read on the Internet," she said. "As soon as we know something we will let everyone know."

British officials didn't explain details for the license suspension.

Chiron officials said the British action came because of broad concerns about standards at the Liverpool factory, not just worries about the safety of already produced vaccine.

Howard Pien, president and chief executive of the California-based company, said safety tests on its vaccine were nearly complete, safety concerns seemed to be resolvable, and the company had been talking with the U.S. Food and Drug Administration and its British counterpart about shipping its vaccine.

"The FDA were generally comfortable," but the British agency "has come to a different conclusion," Pien said.

The company has no obligation to recall or withdraw any vaccine, but none has been released anywhere, and none will be this season, Chiron officials said.

U.S. health officials were caught off-guard, learning of the developments only during a midmorning phone call. "We need to regroup," Fauci said shortly afterward.

Chiron had planned to ship 46 million to 48 million doses, but that already had been delayed by a contamination problem discovered in August in the English factory where the vaccine is made. At the time, the company said only 4 million doses were tainted but that the entire supply would be held up and re-tested.

About 1 million doses already had arrived in the United States, but now even that won't be made available because of the British safety concerns.

Pien again refused to identify the contaminant in Chiron's vaccine but said, "It relates to what amounted to human error in a relatively late step in a fairly complicated series of manufacturing procedures."

Flu shot campaigns usually start in October, a month before the flu season typically begins in the United States. In an average year, flu kills 36,000 Americans and hospitalizes another 114,000, mostly the elderly.

Less than two weeks ago, top U.S. health officials assured the public that close FDA monitoring of the rest of Chiron's supply suggested it was fine and that there would be plenty of supplies.

Dr. Walt Orenstein, formerly the top vaccine expert at the U.S. Centers for Disease Control and Prevention and now the associate director of the Emory Vaccine Center, said the government may have to ration available vaccine.

"It's a very serious concern. We're already in October, which is vaccine season. If we have to ration at this stage, it becomes more complicated."

If problems prevent the Chiron vaccine from being used at all this year, it's unlikely that other manufacturers could fill the gap. Aventis Pasteur, which expects to supply 52 million doses, said earlier that federal officials had asked it to make additional vaccine but that it already was at capacity and couldn't produce more until after November when existing orders are filled.

A third manufacturer, MedImmune, which makes FluMist, a new nasal spray flu vaccine for use in healthy 5- to 49-year-olds, said it couldn't produce more than the 1.5 million doses it had planned to make for this year's flu season.

That vaccine is made from modified live virus and isn't considered safe for the elderly or people with medical problems.

Worldwide, Chiron is the second leading flu vaccine manufacturer, behind French pharmaceutical company Aventis, which makes about 45 percent or 50 percent of the world's supply, Stohr said.

Chiron, based in California, makes four influenza vaccines, including Fluvirin, the top flu vaccine in Northern Europe and the No. 2 vaccine in the United States.

The company also has facilities located throughout Europe, the United States and Asia. Fluvirin is also made in the company's plants in Italy and Germany, but those doses have already been promised.

Chiron Corp. officials cut the company's expected profits by more than half Tuesday. Trading in Chiron's stock on the Nasdaq Stock Market was temporarily halted Tuesday morning. Share price dropped $7.69 a share, or 17 percent, to $37.73 after trading resumed.

"Chiron deeply regrets that we will be unable to meet public health needs this season," Pien said. "What happened was unexpected."

The timing of the license suspension is particularly worrying because vaccine production goes in cycles. The manufacturing cycle for the Northern Hemisphere vaccine finished in August and manufacturers are now gearing up to make the shots for the Southern Hemisphere.

Vaccine makers do not have a lot of spare stock because they produce on demand.


Medical writer Marilynn Marchione contributed to this story from Milwaukee; medical writer Lauran Neergaard in Washington and reporter Daniel Yee in Atlanta also contributed to this story.


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