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Britain: U.S. Told Of Vaccine Shortage

Flu Shot Records Contradict FDA

By Glenn Frankel and Glenda Cooper
Washington Post Foreign Service
Saturday, October 9, 2004; Page A01

LONDON, Oct. 8 -- British health officials said Friday that their American counterparts were informed in mid-September that problems at a drug manufacturing plant in northwest England could disrupt influenza vaccine supplies to the United States.

Records at Britain's Department of Health show that the plant's owner, Chiron Corp., warned officials of the U.S. Food and Drug Administration and the British Medicines and Healthcare Products Regulatory Agency on Sept. 13 that potential contamination problems remained unresolved at the plant, according to Alison Langley, a senior spokeswoman at the department.

The Chiron vaccine factory in England produces the flu shot. The plant may have contamination problems, which will halt supplies of the vaccine. (Paul Ellis -- AP)

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The British account is at odds with statements by U.S. health officials that they were caught by surprise by the British regulatory agency's decision this week to suspend vaccine manufacturing for three months at the Liverpool plant. It had been expected to provide 48 million doses of flu vaccine to the United States, about half of the U.S. supply this year.

Unlike the United States, health officials in Britain responded to the warning by making "plans by contacting other manufacturers," Langley said.

In Washington on Friday, federal health officials told an emergency hearing in the House Committee on Government Reform that the system for procuring vaccines for the American public has been getting increasingly fragile for years but that none of the proposed solutions are likely to fix the problem quickly.

British officials said there had been regular communication with American public health officials at the FDA and the Centers for Disease Control and Prevention since Aug. 26, when Chiron announced it would delay releasing supplies of the vaccine because about 4 million doses had been tainted.

Jason Brodsky, an FDA spokesman, provided an agency statement disputing the British account, saying: "None of the Center for Biologics Evaluation and Research (CBER) staff who were in regular communication with Chiron since August 25, 2004, were notified by Chiron that there was an increased level of concern regarding the company's investigation of the bacterial contamination."

Furthermore, according to the statement, there had been no communication between CBER and the British agency until that agency suspended Chiron's license. That decision was reached last weekend, and Chiron was informed Tuesday, according to congressional testimony this week.

Britain had been scheduled to receive about 2 million doses of the vaccine, known as Fluvirin, or 10 to 20 percent of its total need.

A British Department of Health statement said officials had already arranged for an additional 1.2 million doses from some of its five other suppliers by the end of the month, with an additional 1 million due to arrive by mid-November.

U.S. officials, by contrast, have said they might not be able to make up the shortfall and urged doctors to give the vaccine only to people who are at highest risk. Influenza kills about 36,000 Americans each year, and as many as 500,000 people worldwide.

A senior British official disclosed this week that the initial cause of the contamination was Serratia marcescens, a potentially dangerous bacterium.

A microbe with a distinctive red pigment, Serratia marcescens is spread by contact with contaminated hands or equipment and was once thought of as harmless, according to Melanie Scourfield of the Society of Microbiologists here.

"It's an opportunistic pathogen that lives in soil and water and has been linked to hospital-acquired infections, dialysis infections and pneumonia," she said.

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