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Little Hope Seen for Salvaging Vaccine

October 09, 2004|Denise Gellene and Emma Schwartz | Times Staff Writers

The acting commissioner of the U.S. Food and Drug Administration said Friday that he was pessimistic that any flu vaccine made by Chiron Corp. could be cleared for use this season.

Lester Crawford made his comments at a congressional hearing in Washington as a team of FDA officials prepared to inspect Chiron's vaccine factory in Britain this weekend.

British drug industry regulators Tuesday shut down the Chiron factory in Liverpool for three months, citing manufacturing problems that could lead to bacterial contamination of vaccine. The closure meant that Chiron, based in Emeryville, Calif., could not deliver more than 40 million doses of flu vaccine, nearly half the supply for the U.S.

"It is not possible to say that any of them are salvageable at this point," Crawford said. "I'm going to have to present a pessimistic point of view."

Public health officials throughout the nation are being forced to ration flu shots because of the vaccine shortage. Healthy people have been asked to forgo shots so that people who are at greater risk if they contract the flu -- the elderly, young children and those with chronic medical conditions -- can get them.

Chiron and the French drug company Aventis Pasteur are the only suppliers of flu shots to the U.S.

Crawford did not reveal what British regulators found at Chiron's factory. But he later told reporters outside the committee hearing that the FDA "probably would have made the same decision" as British authorities to shut down the vaccine plant.

Chiron announced Aug. 25 that it planned to destroy 4 million doses of flu vaccine because of contamination with Serratia marcescens, a bacterium known to cause urinary tract infections, wound infections and pneumonia. Chiron said then that it expected to delay shipments until October while it investigated the source of contamination.

But as recently as Sept. 30, the company remained confident that it could deliver 46 million to 48 million doses this flu season.

Crawford told reporters that he did not believe that Chiron had intended to mislead regulators or the public: "I think they were acting in good faith."

FDA officials said the shutdown of the plant caught them by surprise, although British government documents indicate that American health officials were informed in mid-September that problems at the plant could disrupt vaccine supplies to the United States, the Washington Post reported.

During the committee hearing, Crawford defended the agency. He said the FDA had its own inspectors in the Liverpool factory when the contamination was found. And he said the FDA had planned to meet with Chiron on Tuesday, the day the plant was ordered closed.

Chiron representatives did not appear before the House Government Reform Committee. But Chief Executive Howard Pien submitted written comments in which he outlined events leading to the closure.

On Sept. 26, the Medicines and Healthcare Products Regulatory Agency, Britain's FDA equivalent, asked Chiron not to release flu vaccine until the agency had completed its review of the plant, Pien wrote. Inspectors visited the factory between Sept. 28 and Sept. 30 and gave Chiron their written conclusions Sept. 30. Four days later, Monday, Chiron sent British authorities a written response.

Chiron believed its letter "had addressed the findings raised by the inspectors," Pien wrote. But the British suspended the factory's license for three months, effective Tuesday.

Pien wrote that Chiron had "learned an extremely painful lesson" and that the company's senior vaccine executives were working with British regulators to develop a "remediation plan." He said the company "deeply and profoundly regrets" its inability to provide vaccine.

Jennifer Chao, an analyst with Deutsche Bank North America, said Chiron still has explaining to do: "While apologies are appreciated, we need a better understanding of the cause of the issue and how Chiron intends to address it. What was the basis of Chiron's assessment and overconfidence and the miscommunication with the U.K. regulatory body?"

Chiron said it had no comment beyond Pien's statement.

Chiron, the world's fifth-largest maker of vaccines, entered the U.S. flu vaccine market in 2003 when it acquired the British firm PowderJect. Flu vaccine quickly became Chiron's biggest product. The company increased production in Liverpool this year to produce 52 million doses, up from 34.8 million last year, to meet increased demand for shots.

Chao said the surge in production "leads us to believe that corners may have been cut to meet the ramp-up."

Chiron's shares closed Friday at $35.63, down 90 cents on Nasdaq. It has lost $1.8 billion in market value since the suspension was announced Tuesday.

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Gellene reported from Los Angeles and Schwartz from Washington.

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