FDA is `pessimistic' questioned flu shots will be found safe

U.S. health officials agree with British counterparts that vaccines are tainted

October 09, 2004|By Denise Gellene and Emma Schwartz | Denise Gellene and Emma Schwartz,LOS ANGELES TIMES

WASHINGTON - The acting commissioner of the Food and Drug Administration said yesterday he was "pessimistic" that any flu vaccine made by Chiron Corp. can be cleared for use this season.

Dr. Lester M. Crawford made his comments at a congressional hearing in Washington as a team of FDA officials prepared to inspect Chiron's flu vaccine factory in Liverpool, England, today and tomorrow.

British drug industry regulators on Tuesday shutdown the Chiron factory 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 U.S. supply.

"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 have been forced to ration flu shots because of the shortage of vaccine. Healthy people have been asked to forgo shots so that people with the greatest risks of illness, the elderly, young children, and people with chronic conditions, can get them.

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

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 the Chiron plant.

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

But as recently as last week, the company remained confident that it could deliver between 46 million and 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," he said.

The shutdown of the Chiron plant caught the FDA and Chiron off guard. 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 arranged to meet with Chiron this past Tuesday, before British regulators closed the plant.

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, the British equivalent of the FDA, asked Chiron not to release flu vaccine until it had completed its review of the Liverpool plant, Pien wrote. British inspectors visited the factory between Sept. 28 and Sept. 30, and gave Chiron their written conclusions on Sept. 30. Four days later, on Oct. 4, 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 on Oct. 5.

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," she said. "What was the basis of Chiron's assessment and overconfidence and the miscommunication with the UK 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 last year when it acquired the British company PowderJect. Flu vaccine quickly became Chiron's biggest product. The company increased production at the Liverpool plant this year to produce 52 million doses, up from 34.8 million last year, to meet increased demand for shots while boosting its share of the U.S. flu business to nearly 50 percent from the 27 percent held by PowderJect in 2002.

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 yesterday at $35.63, down 90 cents on Nasdaq. The company has lost $1.8 billion in market value since the suspension was announced.

The Los Angeles Times is a Tribune Publishing newspaper.

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