British regulators said yesterday that Chiron Corp. can resume producing flu vaccine at its facility in Liverpool, England, decreasing concern that this season's vaccine shortage will be repeated.
The Emeryville, Calif., firm must still receive a go-ahead from the Food and Drug Administration before it ships shots this fall. The FDA said it would inspect the British plant after it is back in full operation.
British regulators said Chiron can resume flu vaccine production at its Liverpool, England, plant.
(Chiron Corp.)
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_____Background_____
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Flu-Shot Confusion (The Washington Post, Jan 25, 2005)
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After Flu Shot Crisis, Demand Dwindles (The Washington Post, Dec 17, 2004)
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Chiron's Suspension Extended (The Washington Post, Dec 9, 2004)
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Flu Crisis Sparks Fresh Look at Vaccine Production (The Washington Post, Nov 27, 2004)
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U.S. Knew Last Year of Flu Vaccine Plant's Woes (The Washington Post, Nov 18, 2004)
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British Flu Vaccine Is Unusable, FDA Says (The Washington Post, Oct 16, 2004)
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Analysts and former health officials said the British approval was positive news and noted that FDA officials worked closely with their counterparts in Liverpool as they inspected the Chiron plant.
"This is great news," said Walter A. Orenstein, former director of the National Immunization Program at the Centers for Disease Control and Prevention. "They don't yet have FDA approval, but it's a big step in the right direction and hopefully gives us a more secure supply next year."
The company's stock surged on the news, closing up $2.27 at $37.69.
Chiron had to suspend operations and scrap 48 million flu vaccine doses -- about half the U.S. supply -- in October when British regulators discovered some of the vaccines were contaminated with Serratia marcescens, a common bacterium that often causes infections in the lungs and urinary tract.
Chiron's problems, on the eve of flu season, caused federal health officials to scramble for millions of extra flu shots and touched off long and often angry lines of people at drug stores and clinics around the country. The company's troubles also raised renewed questions about the fragility of the nation's flu vaccine supply, which experienced its fourth shortage in five years. Congress held several hearings on the issue.
Ultimately, the shortage turned into a surplus, the result of a mild flu season and millions of people who decided to forgo the hassle of finding shots.
Chiron officials remained largely quiet during the controversy, focusing instead on efforts to decontaminate its facility. British regulators extended the company's suspension in December to give it more time to fix the problems. Yesterday, in a statement, Britain's Medicines and Healthcare Products Regulatory Agency said, "Inspectors have concluded that satisfactory progress has been made in the manufacturing areas which had previously caused concern."
Company officials said it was too soon to know how many doses the Liverpool plant could produce for the next flu season, but it would almost certainly be less than the 48 million doses the firm intended to market this season. Alexander Hittle, an analyst with AG Edwards, said he expected Chiron would produce about 38 million. Elise T. Wang, a Smith Barney Citigroup analyst, predicted 30 million doses.
