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Chiron Optimistic on Next Year's Flu Shot
Posted on 2005-03-03 06:08:00
Chiron Corp. chief executive Howard Pien said Thursday that he was optimistic the beleaguered company will be allowed to produce vaccine for next year's U.S. flu season, but he declined to say how many doses may be delivered. British health regulators on Wednesday lifted a five-month manufacturing suspension at Chiron's Liverpool factory, where roughly half of the U.S. flu vaccine stockpile is usually produced. Chiron had created a public health crisis in October when Britain's Medicines and Healthcare Products Regulatory Agency barred the Emeryville, Calif.-based company from shipping to the U.S. some 48 million doses of its Fluvirin flu vaccine because of contamination concerns.
Pien said the contamination was caused by "human error" and that the company has since overhauled its manufacturing process to the satisfaction of British regulators. Still, the Food and Drug Administration will need to approve of Chiron's manufacturing process before any vaccine can be shipped into the country.
An FDA spokeswoman said Thursday that the agency plans to inspect the plant only after it has begun producing vaccine on a large scale.
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