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Spokane, Washington  Est. May 19, 1883

Chiron optimistic it can make flu vaccine for next winter

Associated Press

BERKELEY, Calif. — 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.

“We are moving full force ahead,” Pien said during a press conference here Thursday. He had earlier in the day delivered the same message to Wall Street analysts during a conference call.

British health regulators on Wednesday lifted a five-month manufacturing suspension at Chiron’s Liverpool factory, where roughly half the United States’ 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 United States 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.

“When all critical stages of manufacturing are in full swing, and needed corrective actions can be fully evaluated, FDA plans to conduct a comprehensive inspection of Chiron’s Liverpool facility to assure that Chiron can produce a safe and effective vaccine,” the FDA’s Dr. Jesse Goodman said in a press release Wednesday. Goodman also said “work remains” before the FDA can approve Chiron’s manufacturing process.

Nonetheless, an upbeat Pien said he was optimistic Chiron could satisfy all FDA concerns and produce flu vaccine for next winter. Pien conceded that Chiron’s debacle this year opened the door for other companies to enter the U.S. flu vaccine market, which the company shared Sanofi-Aventis SA. Now, both GlaxoSmithKline PLC and ID Biomedical Corp. are working with the FDA to be able to sell their respective vaccines in the United States this year.

Pien declined to say what effect the new competition will have on Chiron sales.