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Chiron vaccine on hold, not safe, FDA says

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Washington --- None of the nearly 50 million doses of Chiron Corp. flu vaccine being held in a plant in England are safe, the Food and Drug Administration announced Friday.

That closed off any lingering hope that the United States would have anywhere near the 100 million doses of vaccine that experts had said it would need to properly immunize the population from this year's anticipated flu outbreaks. An estimated 36,000 Americans die of influenza during a typical flu season.

Acting FDA Commissioner Lester Crawford said tests of the Chiron vaccine found further evidence of the bacterial contamination that was first uncovered in August and that an audit confirmed safety violations in the company's operation.

He added that the government was scouring ''literally every known manufacturer of flu vaccine in the world'' in search of replacement doses.

Crawford said that U.S. and British officials agreed Friday to provide Chiron with technical assistance to correct whatever problems exist in the plant in order to ''get it up and running'' in time to produce vaccine for next year's flu season.

He said several million doses of vaccine that Chiron had shipped from the plant to the United States before contamination was discovered are still being tested for safety.

Centers for Disease Control and Prevention Director Julie Gerberding said Friday that no doses of flu vaccine given to Americans so far have come from Chiron.

The CDC has organized an effort get more than 50 million doses of injectable vaccine produced by Aventis Pasteur distributed among the elderly, very young children and others with health conditions that cause them to need it most.

She said that early flu outbreaks in the Southern Hemisphere appear to be primarily caused by viral strains against which current vaccine formulations are effective.

In other developments, leaders of a House committee that has investigated the government's handling of the flu emergency asked the Federal Trade Commission to investigate reports of flu vaccine price gouging. The attorneys general of several states have either opened investigations or warned that they would prosecute gougers.

Reps. Tom Davis (R-Va.) and Henry Waxman (D-Calif.) asked FTC Chairwoman Deborah Platt Majoras to tell them what the agency was doing about gouging by wholesalers and distributors who "are taking advantage of public fears."

An FTC spokeswoman would not say whether any investigation was planned but said the agency was working Friday on a response to Davis and Waxman, chairman and ranking Democrat, on the House Government Reform Committee.

The FDA's Crawford said Friday that the vaccine contamination appeared to take place as sterile vials were being filled and that some vaccine appeared to be contaminated ''in bulk lots'' before the vial-filling step.

Problems at the plant came to light Aug. 25 when Emeryville, Calif.-based Chiron informed the FDA and the British Medicines and Healthcare products Regulatory Agency of some contamination. British authorities then visited the plant in mid-September, finding the separate but related failure of Chiron to follow practices designed to prevent contamination. It is unclear if FDA officials were aware of those inspections and results.

The British agency on Oct. 5 suspended Chiron's license for three months. The company immediately announced it would not ship any more vaccine this year and would concentrate on getting the plant into compliance to produce vaccine next year.

Crawford, who last week said he was ''shocked'' by the British finding, said Friday that FDA officials had been scheduled to review data from Chiron on Oct. 5. He said he believed this information would have revealed to FDA officials the same problems the British had found.

Copyright 2004 The Atlanta Journal-Constitution

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