Company's flu vaccines can't be salvaged, FDA chief says

All doses from factory in England are unsafe, health officials confirm

October 16, 2004|By Erika Niedowski | Erika Niedowski,SUN STAFF

After an "exhaustive" inspection of the plant where it was produced, the head of the U.S. Food and Drug Administration declared yesterday that none of the flu vaccine made by Chiron Corp. is safe for use in the United States.

Lester M. Crawford said that all of the Chiron-produced doses - up to 48 million originally destined for the U.S. market - are considered "suspect" after random testing found contamination in batches that the company had insisted were pure.

The acting FDA commissioner did not say how many of the 100 inspected batches were found to be tainted.

"We did enough testing to conclude that we couldn't guarantee the safety of any of the vaccine, and that's the only relevant conclusion," he said in a late afternoon conference call with reporters.

The FDA findings essentially confirm those of British officials, who last week suspended Chiron's manufacturing license for three months because of production problems at the Liverpool plant where the vaccine is made. The announcement also dashed any hope that some of the vaccine could be salvaged to address what has become a critical national shortage.

California-based Chiron announced in August that several of its Fluvirin vaccine lots were found to be contaminated. But the company repeatedly told U.S. health officials that it expected to resolve the problem in time to provide vaccine for this year's flu season.

Last week, after British regulators yanked the company's manufacturing license and blocked it from shipping vaccine, Chiron President and Chief Executive Howard Pien called the decision "disappointing" and "unexpected." He insisted that the bacterial contamination - which he attributed to human handling error - was confined to a small number of batches.

At the time, U.S. health officials said they too were disappointed in the action of the British Medicines and Healthcare Products Regulatory Agency - the British equivalent of the FDA - on the very cusp of flu season. But the team of FDA inspectors dispatched to Britain to inspect Chiron's plant for themselves found cause for the suspension.

The problems they discovered, Crawford said, "were what we call `good manufacturing practice' violations."

"The system was such that a small number of the lots were in fact contaminated, and as we tried to assure ourselves that this was isolated to those few lots, we were unable to do so based on the records and the testing," he said. "We cannot allow them to be used in the United States in the interest of public health."

Crawford confirmed that the contaminant was the serratia bacteria and said the problem probably occurred during the final step of the production process - the filling of vaccine vials.

He said the FDA was scheduled to receive a production report from Chiron the same day British regulators acted, and he insisted that the U.S. agency would have caught the problems itself.

A representative for Chiron could not be reached for comment last night. The company announced in a one-sentence statement yesterday that Richard Wills, a member of its board of directors, had resigned.

Though Chiron had shipped some vaccine doses to the United States before last week, none of them have or will be used, federal officials said yesterday.

"The vaccine that people are receiving this year is all produced by Aventis," said Dr. Julie L. Gerberding, director of the federal Centers for Disease Control and Prevention. "The only exception to that [is] the people who are taking the nasal vaccine" produced by MedImmune of Columbia.

Of the 55.4 million vaccine doses being provided by Aventis Pasteur, about 22.4 million hadn't been shipped by last week. Under a plan worked out with the CDC, the company is redistributing doses directly to the places that need them most: pediatricians' offices, nursing homes, state health departments and acute-care hospitals. Two million doses were shipped this week, Gerberding said.

"I think the bottom line is: We realize that the supply is coming. It's not coming as fast as we would like," she said. "We are doing everything we can to help move it along in an orderly fashion. The operational words are persistent and patient at this point in time."

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