FDA Denies Knowing Extent of Flu Vaccine Production Problems

MONDAY, Oct. 11, 2004 (HealthDayNews) -- U.S. health officials Monday denied reports that they knew before last week that there were major production problems with a key American manufacturer's flu vaccine, which caused British authorities to suspend the company's license.

"The most recent inspections did not give any indication that Chiron [Corp.] would not be able to fulfill its recent public promise," Dr. Lester Crawford, acting commissioner of the U.S. Food and Drug Administration, said at a news conference.

Chiron, a California-based biotech company, was under contract to provide as many as 48 million doses of flu vaccine to the United States, nearly half of the supply. But the company lost its license and all its shipments were halted Oct. 5 after British health officials found contamination problems at the company's U.K. plant outside Liverpool.

On Monday, however, USA Today reported that U.S. health regulators had identified problems at the British plant more than a year ago, in June 2003.

Crawford acknowledged that the FDA had, in fact, found higher-than-expected levels of bacteria at the Chiron plant at that time. But it was during an early stage of manufacturing and the contamination did not persist into later stages of the production process, he said.

"The contamination identified by Chiron this year was different from last year," Crawford said. "Shortly after the 2003 inspection, we felt that everything had been reconciled, and we do not believe the situation found in 2003 relates to this particular problem."

The FDA became aware of the recent problems Aug. 25, Crawford said, but had no idea they were serious enough to warrant drastic action by the British government.

FDA and Chiron officials were in weekly contact regarding conditions at the Liverpool plant, and "no one at FDA was notified by Chiron of any increased level of concern regarding the company's investigation into bacterial contamination," Crawford said. "Chiron said the investigation was nearly complete, and the re-testing of lots which were initially negative were still shown to be negative."

While the FDA was communicating regularly with Chiron, it did not appear to be communicating with British authorities.

"It was our expectation, based on our communication with Chiron, that the problem would be cleared up. And we also knew the problem was in a minority of lots, so it would be unusual to call British authorities about this specific problem," Crawford said. "We did not expect they would take this strong an action at any point."

Chiron "seemed to be making progress," Crawford added. "We were scheduled to have our final conference call with Chiron on the same day (Oct. 5) that England announced the closing of the plant."

While there may not have been any open clash between the U.S. and U.K. health regulators, this incident does point up some unresolved issues in their relationship.

"I wouldn't say there's a conflict here, but the two laws [that govern each nation's production of vaccines] do not recognize each other," Crawford said.

Crawford also said, "We don't have any reason to believe that they were incorrect, but we were doing our own study and investigation."

As the number of companies supplying flu vaccine to the world dwindles, future conflicts may become more pronounced.

"This is going to call for better communication," Crawford said. "We need to use this as a test case, because if the contraction of the industry continues, there are going to be even fewer companies manufacturing vaccine over the next few years -- and they will become international resources, not just national resources. I believe we need to clarify the rights and privileges of a country that is importing a vaccine from a given country with respect to its production and regulation. It might be a job for the World Health Organization or the European Medicines Evaluation Agency. We intend to pursue that."

Although Aventis Pasteur will be producing 55 million doses for the United States this flu season, the pending vaccine shortage has prompted the U.S. Centers for Disease Control and Prevention to urge that all hospitals and other health-care providers give flu-shot priority to high-risk individuals, including the elderly and small children.

For those not at risk, federal health officials are recommending frequent hand-washing to protect against the flu. They are also recommending that people eat a balanced diet and get plenty of rest during the flu season, which can start as early as October and last as late as May.

More information

For more on the flu and flu vaccine, visit the Centers for Disease Control and Prevention.