Flu vaccine plant tainted in 2003
11/18/2004WASHINGTON - The Food and Drug Administration uncovered contamination and unsanitary conditions at a British flu vaccine manufacturing plant in 2003 but failed to reinspect it until similar problems caused the loss of half the U.S. vaccine supply in October, the top FDA official said yesterday.
FDA inspectors who visited the Chiron Corp. plant in Liverpool in June, 2003, found records of bacteria concentrations 1,000 times the expected level, said a report distributed by Democrats at a hearing of the House Government Reform Committee.
While not conceding the government made any major mistakes, the FDA's acting commissioner, Lester Crawford, said bacterial contamination was found in 2003 at the British plant that provides the United States with half its vaccine supplies. The plant, owned by the California-based firm Chiron, was shut down by the British government this autumn.
The House Government Reform Committee's hearings, chaired by Rep. Tom Davis (R., Va.), heard testimony that there is no certainty there will be enough vaccine next year either. If Chiron cannot produce vaccine next year, the nation will be hard-pressed to find enough for the 2005-2006 season as well, officials and doctors said.
Chiron's president and CEO, Howard Pien, testifying for the first time, apologized for his company's failure to provide vaccine for the current flu season. Mr. Pien said his company is putting new personnel in its Liverpool plant and spending $100 million to build a new facility to replace the old one. But he said whether it gets its license back and starts making producing new vaccines in March will depend on the U.S. and British governments.
Rep. Henry Waxman (D., Calif.), the ranking Democrat on the committee, said the FDA should have kept after Chiron to improve its practices and should have gone back to make sure the Liverpool plant had made improvements instead of waiting more than a year.
He said the FDA did not treat flu vaccine production as a crucial public-health issue.
Kathleen Coelingh, senior director of regulatory and scientific affairs for MedImmune Inc., a company that this year is making 3 million doses of FluMist, a nasal spray to prevent flu for those between the ages 4 and 49, said that private companies need tax incentives to do more research.
She said private companies do not want to take the risk of producing flu vaccine in the United States because making flu vaccines is an unpredictable business that is akin to making a new product every year. But she did not answer a question about what taxpayers would get in return for their investment except to say today's critical shortages could be avoided in the future.
The FDA's Mr. Crawford said his agency is trying to speed up licenses for new manufacturers to enter the field of vaccines, a process that normally takes years. The United States had 26 flu vaccine manufacturers 40 years ago but only has three today because it is considered a risky, unpredictable, and often unprofitable business.
The Centers of Disease Control and Prevention in Atlanta also is warning Americans to take extra precautions this year to avoid catching the flu, such as washing hands and having employers tell employees with flu to stay home.
The Associated Press contributed to this report.
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