WASHINGTON - A Food and Drug Administration report made public yesterday shows that bacterial contamination at Chiron Corp.'s flu vaccine plant in England is more widespread than previously thought, raising doubts about the company's ability to deliver flu shots in 2005.
Also yesterday, the FDA disclosed during a congressional hearing into the vaccine shortage that the results of an inspection of the plant in June 2003, which found evidence of contamination and faulty sterilization procedures, were not shared with the company until a year later, when it would have been too late to make changes to salvage this year's batch of 50 million shots.
British health regulators shut down the Chiron plant Oct. 5 after determining that the purity of its Fluviran vaccine could not be guaranteed, eliminating almost half of this country's expected supply for the current flu season.
The FDA's follow-up inspection of the Liverpool factory last month found 60 percent of the sampled vaccine was contaminated, with several types of bacteria and at many sites, including after the sterilization stage.
The level of contamination appears to be several thousand times acceptable levels, according to people who reviewed the report.
"These problems should have been corrected, and they were not," said Deb Chakravarti, a professor at the Keck Graduate Institute of Applied Life Sciences. "This is very serious."
"It is much worse than I thought," said Geoffrey Porges, an analyst with Sanford C. Bernstein. "It is an antiquated facility and poorly managed. They are going to have to make material improvements."
Porges said the odds of Chiron getting the plant in shape for the 2005 flu season were less than 50-50.
The two inspection reports released by the FDA stirred charges on Capitol Hill yesterday that the agency was too timid in its oversight of the plant and so lost an opportunity to demand improvements that might have headed off this year's shortage.
After its 2003 inspection, the FDA chose to work cooperatively with the British factory rather than to threaten enforcement action, as had been recommended by the agency's own inspectors.
"The documents show that FDA failed to provide effective oversight," said Rep. Henry Waxman of California, the ranking Democrat on the House Government Affairs Committee, during a hearing. He said that if the agency had moved more aggressively after 2003 "the problems at the plant might have been avoided."
Dr. Lester M. Crawford, acting commissioner of the FDA, defended his agency's handling of the matter. He told the panel that the factory's procedures were improving in 2003 compared with earlier years and that seeking Chiron's cooperation, rather than threatening the company with enforcement action, was entirely appropriate.
"They in fact completed what we wanted them to do," he said. "There was no need for a warning letter. They corrected the problem. We got the vaccine produced, and it was OK."
The one error Crawford acknowledged was the time it took FDA to provide Chiron with the summary of its inspection findings from June 2003. "We've corrected that procedure, but that was a mistake," he said.
Howard Pien, chief executive of Chiron, told the committee yesterday that the company was making every effort to solve the factory problems so it could be cleared to produce flu vaccine next year.
The FDA inspection report from last month documents sloppy techniques and quality control at critical points in the manufacturing process.
Flu vaccine consists of three strains of virus, grown in separate groups of chicken eggs. The viruses are separated from the eggs, killed and filtered into batches containing a single virus strain. Then the batches are blended and sterilized to form vaccine. In the final step, the vaccine is put into vials.
Because the vaccine is made from eggs, some level of contamination is expected in the early stages of production. However, the FDA report found unusually high levels early in the process, a situation that seemed to get worse as production continued.
Chiron sent contaminated batches of unblended vaccine through the production process even through the bacterial levels in the vaccine exceed accepted levels "by several orders of magnitude," the report said.
FDA inspectors found bacteria in the filling room, where vaccine is placed into vials, which is supposed to be sterile.
Chiron tried to control the contamination last spring and inaccurately deemed its efforts a success, the FDA report said.
In many cases, according to the report, Chiron didn't even know what sort of bacteria it was dealing with. The FDA said 80 percent of the microorganisms growing in key parts of the factory - the filling room, the filtration area and the formulation suite - had not been fully identified.
The FDA also said Chiron didn't conduct regular maintenance and lacked written instructions for cleaning tanks, centrifuges and other equipment used to make vaccine.
"It goes to the general sloppiness of the whole thing," said Chakravarti of the Keck Graduate Institute.
The Los Angeles Times is a Tribune Publishing newspaper.