(COMTEX) B: FDA 'would have' spotted flu shot problems ( United Press International )
WASHINGTON, Oct 22, 2004 (United Press International via COMTEX) -- The Food and Drug Administration said Thursday it "would have" inspected Chiron Corp.'s British vaccine plant and halted possibly contaminated flu vaccine -- even if British health officials had not pulled the plant's license Oct. 5.
The FDA told United Press International it got a safety report from Chiron Corp. that raised "serious concerns" about the company's own efforts to address contamination at its Liverpool flu vaccine plant this year.
In a statement, the FDA said a draft of that report was so troubling the agency would have inspected the plant. "In August Chiron made a commitment to send FDA an investigation report relating to the contamination issues it had identified," the agency said in its statement. "FDA expected to receive the report from Chiron the same week that the British authorities announced that it had suspended Chiron's license.
"The draft report FDA received from Chiron raised serious concerns about the quality and thoroughness of the firm's investigation. These concerns, coupled with the safety issues associated with the contaminated final product would have led to the same result, an FDA inspection of Chiron's facility."
The FDA cited that report in response to questions from United Press International about why the agency had not inspected that plant during 2004 --even though the last FDA inspection there in June 2003 showed high levels of bacteria in vaccine. UPI had asked the agency whether potentially contaminated vaccine might have made it into the U.S. market if British health authorities had not pulled the plant's license on Oct. 5.
The FDA said it routinely inspects vaccine plants every other year, and thus the plant was not due for inspection this year. The agency also said that after Chiron identified contamination in some flu vaccine in August 2004, the company agreed to send a report to FDA chronicling company efforts to investigate. An FDA chronology shows the agency asked for a draft of that report on Oct. 5, the same day British health officials pulled the plant's license.
After the FDA inspection that began Oct. 10, the agency said it could not rely on Chiron's assertions that the large majority of flu vaccine from the plant was safe.
"FDA's inspection found significant deficiencies in quality control and concerns regarding the test results," the FDA said in a statement Oct. 16. "Although Chiron's retesting of the unaffected lots of vaccine has been negative for contamination, FDA has determined that it cannot adequately assure the sterility of these lots to our safety standards."
Chiron spokeswoman Alison Marquiss said the company is working to fix any problems in Liverpool. "We are continuing to work with regulatory authorities in the U.S. and the U.K. to implement a solution to bring our facility back on line as quickly as possible," she said. Health officials in both countries "have identified processes that need to be addressed and we are cooperating fully with those agencies. We appreciate the guidance from both agencies."
A vaccine safety advocate said the close call shows the need to improve vaccine safety protocol.
"There should be no higher standard than ensuring the safety and efficacy of our vaccines," said Barbara Loe Fisher, president of the National Vaccine Information Center, which does not take money from vaccine manufacturers. "We better thank the Good Lord that this time they caught the contamination before it was too late. If the regulatory system had broken down enough, that vaccine could have caused some serious health problems and maybe death."
The June 2003 FDA inspection found high levels of contamination in vaccine at a relatively early phase in the production process. Agency officials said reports from the company in 2003 showed Chiron addressed those issues.
In August 2004, Chiron announced that a "small number" of flu vaccine lots "do not meet product sterility specifications" but the company still expected to get 50 million doses to the United States.
The loss of that vaccine has led to long lines for senior citizens around the country hoping to get shots.
By MARK BENJAMIN
Copyright 2004 by United Press International.
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