NEW YORK (CNN/Money) -
Drug manufacturer Chiron Corp. was preparing to announce it wouldn't release any flu vaccine to the United States a week before British health regulators forced it to pull the vaccine from the market due to contamination concerns, and ahead of a statement from the company that it would deliver the flu shots on time, according to a published report.
The Wall Street Journal reported Wednesday it had reviewed a draft press release dated Sept. 27 that said the company's "internal quality-assurance confirmatory testing" of its Fluvirin vaccine had "failed to provide results necessary to permit release of the vaccine to the market."
Instead on Sept. 28 the company released a statement saying it intended to ship the flu vaccines on time. A week later on Oct. 5 the company announced it would not be able to deliver 46 million to 48 million vaccines, about half the expected U.S. supply for the upcoming flu season. It also warned at that time of a better than $200 million hit to its earnings due to problems with its vaccine.
Chiron spokeswoman Alison Marquiss told the Journal that the draft release was prepared as a "contingency" and that company officials were simply readying themselves for any potential scenario. Marquiss said the actual Sept. 28 release "matched our test results," which appeared to show that Chiron had fixed the contamination problems.
Chiron officials said when the vaccine was pulled that they were "surprised" by the decision of British health regulators to pull the product made at the company's Liverpool, England, plant. But the Journal reported in late August that Chiron discovered some contaminated lots of flu vaccine from the plant, prompting it to retest its vaccine supplies.
The newspaper also said the plant, acquired by Chiron in 2003 when it purchased British vaccine maker PowderJect Pharmaceuticals PLC, appears to have had a history of problems. The Food and Drug Administration documented some shortcomings after a visit in June 2003, it said.
Chiron Corp. announced last week that the Securities and Exchange Commission (SEC) has launched an informal inquiry into the company's handling of the news about problems with its flu vaccine. It also said it has received a federal grand jury subpoena about the problems.
The company is set to release its third-quarter earnings after the market close Wednesday. After the company's warning the day the flu shot withdrawal was announced, analysts surveyed by earnings tracker First Call cut their earnings per share forecasts to 6 cents a share, down from 60 cents a year earlier. Analysts had been looking for EPS to rise to 75 cents before the vaccine problem was revealed.
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