Chiron says British flu vaccine plant passes test
Chiron Corp., which last year suspended U.S. sales of its flu vaccine because of contamination problems at its plant in England, on Wednesday said it hopes to supply the vaccine in the 2005-2006 flu season following a favorable inspection of the plant by U.S. regulators.
The U.S.-based company’s manufacturing license for its Fluvirin vaccine was withdrawn last October because of contamination problems at the factory in Liverpool, depriving the United States of almost half the nation’s anticipated flu vaccine supply.
The loss of the expected supply sent the U.S. government scouring the world for alternative supplies late last year.
Emeryville, California-based Chiron on Wednesday said the U.S. Food and Drug Administration has issued a favorable report about its nine-day inspection of the Liverpool plant in July.
Chiron said the FDA found Chiron’s responses and proposed actions to correct earlier quality-control problems at the plant “generally acceptable.”
“We remain focused on our objective of delivering Fluvirin vaccine to the U.S. market in support of public health efforts to prepare for the upcoming influenza season,” the company said in a statement.
Chiron’s reputation, and its share price, were battered by the forced shutdown of its plant last year and the company’s inability to deliver its injectable vaccine.
But British regulators in March gave Chiron permission to resume production of the vaccine for the coming winter’s flu season, as the company upgraded its equipment and manufacturing processes to better ensure purity of the product.
Chiron said it is hopeful that the company will be able to successfully produce and test the vaccine and that the FDA will give it the agency’s required approval for distribution in coming months.
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