Oct 15, 2004 (CIDRAP News) – Federal health officials today ruled out using any of Chiron Corporation's influenza vaccine in the United States this year, following the completion of inspections at the company's plant in Liverpool, England.
Shipment of Chiron's 48 million doses of vaccine was halted last week when the British government shut down the plant because of concerns about contamination. US officials had held out little hope that any of the Chiron vaccine could be used, and today's announcement confirmed the bad news.
"Today we're announcing that none of the flu vaccine made by Chiron for the US market is safe," Food and Drug Administration (FDA) Acting Commissioner Lester Crawford said at a news briefing late this afternoon. The announcement confirms the disappearance of nearly half of the previously projected US supply of 100 million doses.
Crawford said FDA officials who finished inspecting Chiron's Liverpool plant this afternoon found violations of "good manufacturing practices." "We did enough testing to conclude that we couldn't guarantee the safety of any of the vaccine," he said. "The contamination appears to be from the filling of the vials; that has to be done in a sterile way, and we're not sure that was the case." He said the contamination involved the bacterial species Serratia marcescens.
About a million doses of Chiron vaccine that had already been shipped to the United States probably can't be used either, Crawford said. "Our inclination and intention here is to test and retest those lots and see if some of it can be used. We are not optimistic about that and in fact do not believe it can be used," he said.
The Chiron disaster has left Aventis Pasteur as the only supplier of injectable vaccine for the US market. Aventis has produced 55.4 million doses, about 33 million of which have already been shipped to customers, according to the Centers for Disease Control and Prevention (CDC).
Because of the shortage, the CDC has recommended that healthy people forgo flu shots so the doses can be saved for people at high risk for flu complications, such as the elderly, infants, and people with chronic illness. The agency is working with Aventis to assure that the remaining doses go to those groups.
Crawford said the Department of Health and Human Services is hunting everywhere for more vaccine. "Literally every flu vaccine manufacturer in the world is being contacted, and some progress is being made," he said, without giving specifics.
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