None of Chiron Corp's flu vaccine made at a British plant is safe, which means the US flu vaccine supply will be half of what was expected, US health officials said on Friday.
Federal and state health officials worked to make sure that vaccines made by rival Aventis-Pasteur got to people who needed it most, such as the elderly and babies, while several states took action against price-gougers.
Long lines for shots were seen in some areas across the country.
Last week, British regulators suspended Chiron's license for the vaccine plant, throwing half the expected US influenza vaccine supply into doubt.
They and FDA inspectors have determined that Chiron's entire manufacturing process for the vaccine was unsafe and they have rejected all of the 48 million doses at the facility.
"All the lots produced by the plant are suspect at this point, and we cannot allow them to be used in the United States in the interest of public health," acting US Food and Drug Administration Commissioner Lester Crawford told reporters in a telephone briefing.
"The problems that we found in the plant in the U.K., in Liverpool, were what we call good manufacturing practice violations," he said.
Crawford said it appeared there was a problem in filling the vials for the vaccine.
Chiron said in a statement it was working to resolve the concerns raised by US and British regulators in order to resume manufacturing Fluvirin for the 2005/2006 flu season. "No doses of Fluvirin were released into any territory for the 2004/2005 flu season," said the company, based in Emeryville, California.
Chiron had found and reported contamination with a bacteria called Serratia but had hoped to correct the problem in time to save most of the vaccine production.
Crawford said whatever went wrong apparently affected everything Chiron made at the plant, which the California-based company acquired when it bought a British company called PowderJect.
Crawford said the FDA would certainly have found the problems, because even if Chiron had verbally reported it cleared them up, the FDA would have tested the vaccine before releasing it and would have found the contamination.
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