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British Flu Vaccine Is Unusable, FDA Says

Factory Inspection Finds None Is Safe

By Rob Stein
Washington Post Staff Writer
Saturday, October 16, 2004; Page A10

A last-ditch U.S. inspection of a British vaccine factory that officials hoped might salvage millions of desperately needed flu shots concluded yesterday that none can be used safely, dashing lingering hopes of averting an influenza inoculation crisis as the winter approaches.

A team of Food and Drug Administration inspectors determined there was no way to ensure that the system Chiron Corp. used for filling vials at its Liverpool plant would have prevented contamination with a dangerous bacteria detected at the plant in August, officials said.

_____Flu News_____
No Evidence Flu Vaccine Works in Kids, Study Finds (Reuters, Feb 25, 2005)
Flu Season Arrives, Late but Potent (The Washington Post, Feb 11, 2005)
Health Groups Now Worry About Flu Shot Surplus (The Washington Post, Jan 28, 2005)
Flu Special Report

"Today we are announcing that none of the influenza vaccine manufactured by the Chiron Corporation for the U.S. market is safe for use," said Lester M. Crawford, FDA's acting commissioner, in a hastily arranged late-afternoon briefing. "We dispatched a team . . . to see if there was any possibility of salvaging any of the vaccine for this year, and we unfortunately wound up reaching our final conclusion this afternoon that none of it could be used."

The announcement was another blow to U.S. health officials, who are scrambling to calm growing public alarm about vaccine shortages because of the loss of about half of the 100 million doses of flu vaccine the nation was expecting. Long lines of anxious people, mostly elderly, have begun showing up across the country as people scramble for the remaining vaccine. One elderly woman fell and died in California this week after waiting for hours outside a clinic.

Health officials announced that the only remaining supplier of vaccine in the United States, Aventis Pasteur Inc., this week had shipped 2 million doses to veterans' hospitals, nursing homes, pediatricians and state and local clinics as part of a frantic effort by the federal government to make sure the remaining vaccine stocks get to those who most need it as quickly as possible.

"This shortage is frightening to people, and they're rushing out and standing in long lines thinking they need the vaccine right now before it's all gone. We want them to know more is coming," said Julie L. Gerberding, director of the Centers for Disease Control and Prevention. "It's not outbreak time yet. . . . We are not in a situation where it's an emergency for people to run out and get vaccinated. There's still time to get it and be protected."

In addition, the government is stockpiling antiviral drugs and working with manufacturers to increase production so medicine will be available to help stanch outbreaks this winter, Gerberding said.

"This is a very important component of protecting people from flu if they can't take the vaccine or get the vaccine and they need it," Gerberding said.

U.S. officials were stunned last week when British authorities announced they were shutting down Chiron's plant, which was supposed to supply the United States with 48 million doses of vaccine.

The FDA dispatched a team of inspectors to confirm the British determination that the company had failed to correct problems that had led to the contamination detected in nine lots of vaccine in August. Despite the company's assurances that the problems had been corrected, FDA inspectors concluded that could not be assured.

"We believe that all of the lots produced by that plant are suspect at this point. So we cannot allow them to be used in the United States, in the interest of public health," Crawford said.

The FDA plans to test Chiron vaccine that had been shipped to the United States before the British announcement -- all of which was placed in quarantine -- in one final attempt to see whether any could be used.

"We do not want to create false hope, but we want to explore every option," Crawford said, adding he was doubtful any would be usable. "We are not optimistic about that and, in fact, do not believe any of it can be used."

In the meantime, federal officials were scouring the world for any other stocks that could be diverted to the United States.

"Every known manufacturer of flu vaccine in the world is being contacted, and some progress is being made," Crawford said.

© 2004 The Washington Post Company


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