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U.S. Searching Out More Flu Vaccine Worldwide

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Reuters Health

By Susan Heavey and Lisa Richwine

Thursday, October 14, 2004

WASHINGTON (Reuters) - U.S. health officials are talking with several flu vaccine producers worldwide in hopes of securing doses to protect millions left vulnerable when manufacturing problems cost the country half its supply.

"I'm working very hard on that," Health and Human Services Secretary Tommy Thompson told reporters on Thursday, but added "it doesn't look promising, but we're looking."

If companies were willing to provide doses, they would need regulatory approval to sell in the United States, he said. Thompson would not speculate on how long that would take.

Britain suspended Chiron Corp.'s license to ship influenza vaccine from its Liverpool, England, plant, this month saying it had found systemic problems that led to some bacterial contamination.

The British decision could mean the destruction of 48 million doses of vaccine, out of 100 million doses destined for the U.S. market from Chiron and Aventis-Pasteur. Another 2 million doses will be available from MedImmune, which makes a nasal vaccine called FluMist for healthy adults.

Thompson said he was receiving daily briefings about a Food and Drug Administration inspectors' visit to Chiron's Liverpool plant. He declined comment about their findings until a final report is completed, hopefully next week.

Flu vaccine takes months to make, which has left U.S. officials scrambling for doses for the current flu season.

U.S. President George W. Bush said during Wednesday's presidential debate that administration was working with Canada to obtain more vaccine. Bush has opposed importing drugs from Canada, citing safety fears.

To help avoid future shortfalls, Thompson called for more liability protection for vaccine makers and a switch from egg-produced flu vaccine to a product made with cell cultures, something currently being studied.

Health agencies, including HHS and the Centers for Disease Control and Prevention, have been asking for more authority for years over vaccines, warning that the current system was fragile because so many companies have left the market.

Drug companies complain vaccines are expensive to make and regulated heavily and say the market is uncertain. In a typical year millions of doses of flu vaccine are discarded because no one uses them.

The attorney general of Kansas filed suit against Meds-Stat this week, charging the Florida-based drug distributor with price gouging.

Thompson said the agency has contacted state authorities, attorneys general and others about inflated prices.

Meds-Stat said the allegations were untrue and it would vigorously defend itself in court.



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