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Millions sought to upgrade flu vaccine production

High demand from the public means vaccine shortages this flu season.
High demand from the public means vaccine shortages this flu season.

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(CNN) -- Federal health officials will seek $150 million from Congress over the next two years to encourage flu vaccine makers to adopt new manufacturing processes that could speed up production to respond to outbreaks, Health and Human Services Secretary Tommy Thompson said Tuesday.

Thompson also said officials are hopeful that this year's flu outbreak has peaked, though it remains unclear if it will move from hard-hit western states into the East.

"We're hoping we've got the worst behind us because it started early," he said at a news conference. "But we don't know."

To deal with problems with the vaccine supply, Thompson said, his department has a request for $50 million in a fiscal year 2004 appropriations bill now before Congress and will seek another $100 million in fiscal year 2005.

He said the current flu season, which has severely stretched supplies, may encourage lawmakers to act.

"I think Congress is going to be much more willing to appropriate the necessary dollars to get into the new technologies," he said. "Hopefully, it will survive the budgetary process."

Because flu viruses mutate from year to year, the vaccine cannot be stockpiled, and manufacturers cannot respond to outbreaks by ramping up vaccine production because the outbreak would be over by the time more vaccine is ready.

But Thompson said producing vaccine with new technologies, using cell cultures instead of eggs, could streamline the process, allowing manufacturers to respond quickly if a flu epidemic or pandemic occurs.

However, federal health officials cautioned that it might take several years before the new methods could be used, because they still have to be tested and approved by the Food and Drug Administration.

Because of the time frame for production, vaccine manufacturers also have to estimate, before the flu season begins, how many doses of vaccine to make. Last year they made 95 million doses, but because they ended up throwing away 12 million doses, they cut production for this year to about 87 million doses, Thompson said.

But an early flu season this year, with major outbreaks in at least 24 states, has strained vaccine supplies, forcing the federal government to import vaccine from overseas.

Extra doses purchased

On Monday, the government announced it had bought an extra 375,000 doses of flu vaccine.

"With this purchase, HHS has acquired remaining stock from both of the manufacturers who produced injectable vaccine for the United States this year," Thompson said. "These doses are part of the stock that was developed for the U.S., licensed and approved for use by the Food and Drug Administration."

The doses of flu vaccine were purchased from Chiron, of Emeryville, California, at $7.40 per inoculation, said Curtis Allen, a spokesman for the Centers for Disease Control and Prevention.

The doses will be added to the 250,000 doses Thompson announced last week that HHS bought from Aventis-Pasteur of Bridgewater, New Jersey, the nation's other manufacturer of injectable flu vaccine.

Asked about the Chiron product, CDC Director Dr. Julie Gerberding told reporters that it was licensed in Britain and would require sterility testing, "and a series of other regulatory issues" before it could be used in the United States.

Those issues mean that the Chiron vaccine, which is in bulk form and will have to be broken into individual doses before being released, will not be available until January, said HHS spokesman Bill Pierce.

Once the safety checks are completed, the vaccine will be sold to states based on "an allocation system designed to ensure equitable distribution," HHS said in a written statement.

In addition, HHS announced that it has negotiated a $20-per-dose price for up to 3 million doses of FluMist, an inhalable form of flu vaccine that is approved only for healthy people ages 5 to 49.

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