Wednesday, October 13, 2004

Health officials yesterday said 22.4 million unshipped doses of flu vaccine will be made available to people who are most at risk of getting the virus.

The U.S. Centers for Disease Control and Prevention (CDC) is scrambling to make up for the loss of nearly half of the nation’s flu vaccine, a shortage created last week when British officials suspended Chiron Corp.’s license to sell vaccine made at its Liverpool facility.

The CDC negotiated a plan with Aventis-Pasteur, the French company making 55.4 million doses of vaccine for U.S. distribution, to get the undelivered 22.4 million doses to children and the elderly.



The goal is to get that vaccine to those who need it most, CDC Director Dr. Julie Gerberding said.

“We will take every step that we can take to get an equitable distribution of vaccine as quickly as we can,” she said.

More than half of the 55.4 million doses already has been sold and shipped, mostly to private distributors, and can’t be yanked back, although Aventis is asking customers to share any not reserved for high-risk patients.

Under the plan announced yesterday, Aventis-Pasteur will ship the remaining 22.4 million doses in at least two stages. In a first wave of distribution, the CDC and Aventis-Pasteur will allocate about 14.2 million doses over the next six to eight weeks to hospitals, long-term-care facilities, homes for the elderly and private health-care providers for children.

The military and state health departments that relied on vaccine from Chiron also will be given priority.

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But millions of people won’t get a shot this year to protect them from influenza, which kills an average of 36,000 Americans each year. About 83 million people were vaccinated last year, and the CDC had hoped that 100 million people would get a flu shot this year.

But Chiron, which would have supplied up to 48 million doses, discovered a bacteria in its vaccine.

“We’re sorry for the people who need flu vaccine and may not be able to get it this year,” Dr. Gerberding said.

Now the CDC hopes to get vaccine to the 42 million to 50 million people who it considers at risk. That group comprises children 6 to 23 months; adults older than 65; people 2 to 64 years old with chronic health problems; pregnant women; nursing-home residents; health care workers; and people who work with children younger than 6 months.

The remaining 8.2 million doses of vaccine produced by Aventis-Pasteur won’t be distributed until it becomes clearer which areas of the country need more vaccine, and that will depend in part on which regions are hit hard by the flu.

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Dr. Gerberding said regions across the country are without vaccine or dealing with a shortage.

“We want to focus on identifying the gaps,” she said.

Health officials hope to know by the end the week where Chiron planned to ship vaccine. They will compare that with a list showing where Aventis-Pasteur has shipped vaccine.

Health officials also plan to share information electronically with pharmacies, doctors, the Department of Veterans Affairs and others throughout the country to track the progress of the flu virus to identify which counties have a flu outbreak and whether those areas need more vaccine than they have available.

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Also yesterday, Chiron said it is under investigation by the Justice Department. The U.S. Attorney’s Office for the Southern District of New York is seeking “documents and materials” related to the British suspension of Chiron’s manufacturing license, the company said in a U.S. Securities and Exchange Commission filing.

Two companies have offered to help U.S. health officials by providing vaccine intended for sale in other countries.

GlaxoSmithKline has 500,000 doses that it made in Germany, and ID Biomedical Corp. has 1 million to 1.5 million doses that it made in Canada. The Food and Drug Administration hasn’t approved either company’s vaccine for sale here.

Dr. Gerberding called “heroes” those healthy adults heeding CDC’s plea to forgo flu shots this year. But, “shame on the people who are price-gouging,” she said, pledging to help state officials prosecute those caught doing so.

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There have been scattered reports of price-gouging since the shortage was announced, and Kansas filed a lawsuit yesterday against Meds-Stat, a pharmaceutical distributor.

Attorney General Phill Kline said Meds-Stat proposed selling the vaccine to a pharmacy in Kansas City, Kan., on Friday for $900 per vial; a week earlier, the company was selling the vaccine for $85 per vial. Each vial contains about 10 doses.

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