U.S. Eyes 5 Million Imported Flu Shots

Additional foreign vaccines would bring total to 66 million amid shortage

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HealthDay Reporter

THURSDAY, Oct. 28, 2004 (HealthDayNews) -- U.S. health officials announced Thursday that they have identified more than 5 million doses of flu vaccine from foreign sources that may be suitable for import to the United States.

If the government succeeds in securing them, that would bring the total to 63 million doses of injectable vaccine, along with 3 million doses of nasal vaccine. It still falls short of the 100 million doses the federal government had expected before British authorities shut down the manufacturing plant of a major supplier earlier this month, but "we're continuing to build our arsenal" for the upcoming season, Health and Human Services Secretary Tommy Thompson said.

"We are sending [U.S. Food and Drug Administration] inspectors to manufacturing facilities of GlaxoSmithKline in Germany and ID Biomedical in Canada to confirm the availability of vaccine," Thompson said at a news conference. "If they can ensure that the vaccine can be used safely, we will make arrangements to acquire it."

GlaxoSmithKline has about 4 million doses, and ID Biomedical about 1.2 million. The current major supplier, Aventis Pasteur, will be shipping 58 million injectable doses.

If all goes well, added Dr. Lester Crawford, acting commissioner of the U.S. Food and Drug Administration, vaccine would be available "in a few weeks, probably around the first of December at the earliest and no later than mid-December at the latest."

Asked whether the Administration's current intention to import flu vaccine conflicted with its long-standing opposition to importing prescription drugs from Canada, Thompson responded, "They're completely different. The FDA is assessing the safety of the flu vaccine. It can't do that with individual drugs."

Officials also announced a number of other initiatives intended to help soften the blow of this year's flu vaccine shortage. The shortfall was created Oct. 5, when the British counterpart to the FDA suspended the license of Chiron Corp. to manufacture 48 million doses at its plant outside Liverpool. The authorities cited ongoing problems with bacterial contamination of the vaccine.

About 200,000 doses of vaccine originally purchased for federal employees will be exchanged for 200,000 doses of FluMist, MedImmune Corp.'s nasal vaccine spray. The injectable vaccine will be used for high-risk individuals, while FluMist will go to healthy federal employees. In addition, about 100,000 doses from federal occupational health services will be redirected to high-priority individuals.

In addition, federal health advisors on Thursday reportedly expanded the use of FluMist to include children and teens between the ages of 5 and 18. Until this flu season and its current shortages, the nasal vaccine had only been recommended for healthy adults 18 to 50.

And Thompson announced that Merck & Co. plans to triple its production of pneumococcal vaccine, to between 17 and 18 million doses. "This vaccine helps prevent one of the major complications of flu [pneumonia]," Thompson said.

Also, state health commissioners and private industry will be able to share information on supply and demand of vaccines via a new secure Web site. "This will identify pockets of need, and that will be ratcheted in with future delivery," Thompson said.

Finally, Medicare has launched a program to reimburse beneficiaries who receive the shot from groceries, pharmacies and other providers, said Dr. Mark McClellan, administrator of the Centers for Medicare & Medicaid Services.

The federal government apparently also has plans to learn from the success of Illinois in locating extra flu vaccine. Gov. Rod Blagojevich announced two days ago that he had located more than 250,000 flu vaccinations from European suppliers and he asked FDA officials for swift approval so his state could take delivery.

"The governor is sending some of his staff in tomorrow with what information he has, and we're going to meet with them at the FDA," Crawford said. "We're going to find out what is going on and also make some interchanges about future steps. We're grateful for the information, and we'll receive it tomorrow."

The U.S. Centers for Disease Control and Prevention this week also announced that the life-or-death question of who should get this year's short supply of flu vaccine will be guided by a newly formed federal panel of ethicists.

The panel will make decisions about equitable distribution of the vaccine. One panel member told The New York Times that the group might ultimately have to tackle issues like whether babies should have priority over the elderly, or vice versa.

So far, however, this year's flu season is light compared to last year at this time and previous years, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. In the period covering Oct. 3-16, nine states and New York City reported "sporadic" flu activity, and 40 states reported none at all, according to the CDC publication Morbidity and Mortality Weekly Report. Eight confirmed cases were reported nationwide.

CDC director Dr. Julie Gerberding also said that, unlike last year, the current flu vaccine seems to be a good match to the viral strain most likely to affect Americans, the Associated Press reported. However, there is no scientific way to predict whether this flu season will be mild or severe, she cautioned.

More information

Find out more about the flu and the flu vaccine shortage at the U.S. Centers for Disease Control and Prevention.

SOURCES: Oct. 28, 2004, news conference with Tommy G. Thompson, U.S. Secretary of Health and Human Services; Lester Crawford, D.V.M., Ph.D., acting commissioner, U.S. Food and Drug Administration; Anthony Fauci, M.D., director, U.S. National Institute of Allergy and Infectious Diseases; Mark McClellan, M.D., Ph.D., administrator, U.S. Centers for Medicare & Medicaid Services; Oct. 28, 2004, The New York Times; Oct. 29, 2004, Morbidity and Mortality Weekly Report; Associated Press

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