German flu vaccine being tested

U.S. may purchase up to 4 million doses as licensing study begins at 4 sites

Science & Research

December 10, 2004|By Erika Niedowski | Erika Niedowski,Sun Staff

The University of Maryland School of Medicine is one of four institutions nationwide studying the safety of a foreign-made influenza vaccine to determine whether it can be licensed in the United States in time for next year's flu season.

Beginning Monday, the school's Center for Vaccine Development will immunize 250 healthy people with a vaccine manufactured in Germany by the British pharmaceutical company GlaxoSmithKline. The test product, Glaxo's Fluarix vaccine, has been used by an estimated 126 million people in more than 70 countries, including Great Britain and Australia, and is widely considered safe and effective.

U.S. health officials announced this week that they are purchasing 1.2 million doses of Fluarix under an investigational license to supplement this year's limited vaccine supply. The government may buy 2.8 million more from Glaxo, depending on the severity of the flu season.

"The vaccine is made in a nearly identical fashion to the vaccine made that is licensed in the United States," said Dr. Jim Campbell, assistant professor of pediatrics at Maryland's School of Medicine and the lead investigator of the study. "This data plus the worldwide, decade-long or more experience -- all that together -- we expect to lead to licensure for next year's season."

Researchers at the University of Rochester, Cincinnati Children's Hospital and Baylor University are also participating in the trial. About 1,000 patients, ages 18 to 64, will be enrolled nationwide.

The current vaccine shortage came as no surprise to many in the public health sector; the government, after all, had been relying on just two manufacturers -- Chiron Corp. and Aventis-Pasteur -- for all of its injectable doses.

In October, the British equivalent of the U.S. Food and Drug Administration temporarily suspended the manufacturing license of California-based Chiron, which has a vaccine production plant in Liverpool, England, citing contamination problems there.

This week, Chiron's difficulties seemed to deepen when British health officials extended the plant shutdown at least until April. The move raised further concerns over the company's ability to provide vaccine doses for the American market by the start of next year's influenza season.

Either way, U.S. health officials have been scrambling to line up new vaccine providers -- not just to meet the current demand but to address future needs as well.

ID Biomedical, a Canadian pharmaceutical company, hopes to have its influenza vaccine, Fluviral, licensed for use here by 2007. U.S. Health and Human Services Secretary Tommy Thompson has said that another firm, which he did not name, may also enter the flu vaccine market as early as next year.

"The more producers, I think, the better off [you are]," said Campbell, "because then you can absorb the loss of one if there's an issue like there was this year."

The flu vaccine shortage has not turned into a major public health crisis so far this season. The Centers for Disease Control and Prevention in Atlanta reported low overall flu activity across the nation for the week ending Nov. 27. Thirty-six states, including Maryland, and the District of Columbia had reported sporadic cases of the virus.

Six influenza cases had been laboratory-confirmed in Maryland as of Saturday, said Karen Black, spokeswoman for the state Department of Health and Mental Hygiene.

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