- The Washington Times - Sunday, October 10, 2004

When British authorities shut down Chiron Corp.’s manufacturing facility last week, it reaffirmed Tony Holler’s belief that there is room for another supplier of flu vaccine.

Mr. Holler’s firm, ID Biomedical Corp. in Vancouver, British Columbia, plans to begin selling vaccine in the United States by the 2007 flu season.

“Our reason for getting into the market is that it’s underserved. But [Chiron’s suspension] confirms that the U.S. is at risk because there are only two producers of the vaccine,” said Mr. Holler, chief executive of ID Biomedical.

Last week’s announcement that the nation’s supply of flu vaccine will be cut nearly in half has shed light on the fragility of the supply and has health officials calling for change.

“This shortage is a call to action,” Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, told reporters Friday after a hearing of the House Government Reform Committee, which is investigating the flu vaccine shortage.

A few companies have plans to make flu vaccine for U.S. distribution, giving public health officials the shot in the arm they need.

ID Biomedical is expanding a facility in Quebec to accommodate annual production of 50 million doses of flu vaccine. The company provides flu vaccine for 75 percent of the Canadian market, or 10 million doses.

If ID Biomedical earns regulatory approval to sell flu vaccine in the United States, it would be the third company distributing an injectable flu vaccine for use here.

Baxter International Inc. of Deerfield, Ill., also plans to enter the U.S. flu vaccine market. Baxter, which sells the vaccine in Europe, doesn’t expect to complete clinical trials and earn U.S. regulatory approval until about 2007.

“I think it’s fair to say that we’re at least a few years away in the U.S.,” Baxter spokeswoman Deborah Spak said.

GlaxoSmithKline and Solvay Pharmaceuticals Inc., which also market flu vaccine in Europe, plan to seek regulatory approval to market flu vaccine in the United States.

It is not clear how quickly either company will enter the market.

If those four companies distribute flu vaccine in the United States, it could help reverse a trend that contributed to the shortage. The number of U.S. companies that produce vaccine has decreased from about 20 in 1980 to five today.

Flu vaccine in the United States comes from three companies: Chiron and Aventis-Pasteur, which produce injectable vaccines, and MedImmune Inc. in Gaithersburg, which makes FluMist nasal spray.

Drug maker Wyeth got out of the business in November 2002 to focus on production of Prevnar, a widely distributed vaccine for meningitis, and other drugs. Eli Lilly and Co. stopped making flu vaccine in 1974 to concentrate on production of pharmaceuticals.

“A vaccine is used once, at best,” Eli Lilly spokesman Ed Sagebiel said, while prescriptions for pharmaceuticals to treat chronic conditions like diabetes or depression are filled multiple times.

Health officials are suggesting federal government incentives, such as guaranteeing the purchase of a fixed number of doses. That would allow health officials to create a stockpile of flu vaccine, said Bruce Gellin, head of the National Vaccine Program Office at the Department of Health and Human Services.

It also would address manufacturers’ concern about steady demand, Christine Grant, vice president for government affairs at Aventis-Pasteur, said at Friday’s hearing.

Health officials could bolster demand by encouraging the use of flu shots.

Miss Grant also said companies need more assurances of liability protection.

Health officials say companies also must take responsibility for overcoming the flu vaccine shortage. Health and Human Services Secretary Tommy G. Thompson is urging the development of faster methods to produce vaccine.

Flu vaccine is prepared in fertilized chicken eggs. The eggshell is cracked, and the influenza virus is injected into the fluid surrounding the embryo. The egg is resealed and the embryo is infected. The virus develops in the egg, then is removed and used to produce vaccine.

Congress allocated $50 million in the 2004 budget to begin improving flu vaccine production. That was half the amount federal health officials requested, Mr. Thompson said, and last week he asked lawmakers to provide the requested $100 million for next year.

A new approach that uses cellular engineering could reduce the time it takes to produce vaccine and give companies greater flexibility to respond to an increase in demand. Cell-based vaccines also would give companies more time to determine which strain to target before they have to begin production. Now they must begin production in January so it is ready by September.

Baxter and ID Biomedical are working on cell-based flu vaccines.

“It appears [the cell-based approach] cuts several weeks off the production process,” Mrs. Spak said.

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