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How U.S. Got Down to Two Makers Of Flu Vaccine

This year, for the first time, the CDC recommended universal flu vaccination for all children 6 months to 23 months old. For several years, it has had a huge campaign to vaccinate the elderly and chronically ill, only half of whom typically get a flu shot. Some experts believe it's only a matter of time before the agency advises every American to get a flu shot each year.

Ironically, though, even that prospect isn't likely to be enough to lure companies back immediately.

For two decades, Wyeth made injectable influenza vaccine at this plant in Marietta, Pa., which it eventually closed. (Kalim A. Bhatti -- The Philadelphia Inquirer)

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The reason is that nobody wants to invest hundreds of millions of dollars and five-to-seven years in building an egg-based vaccine plant when the whole industry is on the verge of switching to a radically new way of making the product.

Sometime in the next decade, flu vaccine will start to be grown in cell cultures, not eggs. It is a technology far more clean, predictable and expandable than the egg-based way of old.

The National Institute of Allergy and Infectious Diseases is trying to speed that day with a $11 million-a-year program in which dollar-for-dollar matching grants are being made to four companies trying to develop commercially viable techniques for growing flu virus in various types of cell culture.

The companies will get the fruits of the research. The taxpayer may get a better and more predictable vaccine supply for its investment.

Merck & Co., which makes seven vaccines and has four new ones in late testing, stopped making flu vaccine in 1986. But that product might begin to look attractive again if there were a way of making it in cell culture, said Adel Mahmoud, president of Merck Vaccines. If research being done elsewhere showed that it were possible to make a flu vaccine that didn't have to be updated each year, that "would be very, very attractive," he said.

But technology and science aren't the only things waiting to mature in the world of flu vaccine, experts said. So is social policy.

Gregory Poland, of the Mayo Clinic, favors a system of incentives: Vaccine makers would make a given number of doses of flu vaccine for the private market at their own risk; a given number for government purchase; and an additional amount that the government would agree to buy back at a specified price if there were unsold stocks at the end of the season.

Other experts agree that only some form of direct government incentive is likely to solve the problem of a small and vulnerable manufacturing base.

Donald Burke, director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, favors "a fixed and mutually beneficial relationship" between the government and companies that make vaccines against bioterrorism agents. He's coming to think the same may be the solution for flu, too.

"I think it's in our national interest to promote 'health security' as well as national security," he said last week. "I would be inclined to extend the model of government-industry cooperation to diseases in the 'health security' arena, such as flu, as well."

Paradiso, at Wyeth, concurs.

"It's not that we need a new vaccine. What we need is a stable supply. We need to figure out how to make that happen."

For the foreseeable future, however, Wyeth will not be involved. The Marietta site -- founded by a local doctor in 1882 as the Lancaster County Vaccine Farm -- is up for sale.

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