ST. LOUIS – People who can’t find a flu shot want to know who is to blame for the shortage.

The answer, experts say, is a system that pits public health measures to protect people from a deadly virus against free market forces, which encourage vaccine makers to invest resources elsewhere.

Public health officials have waged a campaign against the flu virus for years, urging people to get annual flu shots. Medicare began reimbursing for the vaccine in 1991 and demand has risen steadily since, topping 83 million doses last year.

But manufacturers have slowly dropped out of the vaccine business, leaving the United States with only two major companies, Aventis Pasteur and Chiron, to produce more than 100 million flu shots.

When British regulators suspended Chiron’s license because of contamination in its plant in Liverpool, England, earlier this month, nearly half of the U.S. supply vanished.

A third company, MedImmune, makes a nasal spray flu vaccine called FluMist. The product flopped in its maiden year, last year.

This year, MedImmune made only about 1.1 million doses of the nasal vaccine, but announced it would provide another 2 million doses by the end of December.

The company is conducting clinical trials to gather data needed to license the spray for use in children six months to 5 years old. The product is approved for use in healthy people aged 6 to 49 and is an alternative to the injected vaccine for school children, health care workers and caretakers for people in risk groups.

FluMist’s disappointing debut followed a disastrous 2002-2003 flu season for Wyeth, said Doug Petkus, a company spokesman. Production problems delayed the company’s shipment. Wyeth ended up throwing away 7 million of the 20 million doses it made that year, Petkus said. That topped off losses of about $50 million over the previous five years, he said.

Wyeth decided to focus its resources elsewhere, notably on a childhood vaccine against pneumococcus, a type of bacteria that causes meningitis and pneumonia. The company is the sole producer of the pediatric vaccine.

Pharmaceutical giant, Merck, stopped making flu vaccine in 1986 so it could concentrate on other childhood vaccines, said spokeswoman Christine Fanelle. Merck is the only producer of the adult pneumococcus vaccine.

“It’s a very unfortunate situation. It speaks to the health of the industry that for most vaccines there is only one manufacturer,” Fanelle said. “We think the environment needs to change.”

Infectious disease experts are calling for more attractive regulatory and financial conditions to entice companies back into the vaccine market.

“Many vaccine producers feel the U.S. regulatory bars are too expensive,” said Dr. Andrew Pavia, chairman of the task force on pandemic flu for the Infectious Disease Society of America and an infectious disease expert at the University of Utah.

The society would like to work with U.S. regulators to streamline the vaccine licensing process, he said. Canada and European countries also have stringent safety standards, but those countries require less expensive clinical trials to license vaccines.

“We need to figure out what’s costing manufacturers a lot of money, but not buying us extra safety,” Pavia said.

Liability concerns and uncertain demand for the products are also concerns for vaccine-producing companies.

“You need to have a market. Vaccine demand is something that sort of waxes and wanes depending on public enthusiasm,” said Dr. Walter E. Stamm, president of the Infectious Disease Society of America.

Flu vaccine has been more disposed of more often than desired. Every year, up to last year, companies could count on throwing away about 10 percent of the flu vaccine they made, Stamm said.

“In some years, people may not come to the clinics no matter how much vaccine you have,” Stamm said.

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The Visiting Nurse Association puts flu shots in the arms of up to 50,000 people in the St. Louis area each year. But up until last year, the nurses were left with unused doses of vaccine at the end of flu season, said Susan Pettit, president and chief executive of the association. Sometimes only a few hundred doses remained. At least once 10,000 doses were left over.

The nurses turn extra vaccine over to the health department for proper disposal, but absorb the cost. Some manufacturers buy back unused vaccine and take the financial hit.

“We’re stuck and the drug manufacturers are stuck too,” Pettit said.

Flu shot providers try to forecast in February how many doses they will need in October and November, Pettit said.

“It really is a crap shoot every year,” she said.

Her estimates have been fairly accurate in the past few years, but Pettit admits to ordering conservatively. Sometimes, like last year, the association can buy more vaccine if demand is greater than anticipated. But this year, once the 7,000 doses the association bought from Aventis runs out, there will be no more. The association ordered 90 percent of its vaccine from Chiron.

It’s a mistake Pettit has no plans to repeat.

“We will not put all of our eggs in one basket this year,” she vowed.

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Some people have called for the government to guarantee a market for vaccines, either by buying and distributing the vaccine or agreeing to buy any unused doses.

Government vaccine production has failed in the past, said Dr. Robert Belshe, director of the Center for Vaccine Development at St. Louis University. States used to make and distribute vaccines, but realized that private sector companies were better suited to the task. The government moved to regulating vaccines and left production and distribution to the free market.

For the federal government to undertake vaccine manufacturing “would require a major change in policy. It probably wouldn’t work, and it would be fraught with all of the headaches of government-run programs,” Belshe said.

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Only about 5 percent to 10 percent of the vaccine in the United States is purchased directly by the government for use in federally mandated programs, said Dr. Bruce Gellin, Director of the National Vaccine Program Office. Private providers, such as doctors, pharmacies, nursing homes, colleges and corporations, buy the bulk of vaccine.

The private system makes vaccine doses hard to track and redirect, Stamm said.

“There’s great difficulty in figuring out exactly where it’s going and to whom it’s going,” he said. The CDC has asked vaccine providers to give the shots only to people in risk groups, and is working with Aventis to direct remaining vaccine to elderly people this year.

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The process of making flu vaccine also makes it less attractive for manufacturers. The process takes months. Automation is not an option. Each dose of flu vaccine is a hand-crafted product. Eggs are injected by hand with a strain of flu virus. Each egg serves as an incubator for the virus and conditions inside vary. Occasionally the virus doesn’t grow well and vaccine delivery is delayed. That scenario has played out several times in the recent past.

Sometimes the virus grows well. Last week Aventis announced that it would be able to provide 2.6 million more doses of flu vaccine, thanks to better than expected virus growth.

New technologies could eliminate spotty production, stabilize the vaccine supply, and speed up the process, Belshe said. The SLU vaccine center he heads is working to improve vaccine production and looking for new ways, such as skin patches and nasal sprays, to administer the vaccine. Such research could improve the situation over the long-term but will do nothing to solve immediate concerns.

“It’s literally years, or even decades, before new technologies reach the public,” he said.

Health and Human Services Secretary Tommy G. Thompson said the government is investing in cell culture techniques and new vaccines to head off future crises. And public health and regulatory officials are scouring the world for vaccine that could ease the current shortage, he promised.

“Even though it looks serious now,” he said, “there are some bright spots in the future.”



(c) 2004, St. Louis Post-Dispatch.

Visit the Post-Dispatch on the World Wide Web at http://www.stltoday.com/

Distributed by Knight Ridder/Tribune Information Services.

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GRAPHICS (from KRT Graphics, 202-383-6064): 20041022 Flu deaths, 20041008 Flu risk groups

ARCHIVE GRAPHIC on KRT Direct (from KRT Graphics, 202-383-6064): 20041006 FLUVACCINE cycle

AP-NY-10-23-04 1431EDT



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