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Why U.S. supply of flu vaccine fell short

By Fred Tasker and Seth Borenstein
Knight Ridder Newspapers

	BOB KARP / AP Hundreds of people line up in the parking lot outside the Mendham Apothecary in Mendham, N.J., to receive 1,000 flu shots distributed last Friday by Pennsylvania-based Quaker State Medical Services. People started lining up three hours before the vaccinations began.
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U.S. health officials and drug companies say it was mostly bad luck, and the difficulties inherent in making vaccines.

Critics say it was flawed decisions by both of the above. And they say officials should be more candid that this year's flu vaccine was formulated to protect against three older strains of the virus, but not against the new strain racing across the country.

All agree the country's system of producing vaccines will continue to fail until the public demands that it be fixed.

It's not just flu. In the past two years, scientists say, there have been vaccine shortages for diphtheria-tetanus-whooping cough, measles-mumps-rubella, pneumococcal disease and chickenpox.

This year, doctors in Colorado already are rationing flu shots, giving them only to people in high-risk categories, including the young, old, chronically ill, health-care workers or family members of those at risk.

It's partly because drug firms made 12 million fewer flu shots this year than last.

Reforms sought The Centers for Disease Control and Prevention in Atlanta has asked Congress for $100 million for vaccine reforms including: • Seeking faster ways to make vaccines, using mammalian tissue and genetic-engineering methods that are in research but not yet perfected • Estimating more accurately the number of high-risk people who most need the shots • Learning why so many such people aren't getting the shots • Defining the market more carefully so drug companies know how many shots to make, and/or guaranteeing to pay the companies for unsold vaccines, perhaps at a negotiated discount • Persuading more drug companies to make vaccines

Here's what happened: Since the killer flu season of 1989-90, flu outbreaks have been mild. Demand for flu shots has been declining, and, since the shots officially expire in June following each flu season, drug companies in each of the past five years have discarded unsold shots.

Last year they made 95 million shots, sold 83 million and discarded 12 million.

"At $10 a dose, they lost $120 million," said Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention.

Last March, experts from the World Health Organization, the CDC and the Food and Drug Administration gathered to evaluate last year's flu season and plan for this year's. It was known then that a particularly virulent flu strain, Fujian, was active in Asia. But scientists did not immediately recognize its danger.

Also, Gerberding said, researchers trying to create an effective, mass-producible vaccine against Fujian were having serious trouble.

Still, a decision was imperative, because flu-shot production takes several months, and this year's flu season loomed.

So in March, Gerberding said, the experts "independently but simultaneously decided it would not be prudent to race to get the Fujian strain in this year because it could jeopardize the whole vaccine production, and we would start the year with no vaccine at all."

So they decided to make this year's vaccine identical to last year's. They figured that since the vaccine was 70 to 90 percent effective against last year's Panama flu strain, which is similar to the Fujian strain, it should provide some protection against the Fujian.

	TOM STRATTMAN / AP A nurse prepares a flu shot at a clinic in Noblesville, Ind.

That was a bad decision, says Barbara Loe Fisher, president of the consumer group National Vaccine Information Center and a member of an FDA advisory committee. She abstained in the committee's March 18 strain-selection vote, explaining: "It's not right to lead people to believe that if they get vaccinated now, they will be protected."

Another member of that committee, Dr. Theodore Eickhoff of the University of Colorado, estimated this year's vaccine would be less than 50 percent effective in preventing the flu.

Gerberding admits: "We won't know for several weeks or months exactly how close that cross protection is."

A major question for drug companies: Knowing the Fujian strain was spreading, shouldn't they have concluded that vaccine demand might grow this year? And, believing the vaccine they were making would provide at least some protection against it, shouldn't they have made more?

"We were aware of the Fujian strain," says Len Lavenda, spokesman for Aventis Pasteur, one of two U.S. makers of flu shots. But he said Aventis made 48 million doses in 2001 and 2002 and, after each flu season, discarded 5 million unsold shots. For 2003 they made 43 million.

"We were coming off several years of declining demand," he says.

Most years, the company adds up all of its vaccine preorders and makes an extra 20 percent. This year, knowing about Fujian, they made an extra 35 percent.

"This is the first year we've ever run out," he says.

University of Michigan epidemiologist Dr. Arnold Monto points out that drug companies knew demand would be up because Wyeth Pharmaceuticals was dropping out of making flu shots to handle a new product, the anti-flu nasal spray FluMist.

Monto says the larger problem is that doctors are not ordering enough flu shots: "People's memories are short because the past several years have not been big flu years."

If every American at high risk from flu were inoculated, Monto says, it would take 185 million shots. Last year drug companies couldn't sell 95 million.

"We need better education of the public that they need to get a flu shot every year," he says. "And the government should guarantee to buy doses if they're not used so the companies don't lose money."

An even broader issue is the chronic shortage of vaccines for diphtheria-tetanus-whooping cough, measles-mumps-rubella and chickenpox.

"Our vaccine system is broke," says Frank Sloan, of Duke University, who chaired a vaccine study by the National Academy of Sciences' Institute of Medicine.

The study cited "delays in reimbursement to health-care providers for vaccine costs, shortages in the supply system, dwindling numbers of vaccine makers in the U.S., and gaps in the coverage of recommended vaccines by private health plans."

In 1967, nearly 30 U.S. companies made vaccines; now there are only five.

Vaccines aren't very important to drug companies, the report concluded, because only 1.5 cents per dollar of drug-company revenue comes from vaccines.

Copyright © 2003 The Seattle Times Company