Flu-shot worries spur debate over federal role

Dick Landis's doctors want him to get a flu shot. He just can't find one. He tried the pharmacy at his local Safeway store, just as he had last year. "They just didn't have it," says the 67-year-old from Woodburn, Ore. Then he asked his wife, a registered nurse, if she knew of a source. She couldn't help. He's still looking.

Reports of long lines of senior citizens around the United States seeking flu shots have put an exclamation point on this fall's unexpected shortage of influenza vaccine. In a survey of hospital pharmacists last week, 55 percent reported having been contacted by vendors offering flu vaccine for as high as $80 per dose, 10 times the market price during ordinary times.

But this week, Tommy Thompson, the secretary of Health and Human Services, said that the vaccine shortage does not represent a health crisis and has encouraged Americans to "relax" and skip waiting in line, assuring them that there would be shots for most of the people who needed them. And while such forecasts are notoriously difficult to make, flu experts say some early signs suggest that this winter's outbreak may be milder than usual.

Still, the mood approaching panic in the past week has prompted calls for government agencies to intervene to better ensure vaccine supplies in coming years. The resulting debate could center around whether the complexities of this market require government intervention.

This year's challenge emerged earlier this month, when the US Food and Drug Administration announced that all 48 million doses of flu vaccine from Chiron Corp. in Britain were contaminated and could not be used. They represented nearly half of all the doses expected to be available. The only other manufacturer licensed in the US, Aventis Pasteur, will make about 54 million doses. In addition, 1 million to 2 million doses of a nasal spray vaccine are expected to be available, although it is not recommended for young children or the elderly - those considered most at risk from the flu. Last year, 83 million Americans were immunized, including about 60 percent of the elderly.

In a prescient report issued Sept. 28, just before the vaccine shortage was announced, the US Government Accountability Office criticized US flu vaccine preparedness and warned of possible shortages if a manufacturer's production were to be interrupted. The GAO report concluded, "there is no system in place to ensure that seniors and others at high risk for complications receive flu vaccinations first when vaccine is in short supply."

Amid media coverage and public concern, some experts say perspective is needed. The term "flu vaccine shortage" isn't quite correct, says Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "We'll actually be vaccinating more people this year than we vaccinated in 1999. Part of what's happened is a major escalation in the number of people vaccinated because there's been such an active promotion of flu vaccine."

The US gives flu vaccine to the highest percentage of its population of any country in the world, Dr. Osterholm says, adding that even this year the percentage will be among the highest in the world.

This year's lack of preparedness should be a matter of concern, he says, but he predicts the lower rate of immunization is going to be "a relatively minor blip in the public health world" compared with more pressing concerns, such as the potential for Avian flu, a different disease considered much more serious, to be transmitted to humans and spread globally.

Still, the flu is considered a significant problem, to which 36,000 deaths and 200,000 hospitalizations are attributed every year - mostly among the elderly.

"It's obvious that the vaccine supply system is very fragile and that we can't assure supply," says Dr. Myron Levin, chief of pediatric infectious diseases at the University of Colorado School of Medicine and a member of the Advisory Committee on Immunization Practices, which counsels the federal government. He's heard little serious discussion of the government taking over vaccine production. "I think most people have felt we'd do better to find some other mechanism to improve the supply, not have the government take it over."

To guard against future shortage, the federal government "might want to order much more vaccine than it's ever going to use with the understanding that we might never use it" as "a backup," he says. And employing more manufacturers than the current two would mean that losing any one of them would be less damaging.

But it is a tedious and time-consuming product to create, involving the inoculation of hen's eggs. Other vaccines can be stockpiled for years, but flu vaccine must be made annually to match current strains of the disease.