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The intense demand for flu vaccine, fueled partly by its scarcity, has many wondering how the richest nation in the world could be caught so unprepared. Health officials say we have 300 million doses of smallpox vaccine, yet Americans in their 70s and 80s are waiting in line, sometimes for hours, to get a flu shot.
Nearly two weeks ago, vaccine maker Chiron said it could not supply up to 48 million doses of vaccine as promised from its plant in Liverpool, England, because British regulators had suspended its license. The Food and Drug Administration completed its own inquiry Friday and concluded none of the vaccine made there could be used.
The next question: What now?
''It's important to know why the FDA seems to have dropped the ball,'' says U.S. Rep. Henry Waxman, D-Calif., a member of the House Committee on Government Reform, which expects to receive FDA documents this week in an effort to unravel the timeline of events. ''The British regulators conducted a full inspection of Chiron. The FDA took Chiron's word for it that everything was OK. I think the agency has become too close to the drug industry.''
Acting FDA Commissioner Lester Crawford has strongly defended his agency's actions, saying it handled the Chiron situation by the book.
Under the current system, HMOs, hospitals, doctors, health departments and companies that run flu vaccine clinics place orders with distributors or directly with vaccine makers, usually by February or March. Because flu vaccine takes about six months to produce, relying on decades-old technology in which vaccine is grown in millions of chicken eggs, vaccine makers need that much lead time to know how much to produce. They generally make more than ordered as a cushion but never enough to supply the 185 million for whom annual flu shots are recommended -- mainly the elderly, the infirm, health care workers and, as of this year, babies 6 months to 23 months old.
There has never been a need for that much vaccine. The most ever sold is just over 83 million doses last year.
''It's becoming the conventional wisdom that our (vaccine) infrastructure is quite flawed,'' says Martin Blaser, chair of medicine at New York University and president-elect of the Infectious Diseases Society of America. ''Manufacturers have left the field because of various problems. We don't have a national policy to encourage development of vaccines.''
Some experts say the shortage suggests that reliance on a free-market system to ensure basic public health safety may no longer be effective, and government may need to take on a greater role, as it has with regard to smallpox and other bioterrorism threats.
''This has taught us that the consequence of leaving it to market forces leaves the country as a whole without any rational distribution plan,'' says former New York City health commissioner Pascal Imperato, chief of preventive medicine and community health at State University of New York-Downstate in Brooklyn.
Scientists saw it coming
The shortage has shocked Americans, but scientists have predicted it for years. As recently as Sept. 28, the Government Accountability Office, the investigative arm of Congress, warned that a severe flu vaccine shortage could occur and that there is no system to ensure that high-risk people get the vaccine first.
Reports from the Institute of Medicine and GAO since the late 1990s have pointed out problems concerning vaccines: They're difficult and time-consuming to make; they require expensive technology to meet rigorous quality standards; they're subject to litigation from consumers who have bad reactions or who blame vaccines for problems such as autism; and they have relatively low margins of profit.
Flu vaccine, in particular, costs doctors less than $10 a dose. Whatever is unsold at the end of the flu season has to be dumped because the vaccine changes every year, as different flu viruses circulate around the world.
Not surprisingly, drug companies have gotten out of the vaccine business, seeking the greener pastures of blockbuster drugs to treat erectile dysfunction, diabetes or high cholesterol. Ten years ago, there were four companies making flu shots; today, there are two.
There is no telling how bad the coming flu season will be. Flu can be dangerous for the old and infirm -- about 90% of the 36,000 who die of flu each year are elderly. But for most healthy people, it's ''little more than a nuisance,'' Imperato says. Because of that, Americans tend to underestimate the disease's impact, and, until this year, shrug off advice to get a flu shot. In turn, manufacturers limit production, fearing they'll be left with millions of unused doses. In 2002, companies had to toss out roughly 12 million doses.
Health and Human Services Secretary Tommy Thompson says the government is looking at ways to stabilize vaccine production, including supporting new technologies for speedier vaccine produc- tion and encouraging new companies to enter the market.
Who gets the vaccine?
Across the country, health departments are struggling to decide how to allocate limited supplies of vaccine. Most are complying with federal recommendations to vaccinate only those at highest risk of serious illness from flu, but there is not enough for everyone in the high-risk groups, and they're having to make difficult choices. Who should get vaccine first, an 85-year-old or a teenager with asthma? How can a doctor choose between a transplant recipient or a nurse who cares for AIDS patients?
Those questions haven't been answered. The Centers for Disease Control and Prevention is scrambling to figure out who has vaccine and where it's needed most, advising people to be patient as Aventis Pasteur, the sole surviving maker of flu shots for the USA, gets vaccine made and shipped out as fast as it can, at the rate of more than 2 million doses a week. But the company, which expects to make a total of 55 million doses for the season, has shipped most of it already.
Several state health departments have declared an emergency so they can limit distribution to those in greatest need, and take action against distributors who are reportedly charging 10 times the usual price for vaccine. A handful of thefts of vaccine have been reported across the country, and clinics are running out of vaccine, having to turn away people who have stood in line for hours.
Scared, from East to West
The effect of the shortage is evident nationwide. In Colorado, where 12 children died of flu last season, thousands of people are jamming clinics in doctors' offices, senior centers and grocery stores. Kaiser Permanente, the state's largest private health provider, was expected to use up the last 5,000 of its 100,000 doses by today. Hundreds of clinics in workplaces and churches have been canceled.
''I'm worried about it. Even my asthma doctor'' can't get vaccine, says Eric McPhee, 35, who waited two hours for a vaccination at a supermarket in Littleton, a Denver suburb. McPhee and his sons, Kenton, 6, and Camden, 4, all have asthma, which puts them in the priority group.
In Lawrenceville, Ga., Henry Brown, 78, waited behind the wheel of his 1995 Oldsmobile a few blocks from the county health department on Friday, inching forward a few feet every few minutes, moving toward a flu shot. A day earlier, Gwinnett County had received 2,500 doses of vaccine. The news caused a run at the health department: People started lining up at 5:30 a.m., some driving from more than 70 miles away.
Brown says he has never seen this kind of crowding. ''It really makes you worry a lot. I've never had the flu since I've been taking the shots, and since I'm old now, I'm scared to not take the shot.''
He finally makes it to the front of the line. A woman takes his paperwork, checks his Medicare card and waves him ahead. Another woman pushes up his sleeve, gives him the injection and it's over.
''This is good, ain't it?'' Brown says. ''Now I can relax and get some rest.''
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