The flu and you
With shortages everywhere, authorities are trying to quell panic and reassure the public that the vaccines are coming
Ralph Loschiavo had some real bad luck recently. The 78-year-old retired stonemason was in line at 8:30 a.m. at his local Eckerd's drugstore for a flu clinic. "But they stopped giving shots eight people in front of me." The next day Loschiavo was turned away at a supermarket. Hoping that No. 3 would be the charm, he gamely joined another line--of elderly people in folding chairs and on walkers outside Shoppers Food Warehouse in Crofton, Md., about 8 a.m. By 1 p.m. Loschiavo was close to the front, holding his assigned number, 217, when the nurse from Maxim Health Systems announced that she had administered all the available doses, 215.
Loschiavo shook his head. "I'm 78, I have one lung, and I had a quintuple bypass. I usually get my flu shot at the doctor, but they told me they had no vaccine and I should go to one of the grocery stores. We stand in these lines for what?"
Loschiavo's dilemma was shared by thousands of elderly and chronically ill people across the country who braved hail, rain, and excruciatingly long waits to receive their shots. Federal health officials tried to quell panic and reassure the public last week that more flu vaccine was on the way. Aventis-Pasteur, now the only flu-shot maker licensed to sell vaccine in the United States, agreed to produce 2.6 million more doses of vaccine by January 2005, to supplement the 55 million it had already contracted to provide. Taken together with 3 million doses of FluMist, a nasal spray vaccine approved for those ages 5 through 49, the United States will have nearly 61 million doses of vaccine--about 22 million shy of those administered last year.
The problem started October 4, when British health authorities shut down the Chiron Corp. manufacturing plant because its flu vaccine had become contaminated with bacteria. By that time, more than half of Aventis's vaccine--33 million doses--had been shipped. "How much of that 33 million doses is being administered to treat high-risk groups or had already been administered to high- or low-risk groups? That's an unknown," says Mitchell Cohen, an infectious-disease official at the Centers for Disease Control and Prevention. And trying to track those doses down, says William Schaffner, chairman of preventive medicine at Vanderbilt School of Medicine, "is like trying to herd cats."
Priorities. After the Chiron closure, federal health officials set guidelines for distributing the limited supply of flu vaccine that remains, perhaps 25 million doses, to as many as possible of the estimated 98 million Americans who need it most. These include people 65 and older and those with chronic illnesses and compromised immune systems, young children ages 6 to 23 months and their caregivers, pregnant women, nursing home residents, and healthcare workers.
Despite the recommendations, there were reports that some vaccine was being administered to healthy people not listed in the CDC guidelines. Last week members of Congress, Capitol Hill staffers, college students, and others were being vaccinated. At the same time, many hospitals and clinics were without vaccine for their sickest patients. Secretary of Health and Human Services Tommy Thompson urged Americans to be "patient and persistent," while insisting that "we have a healthy supply of vaccines and medicines to cope with flu season." Yet, as hundreds of U.S. citizens crossed into Canada for flu shots at double the U.S. price, and doctors who treat cancer and AIDS patients planned vaccine-buying trips abroad, it was clear that dire shortages were the norm, not the exception.
"This is a huge shortage," says Patrick Libbey, executive director of the National Association of County and City Health Officials, which is working with the CDC to get vaccine out to those in need. "A national message saying, 'Not to worry, there is vaccine on the way,' in many cases appears to be increasing distrust. People show up at the clinic sites or at public health departments and are then told, 'No, we don't have enough.' [That] creates more distrust."
Decisions, decisions. The enormity of this shortage is only now becoming clear. Many research hospitals across the country were low on vaccine or completely out last week. Johns Hopkins Hospital ordered 25,000 doses from Chiron and got none. After two weeks of looking for vaccine to buy, Hopkins now has about 1,400 doses. "We normally need about 30,000 doses of vaccine a year," says Trish Perl, the medical center's epidemiologist. "We have two high-risk populations--people who have high-risk medical conditions and healthcare workers." Studies have shown that vaccinating healthcare workers reduces patient mortality by 50 percent, Perl adds. Hopkins is reserving some flu shots for patients, but the CDC guidelines are so broad that medical providers will be forced to make untenable decisions, says Perl. "Do you give it to the kid with cystic fibrosis, or a transplant patient, or a pregnant female?"
Many public-health experts say the government is not going to cope with this flu season or any other until the vulnerable system by which vaccines are produced, paid for, and distributed is overhauled and updated. By any measure, influenza is a serious disease for the nation. Every year, more than 36,000 people, mostly elderly, die of influenza and its complications, such as pneumonia, and more than 200,000 are hospitalized.
Vaccine shortages have plagued the nation for over a decade in part because the number of companies making vaccines has been shrinking. Ten years ago, there were five companies making flu shots; today there are two. There is one producer for many essential vaccines: tetanus, chickenpox, measles, mumps, rubella, polio, and both the childhood and adult pneumococcal vaccines, which protect against pneumonia and invasive infections such as meningitis. Manufacturers leave the business because compared with pharmaceuticals, vaccines are not terribly profitable. Flu virus strains change from year to year, necessitating a new flu vaccine every season. "It's technically demanding, even risky," says Vanderbilt's Schaffner, a member of the HHS National Vaccine Advisory Committee. "And it's a low-profit item."
This year, the U.S. supply was cut in half overnight when Chiron was shut down. It was not, however, the first time a contamination problem had been discovered at the company. Back in August, the U.S. Food and Drug Administration also found bacteria in some lots of Chiron's vaccine. But both the FDA and the company believed the problem could be fixed in time to deliver some 46 million doses of flu vaccine to the United States. To date, none have been received.
The CDC is reallocating some of the Aventis vaccine to state health departments that have none. State officials are charged with getting the vaccine to their most vulnerable populations. In Oregon, for example, with a population of over 1 million high-risk residents, using 9,300 surplus doses the state recovered and the more than 224,000 doses received from Aventis to date, health authorities there have been able to vaccinate only about 22 percent of the state's high-risk residents this winter, instead of the usual 50 percent in an average flu season.
What this will almost certainly mean on a national level is higher healthcare costs related to flu, more hospitalizations, and more deaths. There are no official estimates yet on how much the flu vaccine shortage may cost, but David Cutler, a professor of economics at Harvard University, estimates it may go as high as $20 billion in doctor and hospital payments and productivity losses. Compared with the $13 billion to $15 billion a typical season costs, the increase is significant.
"Land rush." Report after report from the Institute of Medicine, the National Vaccine Advisory Committee, the Government Accountability Office, and other bodies have warned of a coming flu vaccine shortage. The GAO has consistently urged the CDC to come up with a plan for quickly distributing flu vaccine to high-risk groups. In fact, says the CDC's Cohen, such a plan can be developed only on a case-by-case basis, as he and other CDC officials are doing now. This seat-of-the-pants approach, however, is sowing lots of confusion. "The current system is like a land rush," says Jeffrey Koplan, a vice president at Emory University and former director of the CDC. Koplan's 83-year-old aunt waited for two hours at one Long Island, N.Y., supermarket and three hours at another to get a flu shot last week. "It's one thing to say here are the folks who should get the vaccine, and it's another thing to make it more practical and easy to take place."
Ultimately, says Koplan, the government is going to have to guarantee that a certain number of doses will be purchased. "Guaranteed purchase of vaccine is the one thing we could do that would make an immediate difference," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Most experts agree that this is an investment worth making. Vaccines "dwarf every other medical advance that has been achieved," says Koplan. "To not support them adequately is a grave error."
Late last week, Ralph Loschiavo's luck changed. His doctor called to say the practice had received a few doses of flu vaccine. They'd selected Loschiavo and seven other patients to get flu shots. He was pleased. "But," he says, "something has to change."
Priority groups to receive the flu vaccine
(2002-03 population in millions)
Pregnant women 4
Children 6 to 23 months 5.9
People in contact with babies less than 6 months 6.3
Healthcare workers 7.0
People over 64 35.6
People with chronic illness 39.4
Source: Centers for Disease Control and Prevention
USN&WR
With Nancy Shute
This story appears in the November 1, 2004 print edition of U.S. News & World Report.