The national smallpox vaccination plan rolled out with a whimper last week. Part of the Bush administration's effort to stave off a bioterrorism attack, the vaccination plan was to begin with a strong start in the state of Connecticut by vaccinating 20 or more first-line medical responders who would then fan out and vaccinate thousands of other doctors, nurses, and emergency room personnel around the state. In the coming weeks, other states will join in and inoculate 500,000 first-line medical personnel in all major medical centers in the country against smallpox. Eventually 10 million more health care workers, firefighters, police, and emergency medical personnel will receive the vaccine.
But in Connecticut, only four people showed up to get the shot, and three of those were administrative personnel--the state epidemiologist and two administrators at the University of Connecticut's Health Center. The numbers willing to volunteer for the shots had been dwindling all week, as hospital associations, nursing unions, and other professional groups balked at the risk of the smallpox vaccine itself and raised important questions about the true potential for a smallpox terrorist attack. At last count, more than 80 hospitals around the nation, including major teaching hospitals and medical centers in urban areas, have opted out of the vaccination program.
What's going on here?
The smallpox vaccine is made from a live virus, vaccinia or cow pox, which is a cousin of smallpox. It can cause illness in a significant number of vaccine recipients. Experts estimate that about 1,000 out of every one million who receive the vaccine will experience serious side effects, about 40 of those will be life-threatening illnesses, and one or two of those people will die from it. So, of the 10 million expected to get the shots, 10,000 are expected to get sick, 400 will be threatened with death, and 20 are expected to die outright from the vaccine alone.
But, as critics have pointed out, this is a gross underestimate of the risks. People who are vaccinated carry an open wound in their arm, which sheds the live vaccinia virus for up to three weeks. Certain people who come in close contact with them can become quite ill. At particular risk are infants under a year old, pregnant women, elderly people, folks with eczema and skin disorders (who can absorb the disease through breaks in their skin--an estimated 7 to 20 percent of the general population has had such skin disorders) and, most ominously, people with lowered immune system response.
There are an estimated 60 million people in the US today living with weakened immune systems, and most of them are suffering from HIV/AIDS or undergoing a medical treatment that didn't exist 35 years ago when smallpox vaccinations were routine. People with AIDS, cancer patients undergoing chemotherapy or radiation treatments, burn patients, and organ donor recipients would all be put at an unacceptably high risk of death if their nurses and doctors are vaccinated for smallpox.
It's a peculiar form of torture to ask a medical person who has dedicated his or her life to saving other peoples' lives to risk killing patients because of vague fears of a bioterrorist attack. Doctors and nurses, in particular, have a good sense of the potential threat various diseases pose to their patients. As William Schaffner, head of preventive medicine at Vanderbilt University Medical Center in Nashville, said: "The thing that stops you from doing this is the complexity of the smallpox vaccine, which is not a safe vaccine. There's a real disease that kills people unnecessarily: the flu. Mr. President, I would love to see you endorse a national flu vaccine campaign with the same vigor." Medical centers around the country, however, have had to deal with recent flu vaccine shortages. Smallpox is simply not high on their list of concerns.
Some officials caution that a smallpox attack is a real possibility. All it would take is one person to infect himself, travel to a major metropolitan area, and hang out a nearby shopping mall, sports arena, or other crowded public place to begin infecting people, they argue. There are many problems with this scenario, including the fact that smallpox has effectively been eradicated, with no new cases reported since 1977. The only known laboratory stocks of the disease exist in highly quarantined labs in the US and Russia. And if smallpox cultures were smuggled out of Russia or the US, it's not at all certain that terrorist groups could get their hands on them or turn them into a usable weapon.
Even in the lone, kamikaze, infected terrorist scenario, the outbreak might not be as bad as Bush administration advisors assume. Leading smallpox experts say that nowadays we have conditions that are less conducive to the massive outbreaks of the past, when people lived in extended families in crowded rooms, with multiple family members sharing the same bedrooms and the same beds. People wash their hands more and more people travel alone in cars and live in less crowded conditions. We use strong disinfectants more often, and air and water is filtered and treated for contaminants. A realistic scenario of one person falling ill and then going through his or her day--even visiting a shopping mall and going to work--shows that only one or maybe two other people would be infected with smallpox before the sick person was sent to a hospital. In that kind of scenario, quarantine and area-specific vaccination would work well to contain the disease.
Joining the critics of the Bush administration's smallpox vaccination plan is Bill Foege, former chief of the Centers for Disease Control and consultant to the National Academy of Sciences' Institute of Medicine panel on bioterrorism preparedness. Foege is a global health adviser to the Bill and Melinda Gates Foundation, which is spending hundreds of millions of dollars on major vaccination initiatives in Africa and helping to fund the search for an AIDS vaccine.
In other words, Foege is definitely not a foe of vaccination in general. In the 1960s, when he worked for the CDC in Africa, Foege developed a specific plan to vaccinate for smallpox that minimized the exposure to the vaccine and yet helped to wipe out the disease in that part of the world. His method, called "ring vaccination," relies on a special property of the smallpox vaccine: it can protect people who've already been exposed to the disease if they're given the vaccine within four days of exposure to the disease.
Foege argues that ring vaccination should be used here in the United States, and other medical administrators are beginning to agree with him. Richard Wenzel, chairman of internal medicine at Virginia Medical College at the University of Virginia, was faced with a crisis in the fall of 2001. During the height of the anthrax attacks, he received word that a patient with smallpox had been found and was being sent to his hospital. He quickly formulated a plan that would quarantine the patient and assign specific personnel to treat him who had been vaccinated as children. Wenzel located some smallpox vaccine for his hospital staff. As it turned out, the patient didn't have smallpox. But Wenzel now believes that it would be safer and more cost-effective for hospitals to draw up quarantine plans, stockpile smallpox vaccines, and use them only in the face of a real outbreak. Here in Seattle, the major public hospital, Harborview, is currently considering this approach.
Cost is also a major issue. The federal government is not providing funds to hospitals to help them deal with staff shortages if and when their nurses and doctors fall ill from the vaccinations. Some hospitals are worried about lawsuits from patients' relatives if they're exposed to the live vaccine and fall ill. And the cost to vaccinate alone is expected to be between $600 million and $1 billion, and cash-strapped state governments are expected to pay that bill on their own.
In addition, Bill Foege is worried about public perception in the face of a real threat. If large numbers of people are vaccinated now, when a threat doesn't exist, and many fall ill or die, then the public may be resistant to the vaccine when a real outbreak occurs. That could be disastrous.
The speed with which the Bush administration is pushing the vaccination plan seems based on political necessity and not public health concerns. There is currently a safer vaccine being developed and tested in Europe that doesn't involve the use of live vaccinia. It will be about a year before that vaccine is made available here in the US, but the Bush administration is pushing ahead with the older, more dangerous vaccine anyway.
In part, it's to prove that the government is doing something about the threat of terrorism. It's also in response to pressure from vaccine manufacturers who want to sell their old stock before the new vaccine hits the market. In either case, cynical political opportunism or a drive for corporate profits, expediency should never trump sensible public health policy. Too many lives are at stake.
Sources for this article include:
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12/27/02, B3 "Only 4 Get Conn. Smallpox Vaccinations,"
Noreen Gillespie, Associated Press, 1/24/03 "Hospitals balk
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vaccination risks emphasized," Seattle Post-Intelligencer,
1/24/03, B4 "A person's Smallpox vaccine risky for others,"
Seattle Times, 1/19/03, B1 "Advisers Urge Slowdown in U.S.
Smallpox Plan," Maggie Fox, Reuters, 1/21/03 "Medical
Panel Has Doubts About Plan for Smallpox," Denise Grady,
The New York Times, 1/16/03 "Panel Recommends Slow Smallpox
Approach," Laura Meckler, Associated Press, 1/17/03.