United Press International - December 13, 2002
Steve Mitchell, UPI Medical Correspondent

"This is one of our more risky vaccines (so) we want to make sure it's done safely," said Georges Benjamin, executive director of the American Public Health Association in Washington. "We need to broadly educate the public (and) make people fully understand the risks and benefits of taking the vaccine," he said.

Bush's plan calls for making the vaccine mandatory for U.S. military personnel in risky areas around the world and voluntary for doctors and nurses who could be the first to encounter victims of a smallpox terrorist attack. This would include about 1 million people initially.

Most who receive the vaccine will develop a wound at the site of the injection as well as a large, swollen red arm, Benjamin said. Fevers and flu-like illness are also side effects of the vaccine.

But a small percentage of those inoculated will suffer very serious complications, including inflammation of the brain and spinal cord, a widespread skin rash, blindness and death.

Although these are dangerous side effects, they must be balanced against the lethality of the smallpox virus itself, which kills about 30 percent of those it infects and leaves most who survive horribly disfigured, Benjamin said. There is no treatment for smallpox once a person has been infected.

"The risks are low overall," he said. "What concerns us is the fact that (as a population) we are immunologically different than we were when we last used this vaccine" in 1972.

This means certain groups of people are at particular risk of death and the more severe side effects of the vaccine. This includes people who have ever had a skin condition called eczema, those with HIV or AIDS, people on chemotherapy for cancer, people who have had organ transplants and are on drugs that suppress their immune systems and people on high-dose steroids for arthritis. Children less than 12 months old should not be vaccinated nor should nursing or pregnant women due to the threat to their baby.

There are medical treatments for treating the severe reactions, including a compound called vaccinia immune globulin and an antiviral drug called cidofovir, Benjamin said. He noted that there's one account of a soldier, who did not know he was HIV positive, developing a life-threatening complication after receiving the smallpox vaccine years ago. He was treated with the vaccinia immune globulin and this helped him recover, Benjamin said.

Although people with cancer, arthritis and organ transplants are unlikely to be in the military or active healthcare workers, they could have some of the other risk factors such as eczema, pregnancy and unknown HIV status, said Kathryn Edwards, a professor of pediatrics at Vanderbilt University who is conducting studies on the safety of the smallpox vaccine.

"If they have a history of one of these things, they have to take this seriously," Edwards said. "If there are situations where they are at risk, they need to not take the vaccine."

Another risk is shedding, Benjamin said. Although the virus used in the vaccine is different from the smallpox virus and cannot give you smallpox, it can shed from the site of the injection and cause local reactions in other parts of the recipient's body or cause problems in other people. Individuals have to make sure they keep the injection site covered with a bandage and make sure they don't scratch it and then touch another of their body because it could cause a local reaction, he said. This is particularly serious if it occurs around the eye because it could cause blindness, he added.

Another concern is genetic defects that cause deficiencies in the immune system, said Jonathan Goldsmith, medical director of the Immune Deficiency Foundation. Some people who suffer from this affliction are unaware of it, he said. So his group urges that authorities develop a way to screen people at the time of vaccination so that people with this condition do not receive the vaccine. "By asking a few questions, you may be able to screen these people out," he said. These include asking if the person has had a lot of infections that required antibiotics or if they have a family history of somebody with an immune deficiency problem.

Although most military personnel will not have this immune deficiency condition, "our concern would be about their dependents and family members" who might have it because they could be at risk of developing severe side effects from the vaccine if they come into contact with a person who was recently immunized and is still shedding, Goldsmith said.

Since a military strike against Iraq could be imminent, it is "better to vaccinate the troops sooner rather than later so they can get over it," said Charles Pena, senior defense policy analyst with the Washington-based think tank the Cato Institute. "You don't want to do this the day before you launch an operation. You want to give the troops a reasonable time to recover."

Pena noted that deciding not to offer the vaccine to the general population leaves the U.S. vulnerable to a bioterrorist attack using smallpox. "That means we have to accept if there is an attack people will die who might not have died had they been able to receive a vaccination," he said.
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