Smallpox Vaccine Test Results from Baylor College of Medicine

December 13, 2002

- Milo

Dec. 4, 2002, 11:47PM

Smallpox vaccine's side effects raise panic

Trials report fever, swelling, itchiness

By CECI CONNOLLY Washington Post

http://www.chron.com/cs/CDA/printstory.hts/health/1689807

As physical specimens, the Baylor College of Medicine students in Houston were fit and healthy, the "creme de la creme," in the words of researcher Kathy Edwards. Yet when she inoculated them with smallpox vaccine, arms swelled, temperatures spiked and panic spread. It was the same at clinics in Iowa, Tennessee and California. Of 200 young adults who received the vaccine as part of a recent government study, one-third missed at least one day of work or school, 75 people had high fevers, and several were put on antibiotics because physicians worried that their blisters signaled a serious bacterial infection. Even for experts such as Edwards, the Vanderbilt University physician overseeing the study, the side effects were startling. "I can read all day about it, but seeing it is quite impressive," she said. "The reactions we saw were really quite remarkable." President Bush is poised to announce plans, perhaps as early as this week, to resume vaccinating Americans against smallpox as part of a massive push to protect the nation from a biological assault. As he weighs the decision, researchers are becoming reacquainted with the unpleasant -- often severe -- complications of the vaccine itself. The experiences in a half dozen clinical trials offer an early look at what military personnel, hospital workers and other emergency workers will likely encounter if Bush adopts the recommendations of his top health advisers to vaccinate up to 11 million people in the coming months. What is disconcerting, say the people participating in the clinical trials, is that when it comes to smallpox vaccination, what had once been considered ordinary is rather extraordinary by today's standards. "I just wanted to go to bed for a day or two there," said Alison Francis, a New York University graduate student who received the vaccine. Francis, 24, said she felt tired and achy after getting her shot. Her arm was heavy, warm to the touch and terribly itchy. "I thought, `Can you just chop off my arm?' " Once among the deadliest scourges on Earth, smallpox was declared eradicated worldwide in 1979. But growing hostilities with Iraq, Osama bin Laden and other terrorists have renewed fears that the virus could be used as a potent, stealthy weapon. Vaccination protects against the disease, but it is risky. For every 1 million vaccinated, between 15 and 52 people will suffer life-threatening consequences such as brain inflammation, and one or two will die. Federal health officials have proposed resuming vaccination in stages, beginning with up to 500,000 hospital workers most likely to see an initial case. Later, as many as 10 million police, fire and medical personnel would be offered vaccine. The Pentagon hopes to vaccinate 500,000 soldiers. Over the past year, federal researchers have been testing the 40-year-old vaccine for its safety and potency. None of the 1,500 volunteers have died or been seriously injured by the vaccine. Unlike most modern vaccines, the smallpox vaccine is administered by 15 quick pricks that literally "establish an infection in your skin," said Julie Gerberding, director of the Centers for Disease Control and Prevention in Atlanta. Within three to four days, a red itchy bump develops, followed by a larger blister filled with pus. In the second week, the blister dries and turns into a scab that usually falls off in the third week. During the three weeks, many people experience flulike symptoms -- aches, fever, rash, swelling, lethargy -- and terrible itchiness.