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Last Updated

06 Jan 2003

Source: Rocky Mountain News, January 6, 2003

Expert: 'Not a safe vaccine'

Smallpox inoculation still too risky for public, doctor says

By Jim Erickson, Rocky Mountain News

President Bush shouldn't have offered the smallpox vaccine to the American public last month because it's still too risky, a leading authority on adverse reactions to the inoculation says.

"President Bush said that any civilian who wanted it could have it. I think that was a mistake, frankly," Dr. Vincent A. Fulginiti said Friday. He spoke at Children's Hospital in Denver.

"This is not a safe vaccine for the general public because of all the complications," Fulginiti said during an interview before his lecture. "This is not the measles vaccine."

Most U.S. physicians have never witnessed the rare but sometimes gruesome side effects the smallpox vaccine can trigger. And few have treated more of the severe complications than the 71-year-old Fulginiti.

In 1961, he joined renowned pediatrician Dr. Henry Kempe at Colorado General Hospital in Denver, now known as University of Colorado Hospital.

Kempe, who died in 1984, pioneered treatments for the vaccine's sometimes-fatal side effects. In the 1950s, he developed what is still the main defense against vaccine-induced disease: vaccinia immune globulin, which is made from the blood of recently vaccinated people.

In the 1960s, hundreds of children from across the country - and a few from as far away as Europe and South America - were sent to Denver for help.

"This was the place, and they were sent strictly because Henry and Vince Fulginiti were doing the research on treatments for those reactions," said Dr. Richard D. Krugman, dean of the University of Colorado medical school. Krugman worked with Kempe and Fulginiti as a resident in the 1960s.

The stricken infants often arrived on military aircraft because civilian airlines refused to take them, Fulginiti said.

At the time, smallpox vaccinations were mandatory in the United States, and infants usually received the inoculation eight to 12 months after birth.

The smallpox vaccine is made from a live, replicating virus called vaccinia. It helps the body develop immunity to the closely related smallpox virus.

But in rare cases, the vaccinia virus spreads from the shoulder inoculation site to other parts of the body. Life-threatening reactions can include an inflammation of the brain called postvaccinal encephalitis, and an uncontrollable and usually fatal flesh-devouring infection called progressive vaccinia.

Kempe and Fulginiti treated 23 children with progressive vaccinia at Colorado General in the 1960s. Only two of them survived, said Fulginiti, who retired last year and now lives in Arizona.

"It was disturbing to lose so many children," he said. "Henry was profoundly disturbed, so much so that he wanted vaccination stopped. But it took several years before people would listen to him."

At a meeting of the American Pediatric Society in Philadelphia in 1965, Kempe stood before his peers and said U.S. smallpox vaccinations should be halted because they killed more children than they protected.

A debate ensued, with Dr. Saul Krugman of New York University and several others firing verbal volleys back at Kempe.

"If we accept Dr. Kempe's proposal, we are likely to revert to the 1920 to 1930 prevalence of smallpox," said Krugman, according to a June 1965 article in Medical World News.

Kempe is best known to most Coloradans for his later studies of child neglect and abuse. He coined the term "battered child syndrome," and Denver's Kempe Children's Center is named for him.

In 1984, he was nominated for the Nobel Peace Prize by former Rep. Patricia Schroeder, a Colorado Democrat.

Today, the Centers for Disease Control and Prevention estimates that for every 1 million people vaccinated against smallpox for the first time, at least 1,000 will suffer serious but nonlife-threatening reactions; between 14 and 52 will experience potentially life-threatening reactions; and one or two will die.

On Dec. 13, President Bush announced that 500,000 military personnel will be vaccinated against smallpox immediately.

Those vaccinations will be followed by a voluntary program to inoculate about 450,000 doctors, nurses and emergency workers who would be the first to respond if terrorists use smallpox as a weapon against the United States.

Then the vaccine will be offered to as many as 10 million health care workers, police, firefighters, paramedics and other emergency workers.

Finally, the federal government would "work to accommodate" members of the public who insist on being inoculated, Bush said. But he stressed there is no evidence that a smallpox attack is imminent.

"If there's an attack, there's plenty of time to immunize the population," Fulginiti said. "So unless there's a real threat, I don't think civilians should be vaccinated."