Kids Low in Smallpox Vaccine Priority

WASHINGTON - For decades, the vast majority of smallpox inoculations were delivered to children, but in the new vaccination program now under way, children won't qualify absent a bioterror attack, federal officials said.

Ethical and safety concerns bar children from clinical trials being conducted now, meaning the vaccine cannot be licensed for them, said Dr. Anthony Fauci, who oversees vaccine development and bioterrorism programs at the National Institutes of Health.

"If Mom comes up to one of the local and state health officials and says, `I want vaccine for my 5-year-old,' currently there doesn't appear to be a mechanism for them to get it," Fauci said Saturday.

Adults will soon have access to the vaccine, although it is not being recommended for the general public. Smallpox was eradicated in the 1970s and, while experts fear that terrorists or hostile nations could unleash it in an act of bioterrorism, President Bush said Friday there is no imminent threat.

The government is recommending inoculations for about 10.5 million people on smallpox response teams, hospital emergency rooms, other health care jobs, police, fire and other emergency personnel. Those shots are likely to begin in late January.

Bush also ordered vaccinations for some half-million military personnel in high-risk parts of the world.

In the civilian world, vaccinations are voluntary, and health officials worry that people may not fully understand the risks. In the coming week, the Centers for Disease Control and Prevention plans a one-hour program for people being offered the vaccine, with detailed information about benefits, risks and details about how to reduce the chances of side effects.

Polls suggest most people would want the vaccine. But in CDC-sponsored focus groups now under way, interest dropped considerably after people were told of the risks, said Dr. Julie Gerberding, CDC director.

Based on studies from the 1960s, about 15 people out of every million being vaccinated for the first time will face life-threatening side effects, and one or two will die.

The vaccine is made of a live virus called vaccinia that can cause its own infections until the injection site scabs over. It poses a particular risk for children, who could tear off their bandages and put relatives, playmates or others at risk.

A vaccinated person can spread the vaccine's virus by touching the injection site, then touching the eyes, mouth or someone else. If the virus spread to the eye, for instance, it could cause blindness. Someone with a weak immune system, such as an AIDS patient, could die.

Because of these risks, the vaccine is only being recommended for workers in special fields. Still, Bush concluded he couldn't keep the vaccine from those who insist on it.

Those people can enroll in clinical trials now under way, and by spring or summer, the government plans to create an alternate program that would reach people without access to a trial.

By 2004, when enough licensed vaccine becomes available, it will be relatively straightforward for adults to get inoculated, although it still would not be recommended.

If there is a smallpox attack, however, officials are likely to order mass vaccination for adults and children and immediate shots for anyone exposed to the disease.

Absent that, it's not likely to be available to children anytime soon.

Researchers had hoped to enroll a few dozen toddlers in a clinical trial aimed at testing whether diluted vaccine is as effective as its full-strength dose. But research oversight boards at universities where the research was to take place had concerns about ethics and safety and asked the Food and Drug Administration for advice.

The FDA in turn took the unusual move of seeking public comment on the issue. Those comments are back and the "vast majority" said kids should be barred from the research, Fauci said.

"They really didn't think the risk was worth it for the children," he said.

Federal regulations require special oversight for research that poses more than a minimal risk to a child who won't get a significant benefit. That's the case here, experts believe, because there's such as small risk that any child would actually be exposed to smallpox.

Given the reaction to date, Fauci said, it's unlikely children will be let into any of the smallpox studies. That includes a major clinical study vaccine purchased to cover the entire country should it be necessary. Without clinical trials, the vaccine cannot be licensed for kids.

He added that it's doubtful that the government would let doctors give the vaccine to children if it's not licensed for them, even though that routinely occurs with other medications.

It's ironic given that, before routine vaccinations were halted in 1972, the vast majority of people given the vaccine were under age 5, Fauci said.

"The current restrictions on clinical trials don't necessarily reflect the restrictions that one had decades and decades ago," he said. "It's much more stringent."

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On the Net: Government smallpox information: http://www.smallpox.gov.

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