Smallpox vaccination effort by feds does not include children

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.

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 children 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 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 children.

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.

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.