Feds seek public input on vaccine for children.

2002 DEC 4 - (NewsRx.com & NewsRx.net) -- The U.S. government is seeking public input before it decides whether to let a few dozen toddlers and preschoolers be vaccinated against smallpox, a study to test the best children's vaccine dose but one raising thorny questions about safety and ethics.

The vaccine is made of a live virus called vaccinia that can cause its own infections until the injection site scabs over, so researchers plan to keep inoculated children out of day care or school for a month. But still there is a chance that youngsters could tear off their bandages and put relatives, playmates or others at risk.

There also is the question of whether it is ethical to test in healthy children a vaccine that could cause a life-threatening reaction when the children probably won't benefit from it - unless a bioterrorist attacks with smallpox.

After research oversight boards reached mixed conclusions on these issues, the Food and Drug Administration announced that during November 2002 it would accept public comment on whether the University of California, Los Angeles, and Cincinnati Children's Hospital should inoculate 40 2-to-5-year-olds with smallpox vaccine. They would be the first children to get the shots since routine vaccination ended in 1972.

It's highly unusual for the FDA to seek public opinion on research.

"It is a very challenging issue because there is no smallpox circulating right now," said Dr. Karen Midthun, the FDA's head of vaccine research. "There is great concern that there be a lot of safeguards for studies being conducted in children."

"This is an unusual time, it's an unusual need and I think the risks are not totally insignificant," said Dr. Joel Ward of UCLA, the lead researcher. "So I think this extra care is appropriate."