http://www.cbsnews.com/stories/2002/10/24/health/printable526871.shtml
Smallpox, Ethics And Children
WASHINGTON, Nov. 1, 2002
Researchers want to begin the first
studies of the effects of a risky smallpox vaccine on toddlers and preschoolers
- a proposal that is 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 will youngsters
tear off their bandages and put relatives, playmates or others at risk?
And is it ethical to test in healthy children a vaccine that could cause a
life-threatening reaction when they probably won't benefit from it - unless a
bioterrorist attacks with smallpox?
After research oversight boards had mixed reactions to the proposal, the Food
and Drug Administration announced Thursday that for the next month it will
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 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."
Although wild smallpox was eradicated in the 1970s, officials fear that
laboratory samples might have fallen into terrorists' hands. Faced with that
uncertainty, the Bush administration is preparing to make vaccine again
available, first to certain health care workers and later to the general public.
It's a difficult decision because of the vaccine's risks: Based on studies from
the 1960s, 15 of every 1 million people vaccinated will suffer life-threatening
reactions, and one or two of them will die.
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 be killed by the virus.
Children once routinely got the smallpox shot, so why is new testing an issue?
The vaccine has been kept frozen for 30 years. To ensure there are enough shots
to go around until new ones are made, scientists are studying if diluted doses
work. Recent studies in adults suggested they do. The planned pediatric study,
sponsored by the National Institutes of Health, would test those weaker doses in
young children, whose immune systems work differently than adults' do.
"I would certainly want these trials to be conducted before I would want my
child to be vaccinated," said Dr. Julia McMillan of Johns Hopkins University, a
spokeswoman for the American Academy of Pediatrics. The academy has urged the
government since last spring to do child studies before allowing broad access to
the vaccine.
It's not just for the child's benefit, she said: The last time children were
inoculated, their relatives and playmates were, too, so no one knows how kids
might spread vaccinia through today's unvaccinated population.
Federal regulations require special oversight for research that poses more than
a minimal risk to a child who won't get a significant benefit. Oversight panels
and independent experts consulted by the government have said that is the case
here, because children's risk of getting smallpox is so small.
Still, most of those experts said the research should be allowed because it
could benefit society. They did suggest changes - such as limiting inoculations
to the children of people enrolled in adult smallpox vaccine studies, because
those parents may better understand the risks. Fully explaining the risks to
parents is crucial, many said.
"Many parents incorrectly believe that the risk of potential exposure (to
smallpox) is very high," Johns Hopkins professor Dr. Neal Halsey wrote the FDA.
Under current study plans, no child would be inoculated if the child or a family
member has immune problems or skin diseases such as eczema that raise the risk
of vaccine complications. Children who live with a pregnant woman or infant
would also be ineligible, because babies under age 1 are at significantly higher
risk of a vaccine-caused brain infection.
Inoculation sites would be covered with a special bandage that in adult studies
proved very effective at preventing spread of the vaccine's virus. While
children are known to rip off bandages, Midthun said this one is extra sticky,
"very, very hard to get off."
By Lauran Neergaard © MMII The
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