FDA seeks public debate on vaccine test in toddlers
ASSOCIATED PRESS
WASHINGTON, Oct. 31 —
Researchers want to begin the first studies of the effects of a
risky smallpox vaccine on toddlers and preschoolers — a proposal
raising such thorny questions about safety and ethics that the
government is seeking public reaction before giving the OK.
After research oversight boards had mixed reactions to the proposal,
the FDA announced that for the next month it will accept public
comment on whether scientists should inoculate 40 2- to 5-year-olds
with smallpox vaccine.
AMONG
THE ISSUES: 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, 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’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.”
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.
WHY IS TESTING AN
ISSUE?
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.
Smallpox's
rise and fall
Time line of a scourge
1754-1767
British forces in North America distribute tainted
blankets to "disaffected tribes," marking first use of
smallpox as an intentional weapon.
1796
Edward Jenner demonstrates that cowpox inoculation can
guard against smallpox.
1967
World Health Organization launches global vaccination
campaign against smallpox.
1971
Smallpox's eradication leads U.S. to discontinue routine
vaccination.
1977
Last naturally occurring case of smallpox reported in
Somalia.
1980
WHO certifies that the world is free of naturally
occurring smallpox. Soviets begin to develop smallpox as a
bioweapon.
1982
Vaccine production is discontinued in the United States.
1990
U.S. military discontinues routine vaccinations.
Today
Smallpox vaccinations are generally limited to selected
lab workers and military personnel.
“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.
SPECIAL OVERSIGHT FOR
KIDS
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.
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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.”
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"
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