E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

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"Protecting the health and informed consent rights of children since 1982."

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[Federal Register/Vol. 67, No.211 10/31/02, Pgs 66403-04]

The Department of Health and Human Services and the Food and Drug Administration are soliciting public review and comment on a proposed research protocol entitled "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Response of Dryvax Administered to Children 2 to 5 Years of Age."

In particular, comments are solicited on the following questions: (1) What are the potential benefits of the research, if any, to the subjects and to children in general; (2) what are the types and degrees of risk this research presents to the subjects; (3) are the risks to the subjects reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result; and (4) does the research present a resonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children?

To be considered, written or electronic comments on the proposed research must be received on or before 4:30 p.m. December 2, 2002.

Submit written comments to the Dockets Management Branch (HFA-305), Docket Number 02N-0466, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

For more information contact Leslie K. Ball, Office of Human Research Protection 301-496-7005

Government considers when smallpox vaccine study should begin for children Fri Nov 1, 2:48 AM ET By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - The 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.

The Food and Drug Administration (news - web sites) 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. The Bush administration is preparing to make vaccine available again, first to certain health care workers and later to the general public.

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.

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 still-potent shots to go around until new ones are made, scientists are studying whether diluted doses work. Recent studies in adults suggest they do. The planned pediatric study, sponsored by the National Institutes of Health (news - web sites), would test those weaker doses in young children, whose immune systems work differently than adults.

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