Caution on child smallpox tests

The Philadelphia Inquirer ^ | Nov,1 2002 | By Lauran Neergaard

[Marie]

WASHINGTON - Researchers want to begin the first studies of the effects of a 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 approval.

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 will not benefit from the vaccine - unless a bioterrorist attacks with smallpox?

After research oversight boards had mixed reactions, the Food and Drug Administration announced yesterday 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.

"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 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 a vaccine again available, first to certain health-care workers and later to the general public.

It is 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 their eyes or 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.

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 potent shots to go around until new ones are made, scientists are studying whether 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.

[Marie]

Here's a way you can give your opinion to the FDA about these trials.

http://ohrp.osophs.dhhs.gov/dpanel/fr1031.pdf

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.

Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket number [Docket No. 02N-0466].

Received comments may be viewed on the FDA website at http://www/fda.gov/ohrms/dockets/dockets/02N0466.htm

For more information contact Leslie K. Ball, Office of Human Research

Protection 301-496-7005