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HEALTH & SCIENCEPrudent to test smallpox vaccine in kids?Naysayers worry about the safety of even the diluted version on today's children; proponents say testing is warranted before widespread vaccination is deemed necessary.By Susan J. Landers, AMNews staff. Dec. 2, 2002. Washington -- The Food and Drug Administration sought public opinion on whether to proceed with a trial to vaccinate young children with the smallpox vaccine and the public responded. Within a few days of the FDA's Oct. 31 notice in the Federal Register, hundreds of people -- physicians, mothers, fathers and preschool operators among them -- voiced opinions. Many implore the FDA not to test the vaccine, which is known to have serious side effects, on children. "Children's bodies and minds are still fragile and growing," writes one woman. "Please do not place young children in jeopardy by testing this vaccine on them." But others offer a different opinion: "Government should proceed with these tests. Smallpox vaccines should be made available to everyone." The FDA is proposing to test the vaccine on 40 children ages 2 to 5, a population that had routinely received the smallpox vaccine until it was discontinued in the early 1970s. The trial would test the safety and immune response to the smallpox vaccine, Dryvax, used at full strength and also diluted at a one-to-five ratio. Although he didn't weigh in with an opinion to the FDA, Samuel Katz, MD, professor of pediatrics at Duke University, Durham, N.D., favors proceeding with the trial. "I think it's very appropriate that any new vaccines that will be licensed for widespread use be tested on children." Children may respond differently than adults as they might to any other pharmaceutical product, he said. Even though the vaccine is the same one used 30 years ago, the diluent used to prepare the dry vaccine is different, Dr. Katz pointed out. The trial would also include a more diluted form of the vaccine, making it an agent that should be tested in children to determine whether it causes any unusual reactions and to find out if it produces the appropriate response. The diluted version has already been tested in adults and found to be safe and to have produced the desired result -- a raised blister that scabs over. [...] Full text of AMNews content is available to AMA members and paid subscribers.
Copyright 2002 American Medical Association. All rights reserved.
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