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Experts Split on Anthrax Vaccine Tests on Children
Potential tests on children of a new anthrax vaccine are drawing criticism from a vaccine safety advocate, the Kansas City Star reported today (see GSN, June 17). “There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized,” said Barbara Loe Fisher of the National Vaccine Information Center. “The benefits are zero and risk is quite high.” However, pediatricians knowledgeable in bioterrorism issues argue that children must be included in the tests, the Star reported. “Considering that in a worst-case scenario, this vaccine would have to be used in an emergency over a very short period of time, we would be in a bad position medically and ethically if it were not tested beforehand,” said University of Pennsylvania pediatrics professor Stanley Plotkin. In current testing, 350 adults are being injected with either the licensed BioPort vaccine or the experimental treatment being developed by VaxGen, to determine if the new drug is more effective. Children would not be included in tests until the safety of the new vaccine is demonstrated, according to a statement from the National Institute of Child Health and Human Development, a division of the National Institutes of Health. Institute spokesman Robert Bock said tests on 100 first- and second-graders would occur if the vaccine is shown to be safe in adults. Meryl Nass, an internist in Maine who treated military personnel for adverse reactions to BioPort’s vaccine, said she doubts the new vaccine would prove less harmful. “There is no good reason to expect that (the experimental) vaccine will be any safer than the older one,” Nass said. Federal rules dictate that any research conducted on children can only put them at “minimal risk.” If the risk is greater, the research must have direct benefit to the children or increase understanding of a disease that affects children. Parents or guardians must be told of potential risks before testing begins. “As long as effective safeguards are in place and families and the children understand the risk, I think that this is the right thing to do,” said Julian McMillan, a pediatrics professor at Johns Hopkins University and a member of the American Academy of Pediatrics Committee on Infectious Diseases (David Goldstein, Kansas City Star, June 27).
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