Is it ethical to test the anthrax vaccine in children?

anthrax vaccine children trial ethics

A US presidential commission has given a tentative thumbs-up to the testing of the anthrax vaccine in children. The report released by the Presidential Commission for the Study of Bioethical Issues described the necessity of testing the vaccine on children, but also detailed strict guidelines for testing to keep children at minimal risk.

“The safety of our children is paramount, and we have to get this precisely right,” said Commission Chair Amy Gutmann, Ph.D., president of the University of Pennsylvania, in a press release. "The Bioethics Commission concludes that many significant steps would have to be taken, including additional minimal-risk research with adult volunteers, before pediatric anthrax vaccine trials prior to an attack should be considered.”

Anthrax vaccine testing in children has been called for because, in the event of a mass bioterrorist attack, a large proportion of the victims would be children. A thorny ethical issue is that not only would children not be able to fully understand the risks of participating in the study, but the children would also not gain any direct benefit from the research. As such, the panel announced that the risk to the children should be no more than minimal. It's thought that the proposed vaccine trial would start with children aged 18 and work its way down to 17- and 16-year olds.

It seems like the impossible ethical question. On the one hand, it seems important to test the vaccine in the immune system of children so that biodefense researchers can be sure that the vaccine is effective. On the other hand, questions have to be asked about the likelihood of a bioterrorist attack using anthrax and the effectiveness of using antibiotics instead. Critics of the testing would argue that it was unethical to use children in such a trial. The panel's response arose from “one of the most difficult ethical reviews a bioethics board has ever conducted,” said Gutmann.

You can hear more about research and development in biodefense vaccines by watching this video presentation delivered by Dr Michael Kurilla.

What do you think? You can join our discussion on LinkedIn or leave a comment below, I'd love to hear what you think.

If you're interested in hearing more about strategy and innovation in vaccines, you might like to consider attending the World Vaccine Congress and Expo 2013 on the 16-18 April 2013, Gaylord National Hotel and Convention Center, Washington DC. You can download the brochure here.

Comments 2

  1. Mary Tocco

    I believe that testing on children is completely unethical. Why not start with monkeys? Why do not test vaccines are large groups of primates before we ever introduce them into humans? I feel that the foundation of vaccinology is based on the wrong “Presupposition” that we can inject something into the human body and expect a proper immune reaction in the TH1 arm which is where it is supposed to be? Modern immunologists now agree that the theory of vaccinology is showing signs of failure and yet the business of vaccines continues. Here is a quote from an immunologist who wrote a book, Vaccine Illusions. She decided to research vaccines after having a baby and admitted that they do not learn much about vaccines when becoming an immunologist! Dr Tetyana Obukhanych, author of the book “Vaccine Illusion” has studied immunology in some of the world’s most prestigious medical institutions. She earned her PhD in Immunology at the Rockefeller University in New York and did postdoctoral training at Harvard Medical School, Boston, MA. and Stanford University in California. From her book, Vaccine Illusions: “Vaccination does not engage the genuine mechanism of immunity. Vaccination typically engages the immune response—that is, everything that immunologists would theoretically “want” to see being engaged in the immune system. But apparently this is not enough to confer robust protection that matches natural immunity. Our knowledge of the immune system is far from being complete. Three important factors have contributed to my gradual disillusionment with immunologic paradigms and their applications – vaccines. First, several significant inconsistencies within immunologic theory made me quite unsatisfied with its attempted explanation of immunity. Second, I observed how some seasoned immunologists would omit mentioning the outcome of crucial experiments to make their publication on new vaccine development strategies look very promising. This made me suspicious about the vaccine development process in general and eager to take a look at the other side of the vaccination debate.”“After years of doing research in immunology, observing scientific activities of my superiors, and analyzing vaccine issues, I realized that vaccination is one of the most deceptive inventions that science could ever convince the world to accept….“It is not immunity that we gain via vaccination but a puny surrogate of immunity. For this reason, vaccination at its core is neither a safe nor an effective method of disease prevention. Yet, immunologists have nothing better to offer because they can only go as far as their deeply rooted immunologic dogma allows them.”

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