When you develop a vaccine for a common disease – the flu, for example – the disease that’s being vaccinated against is so widespread you generally don’t have long to wait to determine how effective the vaccine is. But what about a rare and deadly condition such as anthrax, particularly when it comes to children’s vaccines? The ethical considerations are complex and multi-layered.
President Obama’s Commission for the Study of Bioethical Issues recently released a report that concluded that the federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered. The report was the answer to a question posted last year by Health and Human Services Secretary Kathleen Sebelius, who asked the Commission to provide guidance on the potential for anthrax vaccine trials with children.
The questions of anthrax trials are sticky. Obviously, it’s impossible to expose participants to anthrax deliberately – the disease , which is caused by the bacterium Bacillus anthracis – is lethal and has only a limited response to antibiotics – so any vaccine trial could only be evaluated in the aftermath of a catastrophic event, such as a bio-terrorists releasing a strain of the bacteria in a large city. As a result, the vaccine program would be referred to as a “pre-event” trial.
Anthrax vaccines are available for at-risk adults – such as military personnel operating in war zones – but they are controversial. A number of military personal have objected to the mandatory nature of the vaccines, and some have alleged the vaccine is responsible for a number of disturbing side effects, including Gulf War Syndrome, though the allegations have never been proven.
“The safety of our children is paramount and we have to get this precisely right,” said Commission Chair Amy Gutmann, Ph.D. in the report. “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."
The report noted that a major ethical consideration in “pre-event” trials, in which testing occurs before an actual or imminent attack, is that children do not stand to benefit directly from participating in the study, and so risk must be kept very limited and small. In addition to recommending that pre-event trials with children not go forward in the absence of further testing on adults, the Bioethics Commission clarifies other rigorous conditions that must be met before such pediatric research may ethically proceed.
Edited by
Brooke Neuman
