In 2011 the U.S. government ran a war game to simulate how a San Francisco-sized city would cope with an anthrax attack by terrorists. The exercise found 1.7 million people under the age of 18 would need vaccinating, which raised a question--what is a safe dose for children?
This, in turn, brought up another question--is it ethical to find out? Clinical trials would be needed to determine how children responded to the vaccine. And with no immediate benefits for the kids enrolled in the study, the ethics of pediatric trials say there must be minimal risk to participants. The Presidential Commission for the Study of Bioethical Issues has weighed up how this thinking applies to a possible anthrax vaccine trial over the past year, and published its findings.
Its nearly 150-page report on the question of whether a trial can take place amounts to a tentative 'yes, but not yet.' Before giving its full approval the commission wants to see further research in adults to get a clear idea of risk. Dose-sparing studies are an option. "With additional safety data, the level of risk to young adults could be inferred with increased statistical confidence. Such an inference, in turn, would influence a possible minimal-risk design of a series of age-deescalating safety and immunogenicity studies," bioethics committee chair Amy Gutmann wrote in the New England Journal of Medicine.
The 'age-deescalating' trials would start in 18-year-olds, and then include younger and younger children as safety was shown in each age group. This approach has still drawn criticism though. Founder of the Alliance for Human Research Protection Vera Sharav told Reuters the trial would cause "moral harm for us as a nation and suffering for the children. They should have said, 'thou shalt not.'" On the other side of the debate, some fear what will happen if terrorists attack before an ethically acceptable trial is designed.
The decision now lies with Health and Human Services Secretary Kathleen Sebelius.
- here's Reuters' take
- read the NEJM op-ed
- check out the full report