In a report released today, 19-Mar-2013, the Presidential Commission for the Study of Bioethical Issues concluded that the federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered. The Bioethics Commission was responding to a request from Health and Human Services Secretary Kathleen Sebelius who last year asked the members to study the question of anthrax vaccine trials with children after receiving a recommendation from another federal committee that such research be initiated, pending ethical review.
“The safety of our children is paramount and we have to get this precisely right,” said Commission Chair Amy Gutmann, Ph.D. “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.
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.
“Out of respect for every individual, our nation must protect children enrolled in research studies while also doing its best to develop the knowledge needed to save children’s lives during a possible emergency,” Gutmann said.
In the report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Bioethics Commission also more generally considered the ethics of research on pediatric medical countermeasures (MCM), the catchall term for the use of federally-regulated drugs and products in response to chemical, biological, radiological, and nuclear attacks.
Background:
In 2011, the U.S. government conducted a bioterrorism preparedness exercise to study the likely results of a large-scale release of weaponized anthrax spores in a city such as San Francisco. The casualty estimates were staggering: almost 8 million citizens would be affected, nearly a quarter of them children.
If such an event were to occur, current federal plans call for immediate distribution of antibiotics proven effective in treating anthrax infections, and a follow-up widespread vaccination program using Anthrax Vaccine Adsorbed (AVA). Vaccination is believed necessary because anthrax spores would likely continue to pose a threat of infection long after the initial release had taken place. AVA administration is challenging, however, because there is no definitive understanding of its effect in children despite having been in commercial production for more than four decades and having been safely administered to more than a million adults in the military.
