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President's Bioethics Commission releases report on pediatric medical countermeasure research
Date:3/18/2013

ponse 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.

After the 2011 bioterrorism exercise, the National Biodefense Science Board (NBSB) recommended that the U.S. government conduct a study to test the safety and effectiveness ("immunogenicity") of AVA in children before an anthrax attack occurs, contingent upon a review of the ethical issues. Secretary Sebelius called on the Bioethics Commission for a thorough ethical review.

"The Bioethics Commission recognizes both the federal government's fundamental duty to protect individual children from undue risk during research and its obligation to protect all children as far as ethically and practically possible during an emergency by being prepared," said Daniel Sulmasy, M.D., Ph.D., Member of the Bioethics Commission.

Ethical Considerations and Recommendations:

Research with children is ethically distinct from other research, especially when the research in question promises
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Contact: Hillary Wicai Viers
hillary.viers@bioethics.gov
202-233-3960
Presidential Commission for the Study of Bioethical Issues
Source:Eurekalert

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