Viewing by month: April 2013
April 2, 2013 | Posted By Bruce White, DO, JD

Last week, with the publication on March 19, 2013, of the Presidential Commission’s report titled Safeguarding Children: Pediatric Medical Countermeasure Research, the Commission demonstrated its unique value to the American people. The report came as an answer to a request from the Kathleen Sebelius, Secretary of the Department of Health and Human Services. Following are the first two paragraphs from the January 6, 2012, letter sent by Secretary Sebelius to Dr. Amy Gutmann, chair of the Presidential Commission for the Study of Bioethical Issues:

The U.S. Department of Health and Human Services is responsible for developing and stockpiling safe and effective medical countermeasures to protect the nation from bioterror attacks. While it has made significant progress toward this goal for adults, the development of appropriate medical countermeasures for children lags, in part due to challenges in collecting basic dose and immunogenicity studies in pediatric populations.

On October 28, 2011, the HHS’s National Biodefense Science Board (NBSB) released its report and recommendation on the “Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP).” The NBSB debated how best to obtain scientifically valid safety and immunogenicity data about AVA PEP for children, a complex issue with ethical, scientific, medical, legal, regulatory, and administrative challenges. In its recommendation, the NBSB concludes that it would be in the best interests of children to gather safety and immunogenicity data about AVA PEP in children prior to an anthrax event, rather than during a future crisis when the vaccine may be needed. The NBSB also recommends that such data be obtained only after the ethical considerations are adequately addressed and reviewed by an appropriate body.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.