Global Security Newswire

A U.S. soldier receives the anthrax vaccine in 2004. The U.S. Health and Human Services Department last month asked a special presidential panel to weigh ethical issues involved in the potential development of biological agent countermeasures for children (AP Photo/Christopher Berkey).

A special presidential commission has accepted a request from the Health and Human Services Department to study the ethical implications of developing biological agent countermeasures for minors and will begin examination of the matter in the spring, Slate reported on Monday (Caitlin Mac Neal, Slate, Feb. 6; see GSN, Oct. 31, 2011).

Presidential Commission for the Study of Bioethical Issues Chairwoman Amy Gutmann last week in San Francisco said the panel would accept a request made in early January by HHS Secretary Kathleen Sebelius, according to an official commission blog post.

"The safety of our children is paramount, and it is vital that we thoroughly address any and all ethical considerations relative to having adequate and available safety and immunogenicity data on our medical countermeasures to protect them before, during and after an event," Sebelius said in her written request to the commission.

The department's National Biodefense Science Board last fall concluded that additional assessments should be pursued before any testing of anthrax countermeasures on children is begun.

Anthrax is considered a likely candidate for a feared bioterrorism attack. The only Food and Drug Administration-approved vaccine for anthrax has to date been tried solely on adults, leaving a deficit of understanding on the countermeasure's effectiveness on children, appropriate dosage levels and any possible side effects (see GSN, Oct. 25, 2011). 

Critics of testing the vaccine on children contend there is not a high enough probability of a naturally occurring outbreak or an attack to justify testing the vaccine on minors if there is a chance it could cause negative health effects. Some adults who have received the vaccine have reported experiencing muscle tenderness, headaches, and tenderness near the site of the inoculation. More rarely, severe allergic reactions have been reported.

Another ethical concern is that children cannot decide for themselves whether to be tested; parental consent must be given. Sebelius has asked the commission to study "how best to obtain clinical data on medical countermeasures in children" (John Donnelly, Presidential Commission for the Study of Bioethical Issues, Feb. 2).

Separately, U.S. epidemiologist Donald Henderson told the Huffington Post  he does not believe the United States is equipped to respond to a large-scale biological weapons attack, despite more than 10 years of considerable effort at the federal, state and local levels (see GSN, Dec. 15, 2011).

"I've kept quiet about this for a long time, but I'm deeply concerned," said Henderson,  who headed the international program to wipe out smallpox and formerly managed the HHS Public Health Preparedness Office.