The chair of the Presidential Commission for the Study of Bioethical Issues announced today the panel has agreed to a US administration request to study ethical questions around safe and effective countermeasures for children following a bioterror attack.
Chair Dr. Amy Gutmann, speaking at a Commission session in San Francisco where the panel is discussing issues related to genetics and neuroethics, said that the panel will start to look at the issue later in the year, starting in a May meeting.
On Jan. 6, Health and Human Services Secretary Kathleen Sebelius asked the Commission for ethical advice on conducting clinical trials to develop medical countermeasures for the protection of children in the event of an attack.
“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 wrote in a letter addressed to Gutmann as Commission chair.
Gutmann said in response today: “This issue gained significant public interest last fall when another Federal advisory committee recommended pediatric testing of the anthrax vaccine. We have been asked by Secretary Sebelius to look in-depth at the ethical issues surrounding” countermeasures to protect children.
The issue arose following a simulation of an anthrax attack in San Francisco to test whether emergency responders were prepared for the aftermath of such a crisis. One of the conclusions from the simulation was that the anthrax vaccine had never been tested in children, raising questions about whether health authorities should administer it to them following an attack.
The HHS National Biodefense Science Board, a federal advisory panel on issues related to bioterrorism and biodefense, recommended in October that bioethicists should examine issues surrounding effective countermeasures to protect children. Sebelius then turned to the Commission.
One of the sensitivities around testing the vaccine in children is that children cannot give informed consent on their own. Sebelius asked the Commission to look at the issue broadly, examining “how best to obtain clinical data on medical countermeasures in children.”
There was no discussion around the issue at today’s meeting.