BIOETHICS PANEL RECOMMENDS FURTHER TESTING BEFORE INITIATING ANTHRAX VACCINE TRIAL ON CHILDREN.

Emergent BioSolutions Inc., has recently announced that it will begin Phase II of its clinical trials for NuThrax, a new vaccine against Anthrax infection.

The federal government however, is now saying that testing  of the vaccine on children must wait until other steps are taken.  In the words of Amy Gutmann, chair of the Presidential Commission for the Study of Bioethical Issues, "the trial would not be ethical if conducted today."

K. Sibelius, the head of Health and Human Services has ordered a review of the clinical trials, after some have questioned it as unethical.  

The objection raised against the clinical trials on children is that the risks of the trials could be significant, and when weighed against the possibility of an attack, the risks of adverse reaction are not commensurate with the degree of risk of an eventual attack.  

Although Anthrax is still considered one of the biological threats that could befall our nation, the attack might never occur.  

But Daniel Fagbuyi, of the Children's National Medical Center, who is behind the push to begin the clinical trials on children, has asserted that they just 'want to make sure we're taking care of the kids."

But the questions raised are pertinent.  Do we really know what the reaction to the vaccine might be? And, more importantly, there is not enough information on what the children's immune system reactions would be.  And that is an important question.  

The Commission then laid out a plan for the implementation of  a multiple step approach that must be taken before any trial can be started.

One of the most important of these steps is to ascertain that the risk to the inoculated child is low enough that it warrants the trial. 

Another suggestion is to try the vaccine on teenagers to see what their reaction is, as a step down program before inoculating small children.  

Those pushing for the testing however, are arguing that if there is an attack, that mothers will want to know why the testing was not begun earlier. 

The Department of Health and Human Services will be the agency to issue the final decision on the testing, but only after reviewing the commissioner's report.

Source: NPR 3.19.13