On one side: Does enrolling children in an anthrax vaccine trial put them at risk?

On the other: If there are no trials, does that put all children at risk in the event of an anthrax attack?

The Presidential Commission for the Study of Bioethical Issues today heard several medical and ethical experts address the question whether the Commission should recommend an anthrax vaccine trial in case of a widespread anthrax release.

“How do we balance … exposing children to a potential risk (in taking the vaccine) against the uncertain benefit in the future?” said Holly Taylor, M.P.H, Ph.D., Assistant Professor at Johns Hopkins’ Department of Health Policy and Management. “There needs to be a justification … if you are to go forward with a trial.”

Michael R. Anderson, M.D., a member and Fellow of the American Academy of Pediatrics, said he believed the risk of inaction was great. “As a scientist and as a pediatrician, I look at the data from the military: they have given millions of doses (to adults) with excellent safety data. We have to figure out a cogent and safe way to figure out how to get the data with children.”

In January, Health and Human Services Secretary Kathleen Sebelius charged the Commission for ethical advice on the development of medical countermeasures for children. Her task was prompted by the question of finding out whether an anthrax vaccine was safe to give children. The National Biodefense Science Board had recommended doing the test, but only after ethical considerations were reviewed.

Under questioning from the Commission, the experts today estimated that a short trial of roughly 300 children would be needed to get an early sense at whether the vaccine was safe at specific doses to specific age groups of children. Those short trials, they said, might be followed by a broader safety study of around 1,000 children.

After three panel discussions and during a roundtable round-up, Commission member Raju Kucherlapati, Ph.D., the Paul C. Cabot Professor in the Harvard Medical School Department of Genetics, asked each of them whether they would vote to allow the anthrax trials for children to go ahead.

The vote: four no, three yes, and one who wouldn’t say.

Several said they did not have enough facts to support the trial. And some said the lack of knowledge meant that a trial was necessary.

“I want to know more about the relevant facts,” David DeGrazia, Ph.D., Professor of Philosophy at George Washington University, saying he wouldn’t support it yet.

Anderson, who supports the trial, said the lack of facts would hurt a future response: “If God forbid, D.C. is dusted today (with anthrax), we (adults) have .5 milligrams (of the vaccine) go into our arms. The six-year-old down at the day care center we have no idea what to give.”

Earlier, in one of the panel discussions, Dr. Lisa Kaplowitz from the Office of the Assistant Secretary for Preparedness and Response at HHS said the risks involved in a public health emergency go well beyond the likelihood of an event.

While there are clear ethical considerations related to the clinical testing of countermeasures that may never be needed—since it is impossible to know with certainty the likelihood of a specific event actually occurring—there is also a risk related to delays in action, she said.

For example, during a public health emergency, the goal is to “limit the chaos” and mobilize quickly to get treatments to a large number of people in a short period of time, Kaplowitz explained. Delays can result in illness and death.

Taking up the discussion of risks, Taylor urged the Commission to consider the consequences of not conducting trials for medical countermeasures.