A Security Take on Safeguarding Children: Pediatric Medical Countermeasure Research

Abstract

Two years ago I joined a group of experts across federal agencies to discuss the findings of an exercise dubbed “Dark Zephyr.” The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) developed this exercise to test the US government's capacity to deal with the aftermath of a large-scale attack involving a biological weapon. This particular simulation examined what would happen during the mass distribution of Bacillus anthracis spores, the causative agent of the disease anthrax. The projected outcomes, although alarming, did not surprise those who worked on issues pertaining to weapons of mass destruction (WMD). Nearly 8 million people could be exposed if a mass anthrax spore release took place in a city such as San Francisco, and almost a quarter of those exposed would be children. Many of those infected would die if left untreated. Despite a stressful situation rife with uncertainty, local, state, and federal agencies would have to provide an integrated response involving coordinated communication strategies, predictive plume modeling, forensics, intelligence collection, and distribution of medical products from the Strategic National Stockpile (SNS) through points of distribution. Dark Zephyr deliberately focused on the distribution of medical countermeasures (MCMs), including vaccine. Protocols developed by the US Centers for Disease Control and Prevention (CDC) to treat exposure to B. anthracis include the use of anthrax vaccine adsorbed (AVA) for both adults and children. Accordingly, much of the Dark Zephyr analysis focused on the amount of vaccine in the SNS, the speed with which vaccine could be delivered, and public acceptance of the MCM. One of the issues raised during the discussion was the absence of any definitive evidence regarding AVA use with children. Although vaccine administration is included in treatment protocols for children, did we know if it was effective? Did we know if the dosing was correct? Did we know whether it would even be accepted by parents and caregivers? These are difficult questions with no easy answers—answers that we need before we can be confident that preparedness and response plans for a mass anthrax distribution event would adequately provide for the care of children. Beyond the matter of MCMs for anthrax loomed the even larger question of how to obtain the best scientific evidence for pediatric treatment in the face of WMD threats more generally, particularly those cases where no therapy yet exists.