Last month, the Presidential Commission for the Study of Bioethical Issues released a nuanced and thoughtful report recommending against studying the anthrax vaccine in children. I might have agreed -- why put any child at unnecessary risk? -- had I not spent a year co-chairing an Institute of Medicine report on protecting the public from a deadly anthrax attack.
Anthrax is considered the most likely threat for a bioterrorism attack because its hardy, microscopic spores are easily cultivated and make for a powerful weapon. Symptoms develop a few days after exposure, and once they do, the disease is usually fatal, and gruesomely so. (Death typically results from internal bleeding, pulmonary failure, and meningitis.) An exposed population also must be vaccinated to prevent the spores from reactivating and causing infection weeks after the original exposure.
Since the 2001 anthrax scare, when letters containing anthrax spores were mailed to media outlets and two U.S. senators, the government has gone to considerable lengths to improve our defenses, particularly in the event of a large-scale airborne attack. We have large stockpiles of drugs as well as an FDA-approved vaccine ready for deployment. And there have been numerous drills across the country to ensure we know how to respond -- and quickly.
But here is the rub. While the vaccine has long been approved and used in adults, it has never been studied in children. The President's Commission declined to permit anthrax vaccine research on children on the grounds that child participants have no prospect for direct benefit, since they had not been exposed to anthrax. This distinction is crucial in research regulation, since pediatric studies with "no direct benefit" face substantial barriers for approval. But this is a category error. Vaccines are preventive treatments, and vaccine research is preventive research. Such a study is not done on those who have been exposed to an agent, but on those who are at risk of exposure. (The exception would be in case of exposure during a natural disaster.) If the population in the study is at risk, there is potential benefit to them from receiving the vaccine.
Bioterrorism experts are a gloomy lot. They're highly-educated people, often with multiple advanced degrees, who spend their days pondering frightening worst-case scenarios. They take anthrax very seriously; many are already vaccinated. That's why a group of such experts, the National Biodefense Science Board, recommended studying the vaccine in children, pending ethics approval.
Here's how it could work: Query those who, based on their professional work, are highly informed about bioterrorism and who can meet a very high standard for informed consent. Then within this group, identify those who are parents and live in high-risk cities (there's a list). Ask them if they see a potential benefit for their children in vaccine trial participation. Based on a very informal sample of my acquaintances from the world of bioterrorism preparedness, all would strongly consider enrolling their child in an anthrax vaccine trial -- based on potential benefit. Even with requiring rigorous parental informed consent, child assent, limiting to children in high-risk cities and starting with the oldest, I am betting you'd still have enough children to complete a solid study.
It is important to protect children from the risks of research. It is even more important to avoid exposing millions of children to untested vaccine in the ultimate clinical study -- one that unfolds during a live public health disaster.
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