To the amazement of many, the Presidential Commission for the Study of Bioethical Issues met this week in Miami to discuss whether to approve a program that would test the anthrax vaccine in children. The discussion centered around concerns that terrorists might try to kill thousands by weaponizing the deadly anthrax bacterium and whether a vaccine that would be effective in children would need to be tested on children.
Here are some facts to consider about the anthrax vaccine:
1) The US government has about 75 million doses of the anthrax vaccine worth $2 billion mostly sitting in civilian stockpiles expiring.
2) The vaccine is dangerous – one Government Accountability Office report said that 1-2% of recipients may develop illnesses resulting in disability or death.
3) The anthrax vaccine would protect no one in the event of an attack as it takes 5 doses and 40-45 days to become effective.
4) The anthrax vaccine has never been proven to be effective for any route of infection (inhaled, ingested or cutaneous) in humans and and a number of vaccinated monkeys, exposed at Fort Detrick, came down with the disease anyway. (Washington Post, July 18, 2002 page A1.)
5) If an anthrax attack occurred, antibiotics would be the treatment of choice.
6) Children will not benefit from an anthrax vaccine trial but might be seriously harmed rendering any such trial completely unethical.
7) Given that children would be put at risk but have zero benefit from an anthrax trial combined with the fact that children cannot give informed consent, it has always been considered unethical to test this vaccine on children. In fact Federal law protects children from such tests. According to the law, it must be determined that “the research presents no greater than minimal risk to the children” and “the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by available alternative approaches”1