The threat of bioterrorism is terrifying thought, and the US government is set on minimizing any risk. But should they go as far as testing a potent anthrax vaccine on young children? The Presidential Commission for the Study of Bioethical Issues (PCSBI) has considered the question, and told the government to precede with caution.
In a new report the commission recommends the vaccine be shown to be of minimal risk to children before testing proceeds. The head of the commission, Amy Guttmann, defined minimal risk by comparing it to a routine medical check-up: it should pose “absolutely no substantial risk or threat to the child.”
To satisfy this criterion, researchers need to demonstrate with data from young adults (18 to 20 years old) that the risks will be minimal for older teenagers. They will likely look at safety data from the young adults who are among the more than 1 million US military personnel to receive the 4-decade-old anthrax vaccine. If it appears safe, they can test the vaccine on older children (say, 16- to 17-year-olds) and then on progressively younger age groups.
"There is something to be gained by going ahead with research on children. There is a common good to be gained in being prepared” Gutmann says. "[But] We have a long-standing ethical requirement in this country that children not be used merely as means for the public good.”
Many bioethicists have praised the caution of the PCSBI. Lawrence Gostin of Georgetown University said that the anthrax threat was remote, and that the usual testing precautions should be taken: “we really do need to have very rigorous ethical safeguards”.
But others have criticised the recommendations of the commission. Daniel Fagbuyi of the Children's National Medical Center believes that the tests need to take place as soon as possible. "During a time of an emergency when there's enough chaos going on and discord, is that the time we really want to be explaining that, 'Well, we don't have all the evidence at this time…?”
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