In a March 19 report issued by the Presidential Commission for the Study of Bioethical Issues, an ethics panel tentatively gave the go-ahead for researchers to test an anthrax vaccination on children.
Setting off a swirl of controversy, the ethical review comes in response to a request from U.S Health and Human Services Secretary Kathleen Sebelius after a 2011 bioterrorism preparedness exercise in San Francisco revealed that 8 million people would be affected by an anthrax attack, nearly a quarter of them children.
The problem, noted agency officials, was that should such an event occur, there were no protocols in place for treating children exposed to the bacteria. The current federal plan – immediate distribution of antibiotics -- would not provide long-term protection because anthrax spores can pose a threat of infection long after their initial release.
According to the Commission’s news release, at issue is determining an acceptable dose of the vaccine for children. Vaccine administration is also challenging because there is no understanding of its effect on children despite its commercial production for more than four decades and its use on more than a million adults in the military.
Caveats to testing
Along with the perceived need for an anthrax vaccine for children, comes the panel’s acknowledgement that a considerable number of hurdles have to be overcome before the launch of an anthrax vaccine trial in children.
“The safety of our children is paramount and we have to get this precisely right,” said Commission Chair Amy Gutmann, PhD, in a Commission news release.
“The bioethics committee concludes that many significant steps would have to be taken, including additional minimal-risk research with adult volunteers, before pediatric anthrax trials prior to an attack should be considered,” added Gutmann.
The Commission is very clear that research with children is ethically distinct from other research, especially when the research in question promises no prospect of direct benefit for the participants. Children are legally prohibited and ethically unable to consent to accept this burden.
Research that takes place before a bioterrorism attack happens is also ethically different from research that would take place after an attack. Pre-event testing involves a hypothetical condition and participants in such a study would face more than minimal risk because the side-effects to children are unknown.
Because of the unknown risks, the report stipulates that any clinical trials of treatments such as the anthrax vaccine need to first show a lack of serious side-effects in animals and adults. The panel also recommended an “age de-escalation” approach where tests first be conducted on the youngest adults, starting at 18 years of age. If the vaccine is determined to be safe for 18-year-olds, then trials go on to 17-year-olds and continue to move on to younger children.
The youngest age for testing, however, is not clear and there is concern that what might be safe for a 16-year-old or a 4-year-old could be unsafe for infants.
A controversial decision
Critics of the Commission’s recommendations have been quick to respond, saying that the Commission should have unequivocally opposed testing the anthrax vaccine on children. Activists also point to data from a 2008 study that reported a number of serious side effects in adults who had received the vaccination.
A leading opponent of the vaccine, Vera Sharav, founder of the Alliance for Human Research Protection, told Reuters News that such a study would cause “moral harm for us as a nation and suffering for children. They should have said ‘thou shalt not.’”
Steven Krug, MD, chairman of the American Academy of Pediatrics’ disaster preparedness advisory council, acknowledges both sides of the question in USA TODAY.
“It’s a rock-and-a-hard place decision. We need to test these treatments to know if they will work, but there are serious questions to consider before doing that sort of testing on children."
It is now up to Secretary of Health and Human Services Sebelius to decide whether to proceed with clinical trials on children.