The Canadian government said Wednesday that it would donate about 1,000 doses of an experimental Ebola vaccine to the World Health Organization, a day after the group endorsed the idea of using untested treatments in the outbreak in West Africa.
Meanwhile, the experimental treatment ZMapp arrived in Liberia Wednesday to treat two doctors who are infected with the virus. Its manufacturer has said ZMapp supplies are now exhausted, but doctors treating a leading Sierra Leone physician who died from Ebola said Wednesday they considered giving him the drug before it was used in two American aid workers, but feared it could trigger a dangerous immune response and did not administer it.
But with experimental vaccines on their way and treatments fast-tracked, there remain questions about who should receive treatment and how.
It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?
The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.
That means those who ought gain access first are those at greatest risk of exposure to Ebola—health care workers, families of those caring for a sick person, those involved with handling the dead.
What WHO should do is quickly convene an emergency ethics review committee. This group should vet the final distribution proposal, ensure that consent will be obtained, that participants know they can refuse with no penalty and that appropriate follow-up can occur to see what happens after vaccination. They should require information be made available about what will happen if the experimental vaccine causes adverse events or deaths in terms of access to health care and liability.
Sound informed consent is needed with appropriate ‘quiz’ type questions to ensure comprehension by volunteer subjects. No one should feel coerced into trying the vaccine, nor take it believing it is anything other than a long-shot experiment. The recipients should also be told whom to contact if they have an adverse event and for follow up data collection.
The best way to proceed in rationing scarce experimental vaccines in a health care emergency is to distribute them but learn from the experience. That will skew the distribution toward those at highest risk, so the impact of the vaccine can be seen and those best able to consent to the experiment.
Canada’s decision is humane and ethical. The WHO now must ensure that the gift is used wisely to learn whether making and distributing more vaccine now and in the future makes scientific and ethical sense.
First published August 13 2014, 11:25 AM