Select 100 healthy volunteers, immunize them, and then inoculate them with the virus: the controversial proposal to speed up the vaccine
Vaccination is slow. For weeks, we've echoed the famous estimate that, at best, vaccines would take no less than 12 or 18 months to arrive. There are good reasons for this: a vaccine, and this one in particular is no exception, is administered by millions. Any failure, any security problem, could cause a health catastrophe.
However, when the safety of the vaccine is demonstrated, there will be one more step left: demonstrating that it works. This is usually done with large Phase III studies in which the vaccine is administered to large numbers of people and a placebo to others. The problem is that these studies require that time pass and that these people are naturally exposed to the virus.
And it is precisely that, time, what we do not have.
A shortcut (which can cost lives)
For this reason, there is a small (but increasingly numerous) group of researchers who are putting a radical idea on the table: select 100 healthy volunteers, vaccinate them, and then inoculate them with the virus. With such a study we could have very fast information. But, on the way, we would risk a good handful of lives. That is the debate.
Nir Eyal, director of the Center for Population-Level Bioethics at Rutgers University, is one of the most visible voices among this group of researchers. Their arguments are simple. The first, in line with what we were saying, is that, in a scenario like the current one (where the whole world is in 'social distancing') waiting for the subjects of the Phase III study to become infected condemns us to waiting too long.
By cons, it is not the first time that we do this type of study. Disregarding the wildest cases in our history, we can find clinical trials of this type for diseases such as influenza, typhoid, cholera or malaria in recent years. In fact, these recent trials teach us that there are ways to reduce risk.
We can now confirm the safety of the vaccine much better than before. We can also select a group of people with low risk (healthy young people without previous pathologies) and monitor them very closely to identify any sign of the disease in real time. After all, as far as we know so far, early treatment is a key factor in the good prognosis of the disease.
Risk and morality
Still, the risk remains, and current practices within the world of bioethical research tend to rule out this type of evidence. Above all, in cases like this, in which the treatment is not only unclear but changes radically almost every week and the risk of ending the lives of some of the volunteers cannot be ruled out.
In fact, although Eyal points out that trials of this type are usually carried out in less dangerous diseases, we also have the opposite case: a few years ago the US considered doing a study of this type to test the Zika vaccine, but it was ruled out. In other words, the debate is there and, as the epidemic continues to grow, the calls to step on the accelerator become stronger.
Image | Dimitri Houtteman