Tag: trials

Challenge trials for a coronavirus vaccine are unethical – except for in one unlikely scenario
COVID-19

Challenge trials for a coronavirus vaccine are unethical – except for in one unlikely scenario

The world urgently needs a vaccine for COVID-19. Only when a vaccine is approved and people are safe can countries fully end their lockdowns and resume normal life. The trouble is that such vaccines usually take years to develop and test for efficacy and safety. Recently, some bioethicists have proposed a way of speeding up this testing process by several months. Researchers would put volunteers in quarantine with access to the best medical care, give these volunteers one of the trial vaccines and then directly expose them to the coronavirus. This type of intentional exposure is called a challenge trial, and since researchers would not have to wait for subjects to encounter the virus in the normal course of their daily lives, it could result in a vaccine much faster than a normal trial. R...
The ethical case for allowing medical trials that deliberately infect humans with COVID-19
COVID-19

The ethical case for allowing medical trials that deliberately infect humans with COVID-19

Despite the urgent need to beat COVID-19, health officials may be delaying the development of an effective vaccine. Authorities in the U.S. and elsewhere are yet to authorize an ethically charged research procedure called “human challenge trials.” Challenge trials entail deliberately infecting volunteers with the disease – which explains the official reticence – but they could substantially expedite the development of a vaccine. The debate over human challenge trials has been raging for months among health professionals and academics. But only now – some eight months into the pandemic – are authorities in the U.S. beginning to consider them in a bid to speed up the vaccine-development process. Sitting and waiting A vaccine has to go through multiple stages before it can be rolled out. Af...