“Human challenge” trials of potential COVID-19 vaccines, where volunteers are deliberately infected with the disease, could become a reality after a British biotech company signs a government contract to create and supply strains of the virus .
HVIVO, a unit of pharmaceutical services company Open Orphan, is conducting preliminary work for the trials, which aim to speed up the process of determining the efficacy of a candidate vaccine, hVIVO said Friday.
This involves creating a human challenge study model that could be used if such assays obtain safety and ethical approval from regulators.
“The development of the model involves the manufacture of the challenge virus and the first human characterization study for this virus,” the company said.
Supporters of human provocation trials say they are a good way to shorten the often lengthy process of testing potential vaccines on tens of thousands of real-world volunteers who lead normal lives and are monitored for the disease. disease or are protected. of that.
In these strictly controlled trials, volunteers are given a vaccine and then, about a month later, are deliberately infected with the disease under controlled conditions. They are then isolated in a quarantine facility and monitored to see if they get sick or if the vaccine protects them.
Critics say that deliberately infecting someone with a life-threatening disease for which there is currently no effective treatment is unethical.
Any human provocation test conducted in Britain would have to be approved by the Medicines and Healthcare Products Regulatory Agency, the health regulator that looks at safety, ethics and protocol. Any evaluation will take place after hVIVO completes its groundwork.
The characterization study, the first step in finding the correct form and dose of the virus that could be used to deliberately infect participants in future trials, is supported by Imperial College London and will be conducted by hVIVO in a specialized research unit in Royal Free of London. Hospital.
The work will be carried out “under the scrutiny of highly trained scientists and physicians,” hVIVO said in a statement.
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