‘Human challenge’ trials of potential COVID-19 vaccines, where volunteers are deliberately infected with the disease, could become a reality after UK biotech firm says it is in advanced talks with government to create and deliver strains of the virus.
Preliminary work in the trials, which aims to speed up the process of determining the efficacy of a candidate vaccine, is being led by hVIVO, a unit of the Open Orphan pharmaceutical services group, the company said.
“We are in talks with many parties, including the UK government, around a COVID-19 challenge study, and once one of these contracts is signed, we will make an announcement,” said the executive chairman of ‘Open Orphan, Cathal Friel.
If agreed, it would involve creating a human provocation study model that could be used if such trials gained ethical and safety approval from regulators.
The UK government’s Business, Energy and Industrial Strategy (BEIS) department was not immediately available for comment.
Proponents of human challenge trials say they’re 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 being watched for. if they contract the disease or are protected. From this.
In these tightly 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 is protecting them.
Critics say deliberately infecting someone with a life-threatening illness for which there is currently no effective treatment is unethical.
Any human provocation trial conducted in Britain would have to be approved by the Medicines and Health Products Regulatory Agency, the healthcare regulatory body that reviews safety, ethics and protocol.
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