Human challenge studies of potential COVID-19 vaccines, in which volunteers are deliberately infected with the disease, could become a reality after a UK biotech company announced in advanced talks with the government that it would create and supply strains of the virus .
The preparatory work for the studies, which aim to accelerate the process of determining the effectiveness of a vaccine candidate, is being carried out by hVIVO, a unit of the pharmaceutical services group Open Orphan.
“We are currently in discussions with numerous parties, including the UK government, on a COVID-19 challenge study. As soon as one of these contracts is signed, we will make an announcement,” said Cathal Friel, Executive Chairman of Open Orphan.
If so agreed, this would include creating a model for a human challenge study that could be used if such studies were given ethical and safety approval by regulatory agencies.
The UK Government’s Business, Energy and Industrial Strategy Department (BEIS) was not immediately available for comment.
Proponents of human challenge studies say they are a great way to end the often tedious process of testing potential vaccines on tens of thousands of real world volunteers who lead normal lives and are monitored to see if they are comfortable with the Infect disease or are protected, shorten it.
In these tightly controlled studies, volunteers are given a vaccine and then deliberately infected with the disease under controlled conditions about a month later. They are then isolated and monitored in a quarantine facility to see if they get sick or if the vaccine is protecting them.
Critics say it is unethical to intentionally infect someone with a potentially fatal disease for which there is currently no effective treatment.
Any human challenge trials conducted in the UK would need to be approved by the Medicines and Health Products regulator, the health oversight agency that deals with safety, ethics and protocol.
(This story was not edited by GossipMantri staff and is automatically generated from a syndicated feed.)