LONDON (UK) – “Human challenge” trials of potential COVID-19 vaccines, in which volunteers are infected with the disease deliberately, could be materialised. This has come after a contract was signed by the British biotech firm with the government to create and provide strains of the virus.
A unit of pharmaceutical services company Open Orphan, hVIVO said on Friday, preliminary work for the trials, trying to determine the efficacy of a vaccine candidate, is being carried out by hVIVO.
A human challenge study model would be created that could be used if the trials get ethical and safety approval from regulators.
The company said, “The model development involves the manufacture of the challenge virus and the first-in-human characterisation study for this virus,”
Supporters of human challenge trials say it is a good way to reduce the lengthy process of trying the potential vaccines on tens of thousands of volunteers who are later monitored if they contract the disease or are protected from it.
When the volunteers are deliberately infected with a vaccine, they are then isolated in a quarantine facility and are under examination if they become sick or if the vaccine protects them.
Critics say such a method is unethical.
Human challenge trials conducted in Britain would have to be approved by the Medicines and Healthcare products Regulatory Agency, the healthcare regulator that predominantly looks into safety, ethics and protocol.
The characterisation study, the first step towards finding the right form and dose of the virus, is supported by Imperial College London and will be conducted by hVIVO at a specialist research unit at London’s Royal Free Hospital.
The work will be carried out “under the scrutiny of highly trained scientists and medics”, hVIVO said in a statement.