pharmatimesOctober 22, 2020
Tag: COVID-19 , Vaccine , UK , NHS
The UK government has joined forces with experts from the NHS, academia and the private sector to explore and establish human challenge trials to aid the development of a COVID-19 vaccine.
Human challenge studies test a vaccine candidate that has be proven to be safe in initial trials in a small number of healthy adult volunteers, who are then exposed to the virus in a controlled environment.
The volunteers are then closely monitored by medics and scientists for 24 hours per day to determine exactly how the vaccine works and to identify any side effects.
The research team will initially aim to discover the smallest amount of the novel coronavirus it takes to cause COVID-19 infection in small groups of healthy young people aged between 18-30 who are at a lower risk of harm.
Previously, human challenge studies have played a key role in accelerating the development of therapeutics for diseases including malaria, typhoid, cholera, norovirus and flu.
These trials have also aided researchers in establishing which possible vaccine is most likely to succeed in phase 3 studies that usually involve thousands of volunteers.
The proposed research will first be considered by regulators in the UK, including the Medicines and Healthcare products Regulatory Authority (MHRA) and the NHS Health Research Authority through research ethics committees before launching.
“We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine,” said Business Secretary Alok Sharma
“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life,” he added.
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