By Martin Cole
The World Health Organisation (WHO) is holding discussions to examine the practicality of trials in which healthy young volunteers are deliberately infected with coronavirus to hasten vaccine development . The plan is controversial and has attracted some criticism, but advocates of the plan claim that the risks of Covid-19 to the young and healthy are minimal, and the benefits to society are high.
The WHO advisory group meeting will focus on reviewing existing plans for “human challenge trials” and discuss associated technical concerns.
Numerous scientific experts are expected to meet as part of the advisory group on Monday, and observers could include representatives of the Wellcome Trust, the Bill & Melinda Gates Foundation, the US-based National Institutes of Health and the FDA.
Phase 1 human trials of ERUCOV-VAC developed at Erciyes University in central Turkey will have already began, and are scheduled to continue for another week, with phase 2 may begin two days later.
Human trials are also taking off in both Vietnam and India, with many more countries to follow in due course. Vietnam’s health minister announced that an indigenous pharmaceutical company and the Military Medical Academy are to run Covid-19 vaccine trials on human participants, the first of their kind in Vietnam. Health Minister Professor Nguyen Thanh Long , confirmed on Saturday that vaccine developers had been asked to speed up progress on their Covid-19 vaccine and commence clinical trials.
The Vietnam ministry announced that 20 participants, aged between 18-40, would receive the vaccine in the first phase of the trial. Phase two trials will involve 40 volunteers.
Meanwhile, human trials are set to begin this month and will be conducted on 250 patients across 20-25 centres in India. Indian pharma company Zydus Cadila has received the Drugs Controller General of India (DCGI) approval to initiate the Phase III clinical trial of its biological therapy,
Public Engagement
WHO have already recommended human challenge programmes should be informed by public engagement, including challenge study participants, or those who have expressed interest in participating, in addition to experts and policymakers.
Human challenge are preferred to conventional vaccine field trials which require researchers to wait for participants to get infected in order to compare outcomes. develop treatments, and gather data about the immediate aftermath of infection, which would be difficult otherwise.
The UK government has invested an estimated £30m to support research involving a human challenge as soon as overall approval is granted. and similar studies are being planned in the Netherlands.
“Pfizer, Moderna, and AstraZeneca together can only produce enough vaccines in 2021 to immunise a third of humanity, and rich countries have already preordered most of their vaccines. Human challenge trials for next-generation vaccine candidates can help ensure there are enough vaccines for the whole world,” 1Day Sooner said.
Meanwhile, Vietnam’s health minister has announced that an indigenous pharmaceutical company and the Military Medical Academy are to run Covid-19 vaccine trials on human participants, the first of their kind in Vietnam. Health Minister Professor Nguyen Thanh Long , confirmed on Saturday that vaccine developers had been asked to speed up progress on their Covid-19 vaccine and commence clinical trials.
The Vietnam ministry announced that 20 participants, aged between 18-40, would receive the vaccine in the first phase of the trial. Phase two trials will involve 40 volunteers.
Meanwhile, human trials are set to begin this month and will be conducted on 250 patients across 20-25 centres in India. Indian pharma company Zydus Cadila has received the Drugs Controller General of India (DCGI) approval to initiate the Phase III clinical trial of its biological therapy,