The Health Practice Commission (HPC) assures the public that its approval of local trials of a new vaccine against COVID-19 followed a strict screening process.
Approval, granted to a local company to begin the first phase of human trials earlier this month, was notable in that it is the first trial approved by HPC to focus on the local volunteers. Past approvals have been for trials have been related to medical tourism.
Over the last few years the Commission has granted about one a year, following extensive vetting and review by HPC members and international experts retained to verify each step of the process.
Healthcare facilities whose applications are approved must undertake to monitor their work and report regularly to the Commission every six months.
In addition to a comprehensive assessment of the science involved in the proposed COVID-19 trials, the Commission also weighed a number of key factors. Among these were: past successful trials by the same company, the involvement of highly respected local physician, Dr Sook Yin, as the primary investigator, and the fact that the approach that the company is taking to the trial means that there is no risk of onward transmission of the viral disease.
“The Commission has done everything that it can to ensure safety and efficacy as it relates to this trial. We also have the legal power to change or halt the trial should a need become evident,” comments HPC Chair, Dr Joseph Marzouca.
Stressing that participation in the trial is solely voluntary, Dr Marzouca, who has himself volunteered to take part, says he was motivated in part to do so by the history of successful clinical trials in the Cayman Islands which have helped to put the country in the vanguard of medical trials and medical tourism globally.
The Health Practice Commission is an eight-member independent body of medical practitioners which includes representatives from the local professional health care associations, from local healthcare facilities and the Department of Planning.
The Department of Health Regulatory Services, which is responsible for registering healthcare entities, serves as a secretariat for the HPC. Only healthcare providers registered in the Cayman Islands may apply to operate medical trials on Island.