Ebola Vaccine Trials Not Harmful – Experts
A team of experts from various health institutions in the country have assured Ghanaians of the safety of the Ebola vaccine trials.
According to the experts from the Noguchi Memorial Institute of Medical Research, University of Health and Allied Sciences (UHAS), Ghana Standards Authority (GDA) and the Ghana Health Service (GHS), the vaccine has satisfied both local and international requirements and would not have adverse effect on the health and lives of people who are exposed to it.
This assurance was given when the experts took turns to engage the public in a forum recently held in Ho, the Volta regional capital.
The forum was to explain the nature and processes of the proposed clinical trials of the Ebola vaccine to allay the fears and misconceptions of the public that the exercise could lead to the spread of the disease in Ghana.
Professor Fred Binka, Vice Chancellor of UHAS and the lead investigator on the project in Hohoe, said, “Everyone’s safety is the research team’s priority, hence there should be no cause for alarm.”
He explained that before such trials are done on humans, the vaccines are tested in laboratories, then animals; thus from rodents through to primates to ensure safety and efficacy of the vaccine.
Ghana is planning to do a Phase I trial of Johnson and Johnsons and Phase II of GSK in Hohoe in the Volta Region while Kintampo in Brong-Ahafo is doing just the Phase II of GSK trial.
According to him, the two places were chosen because they both have well-equipped clinical trial facilities of international standard and international known for clinical researches.
Response to GAAS
Prof Kwadwo Koram, Director of Noguchi Memorial Institute and a member of the team, pointed out that the objective of the proposed clinical trials in Ghana is to contribute towards the development of an effective vaccine to protect populations in future outbreaks of the disease in the West African sub-region.
Prof Koram said every little detail and safety measures have been employed according to the International Committee on Harmonisation (ICH) Protocol Guidelines right from scientific and ethical review, assessment of the trial facilities, assessment of human capacity, constant monitoring of the process, among others.
FDA approval and Compensation
Acting Deputy Chief Executive Officer (CEO) in-charge of Safety Monitory and Clinical Trial at the FDA, Mrs Delese Mimi Darko, assured Ghanaians that the vaccine had also undergone review in accordance with manufacturing practices before being approved by the ethics committee.
She said that the FDA which is recognised as a regulatory centre of excellence in Africa in the area of clinical trials would monitor the entire process.
Dr Ama Edwin of GHS Ethics Review Committee also mentioned that the trial is strictly voluntary and volunteers who begin the trial and decide not to partake will not be prevented.
More so, the volunteers will be taken through an entire process of education before being enrolled. They will also be given an approved compensation of only GH¢200 on every visit.
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