A team of experts have assured Ghanaians that the vaccine against the Ebola viral disease to be tested in Ghana is not harmful.

downloadAccording to them the vaccine has satisfied all requirements; both local and international and will not have adverse effect on the health and lives of people who were exposed to it. In addition to that volunteers for the trials will all be comprehensively insured to ensure their health and safety.

This assurance was given when 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) took turns to engage the public in a forum recently in Ho, the Volta Regional Capital.

The forum was held 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 ones safety is the research teams 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. Before Ghana, similar studies have been done in the USA, UK, Switzerland, Germany, Mali and Gabon while Uganda and Kenya are currently undertaking same.

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, these two places were chosen because they have both have well equipped clinical trial facilities of international standard and international known for clinical researches. Hohoe has the Oncho research center while Kintampo has the Kintampo Health research Center.

Response to GAAS

Prof. Kwadwo Koram, Director of Noguchi Memorial Institute and Member of the Team noted 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, especially frontline workers.

Prof. Koram who was reacting to concerns raised by the Ghana Academy of Arts and Sciences (GAAS) emphasized that the vaccine will be used to immunize populations without infection nor disease; thus normal healthy Ghanaian adults (18 to 50 years) to determine the safety and tolerability in the first instance.

To this end, every little detail and safety measures has been employed according to the International Committee on Harmonization (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

The 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 recognized as a Regulatory Centre of Excellence in Africa in the area of clinical trials will monitor the entire process. She said the FDA had recently supported Liberia, Ivory Coast, Kenya, Burkina Faso and Uganda in the review of the clinical applications for anti-Ebola vaccine.

Dr. Ama Edwin of GHS Ethics Review Committee also noted that the trial is strictly voluntary and volunteers who begin the trial and decide not to partake will not be prevented. Mores 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?200.00 on every visit. This she said is not to persuade nor coerce volunteers.

By Kwadwo Duodu

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