‘It is unsafe to undertake Ebola vaccine trial’
The Ghana Academy of Arts and Sciences (GAAS) has stated that the country’s current state of preparedness makes it unsafe to conduct the proposed Ebola Virus Disease (EVD) vaccine clinical trials.
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It has, therefore, stressed that subject to satisfactory answers to the issues it had raised, as well as the gaps in knowledge and the country’s state of preparedness, “it would be unsafe to undertake the proposed EVD vaccine clinical trials in Ghana.”
Warning of the likely side effects on those who may be tested with the Ebola vaccine, the GAAS said the Phase I trial of the GSK vaccine in Europe caused prolonged bleeding in 10 to 15 per cent of the vaccinated population.
“This is a serious adverse effect that calls for extreme caution in approving clinical trials, both Phase I and Phase II, in the country,” the Academy noted, adding that those vaccinated in both phases may also shed the adenovirus vector into the surrounding community.
“In the absence of a map of adenovirus prevalence in the trial sites, there is a high risk of an ‘escape virus’ merging with the endemic adenoviruses to create more virulent strains. For that reason alone it is important the exposed communities and, indeed, the general public be adequately informed of such trials and their benefits and risks,” the GAAS stated.
Shock
The GAAS expressed its shock at the knowledge that a separate Ebola vaccine trial which it was not privy to was planned for Hohoe in the Volta Region.
According to the Academy, it was only at a meeting between the President and Technical Committee of GAAS, and staff of the Ministry of Health, the Food and Drugs Authority (FDA) and its expert advisors, and the principal investigators in the GSK/NIH Phase II trial that it officially learnt of the Hohoe trial.
At the meeting convened by the Minister of Health, Mr Alex Segbefia, on June 3, the Technical Committee of the Academy raised nine key concerns on the Ebola virus, including the vaccine’s composition, the inclusion of children in the trials, the protection available for communities where the trials would be conducted and the evidence of strict compliance of international standards.
“In the course of the meeting it was mentioned that approval had already been given to an application for a separate Phase I trial in Hohoe, of a test vaccine with a different construct from the GSK test vaccine.
“This came as a shock to the Academy representatives at the meeting, as nothing had been said anywhere previously about a separate Phase I clinical trial application, let alone its approval,” GAAS said in a statement issued on the botched clinical trials.