Citizens kick against Ebola vaccine trial
AN Ebola vaccine trial to be undertaken in Ghana has been suspended by Ghana’s Minister of Health while the country’s Parliament has also vehemently opposed it.
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The suspension of the trial came after Ghana’s Food and Drugs Authority (FDA) gave approval for the trial to be undertaken in the country amid protest from members of the community where the trial was to be undertaken.
The 18-month-long trial of the GlaxoSmithKline and National Institutes of Health (GSK/NIH) vaccine developed from a gene particle to the species of the Zaire Ebola virus is being sponsored by GSK, a British multinational pharmaceutical company headquartered in Brentford, London.
The vaccine trial which was to be undertaken in Hohoe, a local community in the Volta Region of Ghana, was expected to help find a vaccine for the Ebola viral disease (EVD) which infected more than 8,000 people, especially, in Liberia, Sierra Leone and Guinea, killing more than 4,000 people.
Twelve 12 participants are expected to be recruited for the trial. The participants are expected to be fit and healthy and between the ages 18 to 50.
Pregnant women, lactating mothers, the elderly and children would not be involved.
The participants who would sign an informed consent form must also be literate in English, Twi (which is one of Ghana’s predominantly spoken local languages) or Ewe, which is the dialect of the participating community.
Participants will be compensated for their time with GHc200 ($50) per scheduled visit to the trial site and a mobile phone so that they will be monitored frequently by the trial investigators.
The Kintampo Health Research Centre (KHRC) at Kintampo in the Brong Ahafo Region, and the Onchocerciasis Chemotherapy Research Centre (OCRC) at Hohoe, have been proposed by the sponsors as prospective trial centres.
Community protest
Residents of the participating community, upon hearing of the vaccine trial, opposed it, saying the scientists were introducing Ebola into the country.
According to them, Ghana had been fortunate not to have been hit by the dreaded virus and, therefore, Ghanaian scientists had no business bringing the disease in the form a vaccine into the country.
A resident of Hohoe, in an interview, said, the Ebola virus was able to devastate Liberia, Guinea and Sierra Leone because of weak health systems.
According to the resident, who wants to remain anonymous, Ghana also had a weak health system as the country did not have any infectious disease centre where such cases would be referred to should there be an outbreak.
“Look at what cholera did to our health systems last year. The disease killed hundreds of people as our health system became helpless.
“My sister can you imagine the havoc Ebola will cause should it surface here.
“Let the scientists take their Ebola to other countries and not bring it to Ghana”, the resident added.
Parliamentary protest
The Member of Parliament (MP) for Ho West, Emmanuel Kwesi Bedzra, who made a statement in the name of the Volta Caucus in Parliament, demanded an immediate suspension of the planned human trials of the vaccine in Ghana.
“We wish to call for an immediate suspension of this trial. As representatives of the people, we owe it a duty to our constituents to ensure their safety and well-being and we will stop at nothing to stop that,” the MP said.
He said “We are not against our research institutions undertaking research and medical trials but we cannot accept the situation where the proposed trial is carried out without proper communication and interaction with major stakeholders in the region.”
Deliberating the MPs statement on the floor of Parliament other MPs also aggressively protested against the trial, saying it was going to lead to an outbreak of Ebola in the country.
The parliamentarians, after deliberations, summoned the Minister of Health, Mr Alex Segbefia to appear before them to brief them on the proposed Ebola vaccine trial.
Minister’s response
In his response to the concerns of the MP, Mr Segbefia among other things said the outbreak of the Ebola virus disease last year caught Africa and indeed the whole world unawares and totally unprepared. It traumatised and decimated many communities in other West African countries namely Guinea, Liberia and Sierra Leone.
He said at the height of the epidemic last year, African leaders and, especially, leaders of the ECOWAS sub-region made urgent appeals to the international community and the WHO, in particular, to assist not just in relief operations, but more importantly, in finding a cure or vaccine for the dreaded EVD.
He said in response to urgent appeals from leaders in the sub-region and the cries of all people, the WHO rallied around pharmaceutical, research and development companies that had prospective candidate medicines and vaccines, some of which were being administered as trials on medical personnel who had contracted the disease while working as volunteers in some disease stricken areas in West Africa.
The WHO facilitated a meeting of the African Vaccine Regulatory Forum (AVAREF) in South Africa to consider how to accelerate the process of approving prospective candidate medicines or vaccines.
Given the urgency of the situation, participating countries agreed to undertake joint reviews of clinical trials applications in order to reduce the time usually taken to process applications. The final decision as to whether to approve clinical trials or not, however rested with the regulatory agencies in individual countries.
Mr Segbefia said subsequent to the meeting in South Africa, the WHO wrote to regulatory bodies of Ghana and four (4) other West African countries namely Nigeria, Senegal, Cameroun and Mali, notifying them of the intention of Glaxo Smith Kline (GSK), one of the world’s leading pharmaceutical companies, to submit a candidate vaccine for clinical trials in the respective countries.
The WHO subsequently convened a joint review meeting in Geneva on December 14 to 15, last year which was attended by a number of international health regulatory bodies including Health Canada, Swissmedic, European Medicines Agency (EMA) and the USA Food and Drugs Administration.
Following the Geneva meeting, he said GSK submitted an official application on December 17, 2014 to the Ghana Food and Drugs Authority for authorisation to conduct clinical trials.
WHO assures
Following the protest from all quarters concerning the Ebola vaccine trial, the WHO, at a public sensitisation durbar organised at the instance of the Minister of Health, Mr Alex Segbefia, assured Ghanaians that the proposed Ebola vaccine trial would not cause Ebola in the country.
The WHO Country Representative, Dr Magda Robalo, said the organisation views the safety of people as paramount and would, therefore, not overlook any wrongdoing in the development of a vaccine.
“We have a generational opportunity to stop an outbreak which has been around for over 40 years and there shall be no wrongdoing under our watch,” she stated.
She said currently there were 10 vaccines on trial, and WHO would continue to monitor them to ensure that developers followed laid down procedures.
Dr Robalo commended Ghana for the work so far done on Ebola and described the debate on the vaccine trial in the country as healthy, as people had the right to know what was going on.
Corroboration
The Vice-Chancellor of the University of Health and Allied Sciences based in Ho, in the Volta Region of Ghana, Professor Fred N. Binka, for his part, debunked speculations by a section of the public that Ebola was being introduced into the country.
He said the Ebola vaccine clinical trial to be conducted in the country could not cause Ebola.
He said the time for the vaccine to be tried was now, since in the next 12 months, there might not be any Ebola patient who could be used to test the potency of the vaccine. That, he explained, would be adverse in the event of another outbreak, as the processes for the search of a vaccine would have to be started.
He said the vaccine, therefore, needed to get out of the second phase so that the third phase would use Ebola patients from the affected countries.
Correcting the erroneous impression that the Ebola vaccine was a virus, Prof. Binka said the strain which was to be used could not replicate itself.
Developments on Ebola vaccine trial
A researcher at the KHRC, Dr Kwaku Poku-Asante at the public durbar, in response to some concerns raised also by the Ghana Academy of Arts and Sciences, which had also asked for the vaccine trial to be stopped, said the first phase of the trial had already been conducted in the United States of America, the United Kingdom, Mali and Switzerland.
According to him, the second phase which Ghana was to participate in was to use the GSK/NIH vaccine being developed from a gene particle to the species of the Zaire Ebola virus, rather than the gene particle of the Makona strain isolated in the epidemic in Guinea.
He said the Zaire strain was reported in the scientific journals as the main strain which caused the epidemic in all the countries in the West Africa region.
Dr Poku-Asante said pre-clinical studies in primates had shown safety and immunogenic after challenge studies, adding that high protection was achieved after challenging the animals with a very high dose, more than what is believed to be responsible for infections in the current outbreak.
The next stage, he said, was to evaluate safety, tolerability, immunogenicity and efficacy in humans, adding that “these studies would have to demonstrate a public health benefit else the vaccine would not be licensed”.
A member of Ghana’s scientific community, Professor Alex Dodoo of the School of Medicine and Dentistry of the University of Ghana, Legon, in an interview said Ghana risked missing an international opportunity to partake in the Ebola vaccine trial if things are not resolved.
Should the trial be terminated indefinitely, Prof. Dodoo said “Ghana’s image and ability to develop would be damaged because no pharmaceutical company will come to the country as it appears that our laws are arbitrarily applied,” he regretted.
He said it was sad that the FDA which had been mandated by the country’s laws could be prevented from doing its work.
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A Daily Graphic publication in collaboration with Ouestaf News and with support from Osiwa.