Friday, 19 June 2015

Press statement on Ebola Vaccine Trials

PRESS STATEMENT BY GHANA ACADEMY OF ARTS AND SCIENCES ON PROPOSED PHASE II CLINICAL TRIAL OF A GHANA ACADEMY VACCINE FOR EBOLA VIRUS DISEASE IN GHANA OF ARTS AND SCIENCES n January this year, the Ghana Academy of Arts and Sciences became aware, from a newspaper report, that a clinical trial for an Ebola Virus IDisease (EVD) vaccine was due to start in Ghana before the end of March. Given the uncertainties about the nature of the Ebola virus and risks in clinical trials, the Academy set up a 5-person Technical Committee made up of Fellows of the Academy to undertake an urgent review of the matter and report to the Academy. In its preliminary report, the Committee noted, among other things, that the proposal before the Food and Drugs Authority (FDA) was for a Phase II clinical trial of an Ebola Virus Disease (EVD) vaccine, developed by GlaxoSmithKline/US National Institutes of Health (NIH). Such an undertaking must be preceded by a thorough evaluation of the available data, and the application subjected to the appropriate procedures. On the basis of its preliminary investigation and study, the Committee recommended a second look at the design of the study; a review of the basis for the selection of Ebola-unaffected countries like Ghana; and, because some Ghanaians have anti-bodies to the adenovirus, a fuller understanding of the adenovirus vector used in the development of the test vaccine. In discharge of the Academy's mandate to provide independent science- based advice for policy making, the Council of the Academy asked the President of the Academy to bring these concerns urgently to the attention of the Minister of Health. This was immediately done, attaching a copy of the preliminary report of the Committee and confirming the Academy's preparedness to provide all necessary support to the Ministry in dealing with this critical matter. After some delay, the newly-appointed Minister of Health convened a meeting on June 03, at which the concerns and issues raised by the Academy were discussed with the technical staff of the Ministry of Health (MOH), the Food and Drugs Authority and its expert advisors, as well as the Principal Investigators in the GSK/NIH Phase II trials. The main concerns raised by the Technical Committee of the Academy relate to the following: 1. Major uncertainties about a. the nature and origins of the Ebola virus, including the circumstances of its appearance in Guinea, b. whether the Zaire strain of the virus, which is the one being used in the GSK vaccine to be tested in Ghana, is the strain responsible for the Ebola epidemics in Liberia, Mali, Nigeria, Senegal and Sierra Leone, and c. the identity and characteristics of other strains of the Ebola virus that might exist; 2. The use in the GSK/NIH vaccine of a gene particle of the wild species of the Zaire Ebola virus, rather than the gene particle of the Makona strain isolated in the epidemic in Guinea; 3. What pre-clinical animal experimentations had been carried out with a vaccine based on the Makona strain to establish evidence of safety, immunogenicity and protection; 4. What basis is there for expecting that immune responses generated against the wild type Zaire Ebola virus GSK vaccine formulation (construct), with a live non-replicating chimpanzee adenovirus carrying a gene from Zaire Ebola virus, would be effective against the Makona strain or any other Ebola virus species and strains; 5. After a test vaccine has been shown in the vaccinated individual to produce an immune response (immunogenicity), what guarantee would there be, in this instance, that the vaccine would offer protection against the full Zaire Ebola virus and other species and strains; 6. On the basis of research conducted so far towards vaccine development, what is the likelihood of the present construct of vaccines protecting communities against the rapid emergence of new, more virulent strains of the virus, as appears to have happened with the Makona: the risk of false confidence deriving from the use of a new vaccine must be noted; 7. What assurances do we have that the chimpanzee-derived live adenovirus vector used in the GSK vaccine construct, although non- replicating for now, will remain dormant and not itself cause a disease to compromise the health of the people of Ghana; 8. It is to be noted that the application for the GSK Ebola vaccine Phase II trial in Ghana includes children, even though the Phase I trial in the US, UK, Mali and Switzerland was limited to adults, raising the question of dosage profiles for children and other vulnerable groups in the Phase II trial; 9. What evidence is there of strict compliance with the The International Committee on Harmonization Protocol Guidelines for Clinical Trials, including full “informed consent” by all volunteers. It was confirmed at the above-mentioned meeting between the President and Technical Committee of the Ghana Academy of Arts and Sciences, and staff of the MOH, the Food and Drugs Authority (FDA) and its expert advisors, and the Principal Investigators in the GSK/NIH Phase II trial, that the processes for the approval of the Phase II clinical trial of the GSK Ebola Virus Disease test vaccine had not been concluded. Our firm understanding was that the approval process will continue to take into account the concerns and issues raised by the Academy. In the course of the meeting, it was mentioned 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, which latter had been the focus of concern of the Academy. 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. The Academy's representatives therefore refused to discuss that matter. However, it is to be noted that the Phase I trial of the GSK vaccine in Europe produced an adverse event, namely, prolonged bleeding, in 10% - 15% of the vaccinated population. This is a serious adverse event that calls for extreme caution in approving clinical trials, both Phase I and Phase II, in the country. Moreover, it is the case that those vaccinated at Phase I and Phase II may be shedding 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 that the exposed communities and, indeed, the general public be adequately informed of such trials and their benefits and risks. In conclusion, the Ghana Academy of Arts and Sciences wishes to state its firm position that, subject to satisfactory answers to the issues it has raised, and considering the gaps in our knowledge and state of preparedness, it would be unsafe to undertake the proposed EVD vaccine clinical trials in Ghana. The Academy affirms its availability to help the Ministry of Health, the Food and Drugs Authority (FDA) and other parties involved in the approval process to arrive at sound, independent decisions on this and other critical matters facing the country. [The Ghana Academy of Arts and Sciences, with a membership of 111 Fellows drawn from all fields of learning, has from its inception in 1959 been charged with a key role in thought leadership and making inputs into policymaking through research and evidence-based advice. Over the years efforts have been made, and continue to be made, to re-profile the Academy in the light of changing conditions] Issued by the Honorary Secretary, Ghana Academy of Arts and Sciences, #1 CSIR Close, Liberation Link, Airport Residential Area 12 June 2015

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