Who must answer to GAAS

(THE WORLD HEALTH ORGANISATION MUST RESPOND TO THE QUERIES OF THE GHANA ACADEMY OF ARTS AND SCIENCES)

By Akyaaba Addai-Sebo

The World Health Organisation (WHO) and its agents in Ghana should not seek to pull the wool over the eyes of Ghanaians over public outcry against the Ebola Vaccine trial which has forced the trial lead scientist, Prof. Fred Binka, to offer to “personally undergo the clinical trial as proof of its safety”, in an interview with Starr News. Following Prof. Binka’s heels is the Ministry of Health embarking on “an education program to allay public fears.”

Ghanaians, through the Ghana Academy of Arts and Sciences (GAAS), have posed Ten Queries which WHO is required to take extremely seriously and reply to. The “political” theatrics of Prof. Binka must not be allowed to divert attention from the ten queries posed by GAAS which he and WHO are bound to provide answers to.

The eminent Ghanaian medical doctor, Prof. Felix Konotey-Ahulu, has given his full marks to the GAAS queries made to WHO and has added his professional voice to those demanding that WHO must foremost answer directly to GAAS and indirectly to parliament which, in the national and public health interests, have halted the clinical trial.

It is in the public interest that the Ghanaian media and campaigning organisations put their weights behind the Ghana Academy of Arts and Sciences and harp on the urgency of WHO responding to the Ten Queries. The pressure must be brought unceasingly on WHO and their local agents to respond to the fundamental questions raised by GAAS in the national interest.

Prof. Konotey-Ahulu has used the pages of the British Medical Journal (http://www.bmj.com/content/350/bmj.h2105/rr-7 ) to “invite the most brilliant scientists in Johns Hopkins, Harvard, Oxford, Utrecht, NIH, CDC, and London School of Tropical Medicine & Hygiene to study this GAAS Communique from which they will derive much benefit as they go about their own vaccination programmes in Europe, USA, and elsewhere.”

Below are the 10 Queries that must be answered first and above all else by the World Health Organisation and their local agents. The public experts the Ministry of Health to be demanding the same from WHO as the ministry is their first point of call in seeking to introduce the Ebola Vaccine trial:

“1. Major uncertainties about a. the nature and origins of the Ebola virus, including the circumstances of its appearance in Guinea;

2. 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;

3. 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;

4. 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?

5. 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?

6. 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?

7. 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;

8. 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?

9. 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;

10. What evidence is there of strict compliance with the International Committee on Harmonization Protocol Guidelines for Clinical Trials, including full “informed consent” by all volunteers?

The Minister of Health has a duty to parliament and the general public to see to it that the above 10 queries are responded to by WHO and it is this response that may guide the ministry in its public education exercise.

The World Health Organisation must answer to the queries of the Ghana Academy of Arts and Sciences above all else.

Akyaaba Addai-Sebo

Independent Consultant on National Interest

addai@tribute3ml.com

19 Church Road, Barnes, London, SW13 9LS

Below is the Academy’s full narration of events leading up to the announcement of the Ebola vaccine trial in Ghana:

In January this year, the Ghana Academy of Arts and Sciences became aware, from a newspaper report, that a clinical trial for an Ebola Virus Disease (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;

2. 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;

3. 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;

4. 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?

5. 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?

6. 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?

7. 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;

8. 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?

9. 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;

10. What evidence is there of strict compliance with 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

Honorary Secretary, Ghana Academy of Arts and Sciences

12 June 2015