Minister Of Health’s Statement to Parliament on proposed anti-Ebola Vaccine Clinic Trials

STATEMENT TO PARLIAMENT ON THE PROPOSED ANTI-EBOLA VACCINE CLINIC TRIALS IN GHANA BY THE MINISTER OF HEALTH, HONOURABLE ALEX SEGBEFIA ON TUESDAY 16TH JUNE, 2015

Background

Rt. Hon. Speaker, I appear before this august House in response to your summons to brief Parliament on Ebola vaccine trials in Ghana.

The summons, Mr. Speaker, followed the statement by the Volta caucus on the floor of the House in which it expressed some reservations on Ebola vaccine trials in the Hohoe District of the Volta Region. While the concerns may have been specifically related to proposed trials in the Hohoe District, there is no gainsaying the fact that the issue has assumed a national dimension and understandably so, given the fear and trepidation that Ebola disease causes in all of us.

Mr. Speaker, The outbreak of the Ebola Virus Disease (EVD) last year caught Africa and indeed the whole world unawares and totally unprepared. It traumatized and decimated many communities in fellow West African countries namely Guinea, Liberia and Sierra Leone.

Mr. Speaker, 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 Word Health Organization (WHO) in particular, to assist not just in relief operations, but more importantly, in finding a cure or vaccine for the dreaded EVD.

His Excellency John Dramani Mahama, our own hardworking President, who was at that time Chairman of ECOWAS, provided inspirational leadership, helping to garner international support to deal with the epidemic. Ghana became the operational base of the international relief operations and President Mahama even took the bold decision to visit Ebola stricken West African countries as an expression of deep concern and manifestation of brotherly love and human solidarity.

Mr. Speaker, in response to urgent appeals from leaders in our sub-region and the cries of all our peoples, 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.

Mr. Speaker, in October 2014, 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. Speaker, 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 our respective countries. The WHO subsequently convened a joint review meeting in Geneva on the 14th and 15th of December 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.

Mr. Speaker, following the Geneva meeting, GSK submitted an official application on December 17th to the Ghana Food and Drugs Authority for authorization to conduct clinical trials. In February 2015, the FDA received another application from Johnson and Johnson to conduct clinical trials in Ghana. Similar applications were made to Kenya, Tanzania and Uganda by Johnson and Johnson.

Mr. Speaker, the FDA derives its mandate for the regulation and approval of clinical trials from Part 8 of the Public Health Act of 2012, Act 851. Indeed, since 2004 the Food and Drugs Board (FDB) as it was then known, has built capacity to regulate and monitor clinical trials in Ghana.

Mr. Speaker, it is very important to note that since 2004, the FDA (or FDB for that matter) has dealt with 54 applications for clinical trials out of which 43 were approved. The other 11 applications were not approved due to insufficient evidence of safety and efficacy.

Out of the 43 approved clinical trials, 14 were for various types of vaccines, 26 were for drugs and 3 were for medical device trials. I hasten to add that most of the clinical trials conducted in Ghana over the years have been at Navrongo, Kintampo and Hohoe. I will come to this later. Mr. Speaker, it goes without saying that the FDA monitors the Clinical Trial Research Centres and performs pre-trial inspection of sites to ascertain suitability and capability for particular trials. The FDA has had cause in a few instances to take regulatory action including suspending trials, imposing fines, warnings due to non-compliance of Good clinical practice (GCP) and regulatory requirements under Act 851.

Mr. Speaker, owing to the enviable capacity which the Ghana FDA has developed over the years, it was nominated by the WHO to host and assist its counterpart organization in Sierra Leone to review a protocol for Phase 3 of an Ebola vaccine trial by Janssen which is a subsidiary of Johnson and Johnson. This meeting was held in Accra from 8-10 April 2015.

As recently as June 9th 2015, Ghana FDA provided similar advisory and capacity building support for a pending Phase II Ebola vaccine trial for Burkina Faso, La Cote d’Ivoire, Kenya and Uganda.

Indeed, it may interest you to note, Rt Hon Speaker, that the Ghana FDA has been designated as a Regional Centre for Regulatory Excellence with oversight responsibility for clinical trials as well as Medicines Evaluation and Registration in the sub-region.

Mr. Speaker, as I stated earlier, the first application received for Ebola vaccine trial in Ghana was in December 2014. The sponsor was Glaxo Smith Kline. This is a phase 2 clinical development trial with safety and immunogenicity in healthy humans in Ebola free countries as its main objective. Mr. Speaker, please permit me at this stage to venture into the world of biological science!! The vaccine for the proposed GSK trial is an Ebola glycoprotein gene. According to scientific information available to my office, when the vaccine is injected into healthy humans, antibodies against the Ebola virus will be produced which can lead to the prevention of EVD. The vaccine, according to the information available, cannot cause EVD since it does not replicate in humans due to deletion of its replicating gene. For the avoidance of doubt, this vaccine does not contain the Ebola virus. I repeat, this vaccine does not contain the Ebola virus and cannot cause the Ebola disease.

Mr. Speaker, countries involved in the proposed Phase II trial of the GSK vaccine are Ghana, Nigeria, Cameroun, Senegal and Mali. The rational for conducting the trial in Ghana and four (4) other countries takes into consideration the fact these countries border the affected countries. The design of the Phase II trial will be such that in the event of an outbreak persons already vaccinated would be already protected. Mr. Speaker, • The Kintampo Health Research Centre (KHRC), and • Onchocerciasis Chemotherapy Research Centre (OCRC), Hohoe have been proposed by the sponsors as prospective trial centres.

Right Honourable Speaker, we however have information that Phase 1 studies of the trial vaccine have been conducted with different dosages of the vaccine to assess its safety and immunogenicity in humans. These studies were conducted in • National Institutes of Health, Bethesda Maryland, USA • Oxford University in the UK • Centre for Vaccine Development in Mali

Mr. Speaker, the application by GSK is still under consideration. Nigeria, I repeat Nigeria, has however given approval for the trials.

Janssen Ebola Vaccine Trial

Right Honourable Speaker, the second application received by the FDA was from Johnson and Johnson. Incidentally the Principal Investigator selected by the sponsors is no less a person than our own Professor Binka. He won a competitive bid to conduct the study at his research site which is in the Volta Region, Hohoe to be specific.

Mr Speaker, permit me to give a brief history of the Hohoe Centre and why it has become a focal point of clinical trials in Ghana. The Oncho research center at Hohoe was started in 1986 by WHO. For nearly 30 years now, over 30 clinical trials including phase l, phase ll and phase lll studies of oncho drugs, malaria drugs and others have been conducted according to internationally recognized standards at the Hohoe Centre.

The current use of Ivermectin and other combinations of drugs recommended by WHO for all the Oncho affected countries was developed following trials at Hohoe The Research Center has collaborated with more than 20 reputable institutions including the WHO,UNICEF, The Noguchi Memorial Institute for Medical Research in Accra, The University of Ibadan, The National Institutes of Health in Maryland, The Liverpool School of Tropical Medicine and Center for Global Health & Diseases, Case Western Reserve University (USA)

Mr Speaker, Hohoe is an internationally recognized name in clinical research.

Mr. Speaker, permit me to state clearly that the process of choosing the researcher and/or research Centre to carry out clinical trials is the prerogative of the Sponsor and its agents. It is a competitive process and the sponsor chooses from among many applications. The FDA is only informed when the clinical trial application is submitted for technical review. Neither the Ministry of Health nor the FDA is involved in this process. The FDA and the ethics committee, in this case the Ghana Health Service Ethics Review Committee, however have to verify and ensure that the investigators are qualified to carry out the study and that the center is adequately equipped to conduct the study before approval. Following approval, the FDA then conducts Good Clinical Practice (GCP) Inspections throughout the trials to ensure that they are being conducted in accordance with current WHO standards.

Mr Speaker, the engagement of the community, including issues of compensation to participants, is the responsibility of the Researcher, and the FDA’s role is to ensure the researcher complies with what they have stated in their protocol and this can only happen after approval has been given by the FDA.

The monitoring and evaluation of the implementation of the study is carried out by the FDA and the Ethics Review Committee of the Ghana Health Service throughout and after the study.

Mr. Speaker, the clinical trial phase I of the Janssen Research and Development, subsidiary of Johnson and Johnson is to assess the safety and tolerability of its vaccine.

There are two vaccines involved: a prime and a booster vaccine, the combination of which provides protection against the virus.

Mr. Speaker, as I stated earlier, the countries to be involved in the proposed Phase 1 trial by Johnson and Johnson are Ghana, Kenya, Uganda and Tanzania and the decision to use the Onchocerciasis Chemotherapy Research Centre (OCRC), Hohoe for the Ghana Clinical trials was made by the Principal Investigator.

Mr. Speaker, I have sought to provide as much information as possible so as to give Honourable members and the good people of Ghana enough insight into the issue of the Ebola vaccine trials that has generated so much discussion.

Mr. Speaker, Part 8 of the Public Health Act 851 of 2012 does not ascribe any specific role to the Ministry of Health where clinical trials are concerned. I believe the framers of the law did so in order to isolate matters of scientific clinical nature from political control. Nonetheless, in the case of the Ebola vaccine trials, a different approach was taken bearing in mind the intense public fears of the Ebola disease.

In this respect, at the very onset, the FDA duly notified the Ministry of Health as soon as applications for Ebola trials were received. And here I refer to the application from GSK and Johnson and Johnson. It is on record that my predecessor and the Deputy Minister were both briefed by the FDA. The Deputy Minister was actually assigned oversight responsibility to monitor the processes. On my assumption of responsibility barely a month ago, I facilitated two roundtable meetings (precisely on the 4th and 10th of June 2015) which were called to discuss some concerns raised by some senior scientists and researchers.

Indeed, Mr. Speaker, the FDA Governing Board, concerned with public sensitivities surrounding the Ebola disease and fears that clinical trials of vaccine could generate among Ghanaians, and conscious thus of the need to be pro-active, set out a plan for stakeholder engagement preceding any formal approval for Ebola vaccine trials.

Mr. Speaker, I must concede that implementation of the programme for stakeholder consultations and community engagement has not been as thorough as one would have expected. Consequently I took the decision to announce the suspension of commencement of clinical trials to allow for adequate time to reach out and assure all concerned that under no circumstances will the Ministry, or the Government for that matter, approve of any clinical trials that will undermine the health and safety of residents of Hohoe in the Volta Region and the people of Ghana as a whole.

Mr. Speaker, I have noted the ongoing debate within the scientific community on aspects of the Ebola disease, including possible origins and vaccine trials. That ongoing debate is what drives scientific pursuits and discovery. What is of immediate importance is to build safeguards for vaccine trials even as we are guided by history. It is in our enlightened self-interest as a country to contribute to the global quest for an Ebola cure or vaccine.

Mr. Speaker, there are various ongoing studies and trials on Ebola in many places around the world. There is one study for instance, involving 59 people which began last November in the US, Canada, Germany and Gabon. We are told the vaccine was developed by the Canadian government and is licensed to two US companies.

The US National Institutes of Health has also reported that an Ebola vaccine is being tested in Bethesda, Maryland in the USA. Surely Mr. Speaker it will be sad to describe all those participating in the quest to find an Ebola vaccine or cure in other parts of Africa and in the distant places of Europe and North America as guinea pigs. Mr Speaker, from the foregoing, the following conclusions can be drawn.

1. Ebola is still a major public health, social and economic threat to West Africa in particular and Africa and the world in general. Until the last case of Ebola is found and dealt with, there is still a clear and present danger of spread.

2. The epidemiological history of Ebola in East and Central Africa points to the return of the epidemic even if this current wave is overcome. It will therefore be prudent for us all to do our part to find permanent medical solutions in the form of vaccines and medications to overcome Ebola, and to minimize its adverse effects.

3. Ghana has led efforts in West Africa to fight and defeat Ebola – by the examples of His Excellency President John Dramani Mahama visiting the three affected West African countries to break their isolation on 15 September 2014: His Excellency the President’s speech on 25 September 2014 at the United Nations calling for the world’s support and attention; and the hosting of UNMEER in Ghana. Finally, Mr Speaker, let us remember that Ghana contributed 42 health workers to the African health worker cadre that went to the three affected countries to assist in fighting the disease. We have to do our bit to support the development of a safe and efficacious vaccine against this disease, firstly because we will potentially be the greatest beneficiaries when the efforts are successful, as Ebola is now in West Africa, and also because the problem is now OUR (West African) problem, and we, more than most, should be concerned about finding a solution.

4. Mr. Speaker, I believe Ghana has the intellectual capacity, infrastructure and track record to support such a clinical trial – with demonstrable strength in governance institutions like this august house and the Ministry of Health, regulatory mechanisms like the FDA, and implementation and research – with numerous health research centers throughout the country.

Mr Speaker, for every clinical trial, there are potential risks, so we have to take that into account and make every effort to identify the risks early and abort the trial if need be. That is why the FDA has put in place extra measures, over and above the usual measures they employ, to make sure that in the event that this trial is to proceed, things do not get out of hand.

Mr. Speaker, it is clear from the debate in this august house and from reactions from Ghanaians as a whole, that there is some misunderstanding about the trial, the dangers it poses and its benefits to Ghana and the rest of the world. Ebola evokes fear, and discussions about the disease are emotive. Clearly, Ghanaians in general and the communities within which the trials have been planned were not sufficiently consulted and briefed about the trial. In order for this to be corrected, I am proposing the following steps 1. A nationwide public education programme will be initiated to sensitize the Ghanaian public on the nature of vaccine trials against Ebola to remove the misconceptions and suspicions. The sensitization programme will begin tomorrow Wednesday 17th June 2015 in Accra. It will afford members of the general public and the media the opportunity to interact with professionals on clinical trials. The venue and time will be communicated by the end of the day. But, Mr. Speaker, even before the sensitization starts let me state categorically that the trial has not started anywhere in Ghana.

Let me also state that we have not even given approval for the importation of any such vaccines.

And let me further state that no volunteers have been recruited for any of the proposed trials. Indeed the selection of volunteers in itself is a very rigorous process with a long drawn out protocol and safeguards.

2. Mr. Speaker, this sensitization programme will as a matter of urgency, be extended to Brong Ahafo, Volta and Upper East regions which usually host clinical trials.

3. Mr Speaker, on 15 July, I seek your permission to brief the Select Committee on Health of this august house on my findings and the outcome(s) of the community engagement. This will inform the decision on how to proceed to ensure that in the medium and long term, Ghanaians are safe from emerging diseases like Ebola.

4. Finally, Rt. Hon. Speaker, the Ministry of Health, under my leadership, will do what is right. We will do what has to be done to make sure that the good people of Ghana are protected. We will do what is right to ensure that in the medium and long term Ghanaians are safe from emerging diseases such as Ebola.

Thank you Mr. Speaker