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

QUESTIONS ON MY MIND THIS MORNING I was also wondering about the cultivation and export of cassava chips. Wondering if its still a high priced commodity as it used to be back in the day. Do you know of any form of assistance offered to agri-business and how one can access it? Do you also know how to go into Nutmeg cultivation and would be glad to get some information on persons already into its cultivation. THis is what is trending on my pages and people are asking. I ask you guys to broaden your horizon on and think about questions that people will be interested in asking. Is there an Agric information bureau in Ghana? Do you guys know how to get information on Agric in Ghana?

Agric extension policy framework under review

Very well spoken by the Director of Agric. My question is why the decentralization system of the MOFA has not been effective so far. People are afraid to take decisions because of too much power given to people in authority who also do not take the decisions. Each time someone has to take a decision they have to cross-check or you have to write a letter or proposal before you are given the green light. So many students are sitting at home who can be used to support extension work. We need to be bold as a country and solve the problems in the field not at workshops. Too much talking and very little action. What is being done should be visible and understood by all. Most of all by the farmers who are actually going about their everyday livelihoods......FARMING. They need the support not the talk. There are so many young people losing interest in farming because it is just too much work even trying to get land to start a farm. Too much work trying to get financing to start a farm.. what is all the plenty talk about. Dr. Kwame Amezah, Director, Directorate Agriculture Extension Services (DAES), has observed that considering the current decentralisation system of the Ministry of Food and Agriculture (MOFA), steps must be taken and all efforts harnessed to ensure efficient coordination at all levels and ensure effectiveness and sustainability. “It is therefore believed that if local governments take responsibility for extension, as they are closest to the grassroots, farmers’ needs could be better met. This is on the basis that extension staff are localised, conversant with farmers’ needs, and will be able to facilitate extension activities more effectively.” Dr. Amezah, who read the keynote address on behalf of the Chief Director of MOFA, Mr. Joseph Boamah, at a two-day Agriculture Extension Policy Forum this week in Accra, said DAES has played significant roles through various initiatives such as Training and Visits (T&V), Participatory Technology Development and extension (PTD&E) and Farmer Field Schools among others, in empowering farmers to carry out their farming activities in a more effective, business-like and sustainable manner. He said the subsistence nature of most Ghanaian and African farming, and the cost of extension services, leads to a much stronger case for state intervention in support of food production. He stated that the need for a well-articulated and comprehensive Agricultural Extension Policy cannot be glossed over. “It is the bedrock on which the development and advancement of the agricultural extension can be well defined, approaches and functions well spelt-out; and the importance of such a policy is further buttressed by a statement made by the Food and Agriculture Organisation of the United Nations’ (FAO) Consultation on Agricultural Extension (GCAE) held in Rome in December 1989, where it was recommended that all national governments should develop and periodically review their agricultural extension policy.” Amezah noted that issues such as geographical coverage, target beneficiaries, staffing, funding and sustainability will be easy to examine and address if such a framework exists. He however added that global and regional experiences suggest that extension services are demand-based and market-driven, incorporating private sector as well as government and non-governmental resources. The forum was a collaboration of MOFA, the Modernising Extension and Advisory Services (MEAS) Project and the USAID/Ghana Feed the Future Agriculture Policy Support Project (APSP), and was aimed at creating a platform for stakeholders from the public, private and civil society sectors to come together and share experiences and expertise toward making efforts at improving agricultural extension delivery in the country. MEAS is operated from the University of Illinois at Urbana-Champaign in the United States of America, with funding from the USAID. The MEAS project has been approved for a multi-part work-plan to work toward strengthening extension and advisory services for farmers in northern Ghana. APSP aims to increase capacity for the Government of Ghana, the private sector and civil society organisations to implement evidence-based policy formation, implementation, research and advocacy; and perform rigorous monitoring and evaluation of agricultural programmes implemented under the Medium Term Agriculture Sector Investment Plan (METASIP). Dr. Paul McNamara, Director of MEAS, said before the break-up session that policy is central to extension and that MEAS has been working to strengthen agriculture extension services over the past five years in the country, and is consequently interested in the policy framework for extension services.

Govts should invest more in Agriculture

This story below is culled from the DAILY SABAH. The story intrigues me because one can liken the same situation in a lot of African countries where Govts always seem to exaggerate what is happening or specifically their achievements in the Agric sector. They do not invest much and yet expect a lot. They use all the wrong or outmoded policies yet expect it to work. Subsidies that must go out to help farmers are usually not given because donors say so and where they are, they are either provided very late or at the wrong time. I see from the statistics provided that TURKEY IS EVEN DOING MUCH BETTER THAN MOST AFRICAN COUNTRIES AND AT LEAST THEY HAVE DATA THAT IS READILY AVAILABLE. Food production really should be one of the main concerns of any Govt and leaving it to chance cannot be the way to food security. I was invited recently to a forum and the minister of Agric walked in and didn't even look at products that Ghanaians had displayed....He was rather interested in the foreign products of the other country. Agriculture should really be left for farmers, the experts, researchers etc. and not politicians Although officials have been talking about a major leap forward in agricultural production in Turkey since the ruling party first came to power, the recent plummeting of food prices indicates that the country's agriculture is besieged by many problems. Mehdi Eker, minister of food, agriculture and animal husbandry, recently boasted that Turkey ranks seventh in the world in terms of agricultural production, but the picture is not as rosy as the minister would have us believe. A recent statement by a leading representative of the agricultural sector reveals that the government must change its agricultural policy. In the statement, released at the beginning of the past week, the Chamber of Agricultural Engineers (ZMO) said: “As a result of agricultural policies that the [ruling] AK Party [Justice and Development Party] government has persistently sustained in accordance with [norms set by] global powers, our farmlands have shrunk by around 2.7 million hectares over the last 10 years. The amount of land that our farmers have given up to cultivate is about the size of the European country of Belgium.” Prime Minister Ahmet Davutoğlu boasted at a meeting of the Turkish Union of Agricultural Chambers (TZOB) last weekend that Turkey is Europe's biggest agricultural producer, with the revenue from its agricultural production last year having reached $61.3 billion. Eker pointed out, in a May 14 statement issued on the occasion of World Farmers' Day, that the government would give farmers a total of TL 10 billion ($3.8 billion) in subsidies this year. But the government has been much criticized by the opposition, which says that if the subsidies offered to farmers had been sufficient, they would not have stopped cultivating a significant portion of the country's land. The agricultural subsidies provided by the government to farmers amounts to about one-half of 1 percent of the gross domestic product (GDP), but it should really be as high as 1 percent, according to a law on agriculture introduced in 2007. “The subsidies provided to agriculture in 2014 should have [actually] been TL 17 billion. You are entitled to bigger [subsidies],” Kemal Kılıçdaroğlu, leader of the main opposition Republican People's Party (CHP), told farmers' representatives at last weekend's TZOB meeting. He suggested that the farmers would win their case if they were to take the issue to court, underlining that the financial aid transferred in subsidies to the sector is well below what it should be. The country's agricultural exports, valued at around $4 billion in 2002 when the ruling AK Party came to power, increased to $18 billion last year. Minister Eker also stressed in his statement that Turkey has become a net exporter of food, but the country's imports in agriculture have also skyrocketed. According to the CHP leader, who said farmers were paid TL 9 million ($3.5 billion) in subsidies in 2014, Turkey paid TL 350 billion ($135 billion) in imports in food and agricultural products. Noting that Turkey last year paid TL 44 billion ($17 billion) for imports in food and agricultural products, the CHP leader said at the meeting: “This is exactly five times higher than the subsidies [for 2014]. If Turkey had been governed intelligently, this picture would be in reverse.” “If they [the government] had paid half this amount to farmers [in subsidies], I assure you that we could have raised enough food to sustain not only Turkey but also the Middles East,” the CHP leader explained. The yearly cost of Turkey's agricultural imports has risen more than four times since the AK Party came to power in 2002, suggesting that the country's performance with regard to self-sufficiency in agricultural production is on the decline. While the amount of money Turkey paid for imported agricultural products was $1.69 billion during 2002, it totaled $8.62 billion between April 2014 and March 2015, rising by a dramatic 409 percent. Turkey's imports in food products last year reached more than $5.6 billion, Şemsi Kopuz, the president of the Federation of Food and Drink Industry Associations of Turkey (TGDF), said at a press meeting last month. According to official data, Turkey imported agricultural products from 153 countries in 2014. Bahrain, Belize, Cambodia, Djibouti, the Dominican Republic, Iceland, Jamaica, Kuwait, Luxembourg, Mali, Mauritania, Nepal, Niger, Papua New Guinea, Paraguay, Qatar, Rwanda, Senegal, Somalia, Surinam, Venezuela and Zambia are among the countries which have been added as import partners of Turkey for agricultural products over the years. The sharp hike in recent months in the prices of certain food products, which is not surprising given that farmers have given up farming a sizable portion of land in the past 10 years, also indicates problems waiting to be resolved in agriculture. Unusually high potato prices -- as much as TL 5 ($1.9) a kilogram -- have made the news at various times in Turkey this year. The government pins the blame on speculators, vowing that it would fight against the stockpiling of food. Potato prices have as much as tripled since last year. Stockpiling is generally conducted by middlemen who withhold large quantities of produce, only to release it on the market when prices increase. The opposition also indicates that the share of agriculture in national product has diminished by half since the ruling party came to power.

South Africa: Fear Grips Foreigners in Johannesburg

Lord help us....is this the Africa Kwame nkrumah envisaged. Did we not use our hard earned money to support their freedom and independence so that we could unite and be one. What a shame. I hope that these South Africans doing this realize that their citizens are also foreign nationals in other countries. It is indeed a very sad moment for Africa. President Zuma yes! not all south Africans are xenophobic but this situation could have been better managed if you paid more attention to the plight of the indigenous South Africans who are doing all of this because of the hardship they are going through and think that foreigners have taken over their jobs. a lesson to all African leaders. stop stealing our money and enriching yourselves and rather raise the standard of living of the suffering masses in your countries. Story from Al Jazeera Twelve people have been arrested, with anti-foreigner attacks in South Africa spreading to parts of Johannesburg's commercial hub, according to South African police. Police fired rubber bullets into a crowd of South Africans in the city's Jeppestown area on Friday. A crowd of South Africans carrying hammers and axes gathered near the city centre, chanting "Foreigners must leave." The arrests, made overnight, came as groups of South Africans who had gathered in Jeppestown and Cleveland blocked roads with rocks and burning tyres and then ordered foreigners to leave the country, police said. Jeppestown and Cleveland are neighbourhoods adjoining the Johannesburg Central Business District (CBD). A number of shops in the CBD were reported to have been looted and vandalised, further escalating tensions between foreigners and South Africans in Johanneburg. Police said the suspects were trying to break into shops owned by foreigners. Colonel Dlamini, police spokesperson, told Al Jazeera calm had been restored, but refused to reveal whether police had received credible reports of further threats of violence against foreigners in the city. Violence targeting immigrants started earlier in April in the port city of Durban, claiming the lives of six people so far. Rumours circulating Rumours of imminent attacks on foreigners have continued to affect foreign nationals in Johannesburg. Ahmed Fifa, a 35-year-old shop owner in the Ramaphosa settlement east of Johannesburg, said foreign nationals were warned by locals to vacate the area on Thursday night. "One of the community leaders came to us and told us to move all our stuff and save our lives," he said. According to Fifa, the South Africans in Ramaphosa are divided between those who seek to protect foreigners and those intent on violently driving foreigners out. "I can't go back until the situation remains stable," Fifa said. "I have seen the pictures of what happened in Durban and I need to save my life. "The only problem we have here is the xenophobia." In Durban, where six people have been killed in the last two weeks of violence against immigrants, police spokesperson Jay Naicker a fragile calm had been maintained on Friday. "Overnight we had no reported incidents and it has been calm," Naicker said, adding that the police had not received reports of further threats against immigrants in coastal city. He said foreigners would still not be re-integrated into the affected communities. "The area is still tense and the police and security deployment will remain for a while," Naicker said. Amir Sheikh, the chairperson of the Somali Community Board based in Johannesburg said the violence in Durban has inflamed tensions between South Africans and foreigners. "Some of our members have been harassed in Johannesburg following the violence in Durban." Late on Thursday a widely disseminated text message claimed that "a train of Zulus" had departed for Johannesburg. "These men are armed and they are going to be killing any foreigner they meet tomorrow." The source of these messages remains unclear, but their proliferation has sowed panic and confusion among migrant communities. "Our members have been unable to go about their day-to-day businesses because each time they open their businesses, a new message is received saying members of a certain ethnic group are gathering to attack them," Sheikh said. While these rumours have so far, proven to be false, its effects have already been felt. Foreign owned stores around Johannesburg have been closed for at least two days already. "The unfounded rumours have caused more damage to our members than anything else," Sheikh said. On Thursday South African President Jacob Zuma and leaders of the opposition in parliament spoke out against the violence against foreign nationals. Zuma said that the majority of South Africans were not xenophobic. "We reiterate our view that South Africans are generally not xenophobic," he said. "If they were, we would not have such a high number of foreign nationals who have been successfully integrated into communities all over our country, in towns, cities and villages." This story from Al Jazeera was supplied to AllAfrica under an agreement with the African Media Agency.

Xenophobic attacks in South Africa

Disappointed about what is happening in South Africa....the xenophobic attitude and the gruesome attack and murder is just simply shocking!!!!. What is happening in Africa! have some of these countries forgotten how these same people coming from other countries came to their aid in the darkest periods? They contributed massively to their freedom and independence. I am indeed very saddened Source: Rainbow Radio 87.5fm An appeal has been made to the Government of Ghana headed by his Excellency President John Dramani Mahama to as a matter of urgency evacuate the thousands of Ghanaians domiciled in South Africa. Some members of the Ghanaian Community in that Country who expressed fear and frustration said their lives are in danger due to attacks by locals. The International media has since Monday reported of xenophobic attacks by some youth of South Africa on other African Nationals in some parts of the country. The reason for theattacks is that foriegners seeking greener pastures have taken over their jobs. Speaking to Kwame Tutu, breakfast show host of Rainbow Radio 87.5fm from Johannesburg, a number of Ghanaians who said they have gathered and locked themselves up in one house, made a passionate appeal to the government to help get them out of the country. Asked if they have tried contacting the Ghana High Commission in South Africa, the Ghanaians caught in the troubles said little is done by the Commission to support Ghanaians who find themselves in any kind of trouble. Heart wrenching photos and videos of the attacks are trending on various social media platforms.

The future of Agriculture

From the story below one cannot help but think that there is a much bigger picture than this where the future of Agriculture in our country is really at risk. Is there a future for the Next generation of innovative farmers? Yes! the reasons below might be a huge factor in the region being spoken about but on...but at the National level the youth are losing interest in farming because its nor rewarding. There is no plan to keep those young farmers who are struggling now and certainly no plan to make those in school now even keen about farming. What are the national plans? In other developed countries serious efforts are made to protect farmers, guarantee their products, there are subsidy's, there is a financial and insurance plan. Our Govt is simply too slow and doesn't seem to have any clear plan that one can follow that assures up and coming young ones that farming can guarantee your future. I pray that our leaders begin to look carefully at this aspect if we want to ensure continuity and the future of farming and food production sustainability. Miss Victoria Adongo, a Programme Coordinator of the Peasant Farmers Association of Ghana (PFAG), on Thursday urged peasant farmers, especially young farmers in the Western Region, not to abandon their farms and fishing, for menial jobs in the oil industry. She said the region could experience food insecurity because of the rush investors were buying arable lands for estate development and fish output had decreased as a result of the oil rig. Miss Adongo made the call at a day's civil society analysis workshop on the 2015 budgetary allocation to the agricultural sector, organized by the PFAG, with support from the Open Society Initiative in West Africa (OSIWA) in Takoradi. She appealed to farmers and district departments of Agriculture, to promote small-scale Agriculture in their areas, and to ensure District Assemblies make adequate budgetary allocation for their development. In a press release signed by Mr. Charles Nyaaba, a Programme Coordinator of PFAG, the Association appeal to government to place a moratorium on the passage of the Plant Breeders’ Bill, while creating the platform for small-scale farmers and other stakeholders to address public concerns on the Bill. The Association urged government to ensure that the Bio-safety Authority is put in place, to actively monitor the activities of the National Bio-safety Committee public. “We call for direct dialogue between the Parliamentary Select Committee on Constitutional and Legal Affairs and the PFAG to address the concerns of small scale farmers including the traditional rights to select, store and share seeds”, it said. The Association said if its plea is not heeded by Parliament, it would continue to use all legal opportunities available to make its position known to the Ghanaian citizenry. “We will have no option than to call on farmers, traditional authorities, faith-based organizations, civil society organizations and consumers in general, to draw their attention on the dangers in passing the Plant Breeders’ Bill as it stands”.