21
Wed, Feb

ebola vaccination


  • Kwame Asiedu|myghanalinks
    - “Be sceptical, ask questions, and demand proof. Demand evidence. Don't take anything for granted. But here's the thing: When you get proof, you need to accept the proof and we're not that good at doing that.” Michael Specter

    Ever since the Ebola pandemic ravaged some countries in West Africa, many have questioned the commitment of the international community and pharmaceutical multinationals, as far as research and development were concerned. There have been many conspiracy theorist and other speculators who have opined at various times that these countries could even have a hand in the pandemic. These arguments were given credence when at the height of the outbreak, it was discovered that countries like the United States, Canada and Great Britain had stocks of experimental vaccines. The disparity in mortality rate amongst blacks and white (up to 90% in blacks and less than 5% in whites) patients was also ceased upon.

    Some of us had argued on the contrary, that there was no incentive or scope to attract investment into orphan disease drug research and that governments in the sub region ought to do more to incentivise research. We further criticised the sub regional government for the poor supportive care infrastructure. Last week it emerged that clinical trials of a potential Ebola vaccine were going to be carried out in Hohoe. I have been rather amazed at the negative press that this has received. In all honesty, I have a feeling this bad press is due to a lack of understanding.

    Like Noël Coward said in Blithe Spirit “It's discouraging to think how many people are shocked by honesty and how few by deceit.” Truth is clinical trials are an important aspect of pharmaceutical research, without which many important medicines will never had seen the light of day. Few trials have historically happened in Sub Saharan Africa even for diseases that are locally prevalent. Hence it is very common to find new medicines with Summary of Product Characteristics (SPC) making little reference to potential untoward effects in black populations. In effect the first black patients prescribed these new medicines become the guinea pigs. Information abounds regarding the bottlenecks that limit clinical trials in black subjects. There is considerable evidence that blacks are generally recruited for clinical trials at a lower rate. Cultural beliefs or myths about specific diseases or illnesses also cause black communities to generally frown on these experiments. Our society is one that has traditionally frowned on abstract thinking and preferred to deal with the tangible or mystique.

    Clinical trials are normally divided into four phases, but often preceded by a targeted trial where your doctor may ask if you are interested in experimenting on a new unregistered drug. This is termed a Phase zero studies. Phase zero studies usually only involve a small number of people and they only have a very small dose of a drug.

    Phase one trials aim to test the safety of a new medicine. A small number of people, who may be healthy volunteers, are given the medicine. Researchers test for side effects and calculate what the right dose might be to use in treatment (known as dose-ranging studies). This will usually be the first time the medicine has been tried on humans, so there's an unavoidable element of risk. To minimise the risk, researchers start with small doses and only increase the dose if the volunteers don't experience any side effects, or if they only experience minor side effects.

    Phase two trials test the new medicine on a larger group of people who are ill. This is to get a better idea of its effects in the short term and to ascertain whether treatment success is high.

    Phase three trials are only for medicines that have already passed phases one and two. They test medicines in larger groups of people who are ill, and compare new medicine against any existing treatment if there are or a placebo to see if it's comparatively better in practice and if it has important side effects. Phase three trials often last a year or more and involve several thousand patients.

    Phase four trials take place once new medicines have passed all the previous stages and have been given marketing licences. A marketing licence means the medicine can be made available on prescription. In phase four trials, the safety, side effects and effectiveness of the medicine continue to be studied while it's being used in practice. Phase four trials are not required for every medicine.

    From the above it is clear these processes are well thought through and have the requisite checks and balances. From all indications the trials in Ghana are Phase One, hence the use of healthy individuals. Much as I can understand the concerns of many well-meaning individuals and interest groups, I must point out that such trials are also subject to medical ethics committee guidelines. Often there will be local and international oversight. As a result clinical trials may last about four years on the average but in situations like Ebola are generally fast tracked. The reasons for fast tracking in my view are obvious; it will be sacrilegious to have another pandemic anywhere in the world without a vaccine in place. To me that will be the height of public health irresponsibility.

    Playing the devil’s advocate, I find it intriguing that on one hand we cry for treatments for diseases like Ebola but are not prepared to be experimented upon. As a people we seem to portray that we value or own lives more than any other race. Reading between the lines and protestations, I get the impression that we believe it is alright for these medicines to be tested in other countries but not ours. However should there be another outbreak of Ebola, we are entitled to receive these vaccines to save our lives. Is this not a sense of entitlement gone mad and the height of all hypocrisy?

    The argument that the students are being bribed with GH¢200 each and mobile phones is ludicrous to say the least. Worldwide, payments have always been made to participants in clinical trials both in cash and kind. There is also a top up payment for insurance just in case things go wrong. To see this as a bribe is a clear demonstration of a lack of understanding of life in the pharmaceutical research world.

    My only concern seems to be the impression that the nursing students being targeted for this trial are not volunteers but co-opted. This may fly in the face of medical ethics and could raise issues at the point of licencing should these trials be successful. I sincerely hope that this is not the case and would be surprised if it was, considering that last I checked; these trials had World Health Organisation backing. Truth is on this occasion I laud the Health Ministry and all involved in bringing this trial to Ghana. We can’t always have our cake and eat it, this is a worthwhile risk and I whole heartedly support it.

    • In a statement on Sunday, the World Health Organization said it wasn’t unusual for sporadic cases to occur following a major outbreak and that previous Ebola responses were already making it easier to deal with this one.

    Health officials in Congo confirmed another Ebola outbreak in the country’s east on Sunday, the fourth in less than three years. On February 3, a woman died in Butembo town in North Kivu province, Minister of Health Eteni Longondo announced.

    • "This advance will, in the future, help save thousands of lives that would have had a fatal outcome in the past."

    After 29 days at an Ebola treatment center in eastern Congo, fighting for their lives, a mother and her young son were discharged Tuesday amid applause and laughter.

  • The International Federation of Red Cross and Red Crescent Societies (IFRC) says the outbreak of Ebola in the Democratic Republic of Congo is “worsening” and has killed more than 1,000 people.

    • The Congo treatment trial, which began in November last year, is being carried out by an international research group coordinated by the World Health Organization (WHO).

    Two experimental drugs - an antibody cocktail called REGN-EB3 developed by Regeneron (REGN.O) and a monoclonal antibody called mAb114 - will now be offered to all patients infected with the viral disease in an ongoing outbreak in the Democratic Republic of Congo (DRC).

    • Ebola is transmitted by coming into contact with the bodily fluids of an infected person or contaminated materials. However, the early symptoms of fever and muscle aches resembles other common diseases like malaria.

    A patient has tested positive for Ebola in Abidjan, a city of more than 4 million people, marking the first case of the disease in Ivory Coast in more than a quarter century, the World Health Organization said.

    • More supplies of vaccines are required to roll out immunization across a wider area.Those pushing for the use of the new Johnson & Johnson vaccine, ....

    Written By Dr. Edward O. Amporful - As I write this piece, the Democratic Republic of Congo (DRC) is reeling from an Ebola crisis with the World Health Organization (WHO) having declared it a global health emergency. It is reported to have killed about 1,800 people so far. The crisis has been worsened by internal conflicts and mobility of people fleeing from the conflicts. I will continue with information gleaned from the BBC and Bloomberg on the Ebola crisis and deployment of vaccines.

  • Written By Charles Neequaye - At a time the deadly Coronavirus pandemic is at its peak and causing a lot of havoc in the country, news filtering in from neighbouring countries indicate that on the sideline, the deadly Ebola Virus Disease (EVD) is knocking on our doors asking permission to enter.

    • "The approval of the Ebola vaccine by these countries is another milestone in the fight against this unforgiving disease," said WHO Director General Dr Tedros Adhanom Ghebreyesus.

    The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have licensed an Ebola vaccine, just 90 days after World Health Organization (WHO) prequalification. Registration of the vaccine is expected in additional countries in the coming weeks.


  • Kwame Asiedu|myghanalinks - As societies grow decadent, the language grows decadent, too. Words are used to disguise, not to illuminate, action: you liberate a city by destroying it. Words are to confuse, so that at election time people will solemnly vote against their own interests.” Gore Vidal.

    In recent times there has been a raging debate on the benefit and risk analysis of an impending trial for a potential Ebola vaccine. I have worried about some of the information that has been bandied in print, electronic and social media and the near confusion and acrimony that has surrounded this debate.
    In today’s world, development costs for new biological agents are increasing, and the time span from laboratory research to introduction of a product on the world market is becoming longer. Sadly for certain diseases that affect very small populations, incentives have not warranted investment by multinational pharmaceutical companies.

    This led to the introduction of what is known as the orphan drug policy; Orphan Drugs refer to pharmaceutical agents that are developed specifically to treat medically rare conditions. To develop these pharmaceutical agents, governments often have to provide incentives. The intervention by government on behalf of orphan drug development can take a variety of forms: tax incentives, enhanced patent protection and marketing rights, clinical research financial subsidization etc. In October 2014, at the peak of the Ebola pandemic, the European Medicines Agency (EMA) in conjunction with the Food and Drugs Authority (FDA) of the USA and the Medicines and Health Products Regulatory Authority (MHRA) invited applicants for an Ebola vaccine search under the umbrella of Orphan Disease guidance. This officially blew the whistle for competition amongst multinational pharmaceutical companies and leading researchers in tropical diseases in an area that hitherto had become dormant.

    Such pharmaco-medical research races are extremely competitive and shrouded in secrecy, though all groups ultimately aim at obtaining a vaccine and or treatment. There are confidentiality clauses and non-disclosure arrangements at each point to prevent leakage of intellectual property. Most scientists see these as a date with destiny. Contracts between researchers, lead investigators and pharmaceutical companies in respect of intellectual property arrangements are strictly confidential and often not disclosed. This is what has brought us to the point where some of these potential vaccines have been and continue to be tried in humans and have been licensed in many other countries across the Globe.

    Applications for a licence to undertake clinical trials are often made in the appropriate manner to the statutory drug regulator in the country, in the case of Ghana, the Food and Drugs Authority (FDA). The information is then shared with the Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC) of the health authority, in the case of Ghana, the Ministry of Health. The applicant is not allowed to publicise the contents of their application or educate prior to approval.
    The application process is covered by confidentiality clauses where the regulator cannot divulge information regarding any applications received. It is therefore disingenuous to blame the FDA for lack of education.

    It is obvious from the above that the applicant and regulator had their hands tied as far as sharing information with the public was concerned. My belief is that aspects of the vaccine dossier and or communication between the parties were leaked, resulting in information getting into the public domain. Sadly the applicant and local researchers could not help but abide with international laid down conventions, much to their own disadvantage. The reality of this compliance is on the basis that the companies undertaking the trials are also bound by guidance of the ethics committees in their own countries.

    I explained previously, the stages of clinical trials and would want to make one distinction that pertains to experimental vaccines. Vaccine trials differ from conventional drug trial in that, in a vaccine trial one does not work with diseased individuals. The notion that if one wants to undertake an Ebola vaccine trial, he requires diseased patients is incorrect for a Phase I and Phase II studies, where studies are conducted to test the safety of the product and whether the product being tested can induce an immune response in recipients. Sadly this has been the main contention of most commentators.

    As a result of a request by the World Health Organisation for a fast-tracking of the vaccine production, Johnson and Johnson approached countries known to have good infrastructure for clinical trials. The criterion set included, the presence of an independent and strong ethical review board, an independent regulatory authority, qualified staff with a good knowledge of clinical trials, research ethics and Good Clinical Practice. Countries selected included Kenya, Mali and Ghana in Africa, Australia, the United Kingdom and the United States. The researchers involved in this trial locally are also world renowned, so is Noguchi Memorial Institute, the local research partner.

    In my view with such a high bar set that, Ghana made the list is even a feather in our cap. Unfortunately with the way things are going, we ran the risk of blowing it all up. Issues of human security and public health are taken seriously by the World Health Organisation and are often left to the experts. They are not matters for public debate as has been experienced in Ghana and continue unabated. Truth is pharmaco-medical research has consistently tried to stay independent of politics. In contrast anything Ghanaian is viewed through a political lens.

    We are always calling for Independent state institutions devoid of political influence, yet when it suits us we are the very ones who cause politicians to intervene. From radio stations who invited politicians and not public health researchers or experts in medicines and health product regulation to speak on the subject matter, to constituency activist who eventually managed to get the speaker of parliament to usurp his powers and call for the trials to stop; all acted in flagrant contravention of all international protocols governing pharmaco-medical research.

    Truth is anytime we take our children to hospitals for a vaccine, let us remember that once upon a time; there were volunteers in the midst of health populations from whose risks we reap benefits and accrue long life. The world has been here before and flinched in the early days of Ebola, when only 400 people were affected because public pressure botched a vaccine trial making it convenient for the world to walk away. Today affecting nearly 40,000 people, as a country we are at the verge of flinching. Is this what the forbearers wished for us? With or without Ghana these trials will continue in other selected countries and hopefully a vaccine will be found. However as a country we should be mindful of the potential collateral damage we are doing to our pharmaco-medical research potential and the reputations of some world renowned clinical researchers who happen to be Ghanaians.

    The rumours being spread that the vaccine contains the virus are unfortunate, sometimes ignorant and in some cases mischievous. Let it be known by all that the potential vaccines currently undergoing clinical trials in other countries and for which an application has been granted but suspended in Ghana, does not contain the virus, neither is it attenuated. It is a recombinant antigen extract that has the potential of inducing antibodies in humans thus conferring immunity from Ebola.

    Like the proverbial vulture, we are waiting for the next Ebola pandemic only to turn to WHO and the international community in our trademark begging fashion, to demand with our egoistic false sense of entitlement the very vaccine we fought so hard to destroy. My views about the Food and Drugs Authority, (FDA), Ghana are well document and known but I am also man enough to stand and applaud when the right thing is being done. It is in this vein that I have backed the actions of FDA, Ghana, on this occasion and deplored the ugly noises.

     

     

     

     

    • In a study published Tuesday in the journal Cell Reports, the scientists said the approach could be used for Ebola and other newly emerging deadly diseases caused by viruses.

    Scientists working on developing vaccines against Ebola have found they can "harvest" antibodies from volunteers vaccinated in research trials and use them to make treatments for the deadly viral infection.

    • Last month WHO said Tanzania had refused to provide detailed information on suspected Ebola cases.

    Tanzania denied Thursday it was withholding information from the World Health Organization (WHO) on suspected cases of Ebola, saying it was not hiding any outbreak of the deadly disease in the country.


  • Written By Kwame Asiedu - “Since man cannot live without miracles, he will provide himself with miracles of his own making. He will believe in witchcraft and sorcery, even though he may otherwise be a heretic, an atheist, and a rebel.” Fyodor Dostoyevsky, in The Brothers Karamazov.

    RECOMMENDED: HUMAN SECURITY AND PUBLIC HEALTH; THE SEARCH FOR AN EBOLA VACCINE

    RECOMMENDED: CLINICAL TRIALS; A DATE WITH THE WORLD OF MEDICAL AND PHARMACEUTICAL GAMBLING  


    In the past week Pharmaco-medical research announced two important public health breakthroughs. These put together are probably the biggest health contribution to Africa in recent memories. There was initially the announcement of a vaccine for malaria, then the big one from Glaxo Smith Kline about a vaccine for the dreaded Ebola. International media was awash with reviews upon reviews from expert principal investigators and officials of the World Health Organisation. The spotlight was on countries that had made significant contributions to these two feats. Ironically the fanfare that greeted this was not marked in Ghana, the country of my birth for obvious reasons.

    Truth is before these announcements we had gone down as a country that sort to hold the world to ransom in its quest to find a vaccine for Ebola. Thanks to some intransigence and rather bizarre statements on the floor of our legislative house, Ghana had put himself on the map as a medical research laughing stock. We had caused so much unnecessary international panic that the WHO dispatched its Deputy Director General, Dr Anarfi Asamoa-Baah (a Ghanaian) to meet His Excellency John Mahama in an effort to try and bring some sanity into the system. Whilst this was going on some who we as voters had queued in the sun from dawn to dusk and elected into parliament were being infantile. Behaving in a manner akin to kids whose prized toys had been taken away, they shouted themselves hoarse claiming a citizen who many of them couldn’t hold a candle to had impugned on their integrity.

    Conducting what could best be described as a North Korean style show trial aimed at score settling and ultimate execution, they extracted an apology and patted themselves on the back. Whilst they were making a mockery of their august house, the world was busy passing Ghana by. Yes they were busy putting the final data together under the coordination of the World Health Organisation Vaccine programme chaired by a certain Prof, Alexander Dodoo. On the 31st of July 2015 the ultimate announcement was made a vaccine that gave 100% protection to contacts of infected Ebola patients had been found. A quote from that announcement by Margaret Chan, the Director General of the WHO almost made me cry. It reads “The credit goes to the Guinean government, the people living in the communities and our partners in this project.” Such pride is what any country’s leadership and citizens crave for. Such statements give immense credibility to a country and prove that it can punch well above its weight. Imagine if the country in this quote was Ghana? Imagine the amount of medical research finance and goodwill it would have generated?

    Sadly the sycophants we elect were more interested in their supposed bruised egos because ostensibly someone had dared to call them IGNORANT and tell them to SHUT UP!!!! In my short sojourn through this life, it’s only in Ghana that some misguided few hear SHUT UP and think it’s an insult. In the end they managed to derail the start of Phase II trials in Ghana but not to halt the world’s momentum and march towards breakthrough vaccine research.

    Some brave men had decided to be the trail blazers they had chosen to be like Antwi Boasiako; putting their lives on the line in an effort to save human kind. Their names are now etched in history. One such person is Mohamed Soumah, 27, the first person to be vaccinated with the new "most effective Ebola vaccine" in the Guinea trials. On the WHO website, he is quoted as saying, “It wasn’t easy, I can’t say I wasn’t afraid, I was afraid. People in the village were saying that the injection was to kill me. I was the first one to be injected, the very first, here in my village on March 23. 44 people were vaccinated. I had fever and I bled after the vaccination, it worried me a bit, but they warned me that would happen and it didn’t last long. I’ve been monitored for three months and I’ve had no problems. The last follow up, 84 days after the vaccination, was all clear”.

    Truth is the thought of Ebola scares the hell out of anybody. However in other countries the quest for a vaccine far outweighed the selfish interest of a few. Compare the behaviour of Mohamed Soumah to the actions of some from the Hohoe municipality and the Volta region parliamentarians. Clearly Mohamed was looking at the bigger picture, whilst the Volta parliamentarians were thinking about the next election. It is this sort of stupidity that often drives this country close to the cliff.

    As I type this, doctors in Ghana are on strike, it is clear that the risk to the citizenry is close to home. There is a real possibility that people could die and as usual many are trying to appeal to the good conscience of these doctors to return to work. Even under these circumstances, the country is split right through the middle; with some playing the usual politics with a rather delicate issue. However one thing is clear, for fear of death, we all want these doctors back to work. However when it came to deaths that affected others, thanks to Ebola; as a country we flinched. Yes Ebola was too far away for us to be bothered. Some went as far as suggesting people who volunteered for the trial should be banished from their communities.

    In one of my many writings on this subjects I suggested that my hope was that should a vaccine be found, we don’t behave as the beggars we are and request for stocks from the WHO and producing companies. My gut feeling is that we would; without any shame we would expect the world to forget about the shenanigans of our parliament and treat Ghana as a special case i.e. the jewel in the crown and provide us with stocks ahead of any other country. It is this high sense of misplaced entitlement and hypocrisy that allows our parliament to approve loans that are tax payers money of other countries, whilst unable to fashion a way towards governments fiscal discipline. WE MUST BE ASHAMED OF OURSELVES.

    Like Jim Butcher opines, “Evil isn’t the real threat to the world. Stupidity is just as destructive as Evil, maybe more so, and it’s a hell of a lot more common. What we really need is a crusade against Stupidity. That might actually make a difference.” I must say this crusade must be led from within Ghana’s Parliament and I make no apologies for saying so. With the sort of money we pay them, such failings when information can be gleaned in confidence cannot be allowed.

    But don’t be down hearted my fellow Ghanaian, be gladdened by the fact that when the history of Ebola vaccine discovery is written, it would be noted that it was made whilst a certain Prof Alexander Dodoo was chair of the World Health Organisation Vaccine Programme and that he was a Ghanaian. The case of the stone that the idiot builders rejected would have been well and truly written. Hopefully, haven learnt our lesson; in 2016 many waste pipes from across the political divide would be chased out of our parliament. It is only then that the crusade against stupidity would have well and truly began.

    • The Oxford/AstraZeneca vaccine is one of 150 in development globally, but is considered the most advanced. Late-stage trials have begun in Brazil and South Africa and are due to start in the United States, where the infection prevalence is highest.

    Early data from trials of three potential COVID-19 vaccines released on Monday, including a closely-watched candidate from Oxford University, increased confidence that a vaccine can train the immune system to recognize and fight the novel coronavirus without serious side effects.

    • On Sunday, the first case of Ebola was discovered in Goma, a city of 2 million. The pastor infected with the virus later died.

    The World Health Organization on Wednesday declared the Ebola epidemic in the Democratic Republic of the Congo's conflict-ridden North Kivu and Ituri provinces a public health emergency of international concern.

  • Heavily criticised for its response to the 2014-16 Ebola epidemic, the WHO is now on the front line in dealing with the emergence of new cases in DR Congo. It says that it is preparing for the “worst case scenario”.

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