Should Ghanaians take part in COVID-19 vaccine studies?
As efforts intensify in and outside Ghana to deal a deathblow to the COVID-19 pandemic across the globe, the search for a lethal weapon in the form of a vaccine has been moved to the front burner as part of the public health emergency response by the World Health Organisation (WHO) and other stakeholders.
A flurry of activities including pre-clinical studies are currently taking place in different research institutions in developed economies, with the backing of various governments across Europe, Asia and the US to secure a vaccine before the end of this year.
Some of the vaccine developers leading the global search are the Beijing Institute of Biotechnology, Osaka University, University of Waterloo, University of Oxford, Janssen Pharmaceutical Companies, DZIF-German Center for Infection Research, Centro Nacional Biotecnología (CNB-CSIC), Spain, the National Institute of Infectious Disease, Japan, University of Pittsburgh, Sanofi Pasteur/GSK, University of Queensland, University of Western Ontario and the Imperial College London.
Bloomberg has just reported that the Oslo-based Coalition for Epidemic Preparedness Innovations is funding nine different coronavirus vaccine projects and has previously suggested a shot could be ready within 12 to 18 months.
Although, the list of vaccine developers is not exhaustive, however, majority of governments in Africa and their research institutions appear to be missing in the current list of vaccine developers, researchers, funders and sponsors of clinical studies into coronavirus vaccines.
It may perhaps be that African institutions and governments are waiting on the sidelines to see the outcome of these global efforts. If this is not the case, then why are most of these COVID-19 vaccine trials taking place outside of the African continent, although there are capable research institutions and researchers in Africa who could come on board get a vaccine for the pandemic, since almost every country is being battered.
An uncomfortable quandary?
Is it an issue of funding, risk, timing, political or socio-cultural considerations? Or is it an ethical dilemma that may be keeping some countries away from making some moves towards joining the global clinical trials currently taking place?
A senior policy advisor explained that “many countries and institutions prefer to get involved at a later stage, rather than engaging in first-in-human-studies.”
“We are still a way off from larger-scale later stage trials, and there could be some African sites then,” she added.
Mrs. Lois Privor-Dumm, Senior Advisor, Policy, Advocacy & Communications, Director, Adult Vaccines, International Vaccine Access Center (IVAC), Department of International Health, Johns Hopkins Bloomberg School of Public Health said these in response to a series of questions from ghanabusinessnews.com, contained in a questionnaire.
No doubt that preparing for an opportunity to take part in any vaccine studies linked to the coronavirus disease is very important. This should be of concern for developing countries such as Ghana because should there be some positive results from studies going on, it is mostly likely that the populations in the developed economies, who are the major funders and sponsors of majority of these studies, would be the first beneficiaries of the world’s first potent anti-COVID-19 vaccine.
Shouldn’t countries such as Ghana be preparing for the possibility of becoming part of the COVID-19 vaccine research?
According to Mrs Privor-Dumm, African countries such as Ghana could still play a role in a later-phase trials or once a vaccine is licensed to “add to the understanding of how the vaccine works in settings that may have very different conditions from other sites.”
Drug and vaccine development generally involve about four phases. These are phase I, II, III and phase IV and these phases begin from the pre-clinical stage conducted on animals, to few human volunteers for safety, then trials involving larger patients to assess for efficacy and side effects and then over time the drug or vaccine, after approval and in use on the market, is tested under a phase IV clinical trial, also known as post-marketing trial.
Mrs Privor-Dumm noted that it is important that any studies that are done in Ghana and other African countries are done “transparently and that the population and policy makers are fully aware of what will be involved.”
She responded to a question on how Ghanaians should respond to the possibility of a COVID-19 vaccine trials, especially when a few years ago, there was controversy and panic among political and non-political actors when it became public that Ghana was set to carry out clinical studies into a vaccine for the Ebola virus disease.
Mrs. Privor-Dumm, said all clinical studies into a vaccine would follow strict protocols and the country’s local Institutional Review Board (IRB) would need to approve the study before it moves forward to ensure all appropriate processes are followed.
According to Mrs. Privor-Dumm, currently there are over 70 vaccine candidates at the early stages of development with six having entered phase I or II and these are coming from Chinese, American and United Kingdom institutions.
Some of the developers in China and America that have reached phase I or II are the CanSino Biological Inc/Beijing Institute of Biotechnology, Inovio Pharmaceuticals, Beijing Institute of Biological Products/Wuhan Institute of Biological Product, Sinovac and Moderna/NIAID. Recently, University of Oxford reported entering phase I/II.
Throwing more light on how vaccines work, Mrs. Privor-Dumm added that few vaccines progress past the pre-clinical and early clinical phase, so it is still early to say which vaccine would emerge among the variety undergoing clinical trials.
The policy advisor noted that “we are hopeful, but there is no guarantee that any of these will succeed as there are many unknowns.”
She explained that the question on which of vaccine is the most promising would also depend on safety and effectiveness in certain populations such as the aged.
“Additionally, you would want to understand how the vaccine could be delivered and work in populations living under different conditions, such as crowding, lower access to healthcare, varying rates of underlying disease, undernutrition and more.”
In response to how long it would take for the world to have a vaccine which can be licensed for use globally, she said some have claimed they’d have a vaccine ready for emergency use by the fall, but most experts believe “that it will be 12-18 months before a vaccine is licensed for routine use.”
“Even then, that is a hugely accelerated timeline compared to other vaccines. Plus, licensure is only half the battle – there needs to be a plan for deployment and that process can be quite lengthy,” she noted.
The recent shortages, scrambling, hoarding and diversion of medical supplies across nations caused by the coronavirus pandemic are very useful lessons that every country has to take note of.
Overnight, every country became more concerned for its citizens in looking for items such as facemasks, sanitizers and ventilators including other vital medical supplies to halt the spread of the virus among its populations and their frontline staff, especially because of the huge death toll which was occurring in the developed countries.
Ghana and other countries may therefore have to brace themselves for a long haul before they can benefit from an efficacious vaccine if one is birthed before the end of this year.
Perhaps to respond to this fear that some countries may be left out of any potent weapon against the pandemic, there are reports that at a recent meeting a few days ago, the 193 members of the UN General Assembly adopted by consensus a resolution calling for equitable, efficient and timely access to any future vaccines developed to fight the coronavirus.
The UN’s position may be the best. However, should there be a first-ever potent coronavirus vaccine, would governments in the developed economies be ready to provide funds to ensure that such a vaccine is accessed by all countries on fair terms?
Would bodies such as the WHO or the GAVI Alliance be at the forefront to fund the “equitable” and “timely access” and distribution of vaccines as prescribed by the UN so that developing countries across Africa can have their share?
At least, what is important for now is that various funders and sponsors are working on a COVID-19 vaccine with the Coalition for Epidemic Preparedness and Innovation funding a number of vaccine efforts including various governments as well.
For instance, On April 21, the BBC carried a report that the UK government was throwing everything at developing a coronavirus vaccine.
It quoted Health Secretary, Matt Hancock who said this at the daily Downing Street briefing and added that human trials for a vaccine, developed by the University of Oxford, would begin in a few days.
Mr Hancock was reported as saying that “the best way to defeat the coronavirus” was through a vaccine.
The process was “trial and error”, he said, but the UK was at the “front of the global effort” and had invested more money than any other country.
He said two leading vaccine developments at UK universities – Imperial College London and the University of Oxford – would receive a total of £42.5m to support their clinical trials.
“Both of these promising projects are making rapid progress and I’ve told the scientists leading them we will do everything in our power to support,” he had added.
For countries such as Ghana and other developing countries, they may need to do a quick evaluation of the situation and decide, if, where, when and how they would respond to a possible clinical studies on COVID-19 vaccines, should the opportunity arise as was the case during the Ebola crises.
With the unfolding and often fluid events surrounding the COVID 19 pandemic and the urgency to find a potent vaccine to deal with the rising mortality and morbidity statistics, including the socio-economic burden of the pandemic on every country in the world, nations such as Ghana cannot remain aloof but seek for the right opportunity to join in the global effort to find a permanent solution to the disease.
During the Ebola crises, when neighbours in the West Africa sub-region were reeling under the burden of the Ebola virus disease, Ghana miraculously escaped and remained free of Ebola.
Back then, it was quite easy to kick against Ebola vaccine trials in Ghana. Perhaps, now on hindsight, Ghana should have allowed the clinical studies on the Ebola vaccine when around 2014-2015, the Ebola outbreak in the sub-region was a global public health emergency.
During this crisis just like today, there was a flurry of activities by funders and sponsors globally to conduct some trials for a vaccine with Ghana being one of the countries chosen to help in this effort but this decision met with stiff opposition and a section of the media landscape became awash with reports, which caused fear and panic.
The planned phase I and II Ebola vaccine trials set to take place at two Ghanaian towns, Hohoe and Kintampo, were abruptly put on hold with fears that Ebola would be imported into the country if the studies are carried out and that these tests could come along with side effects among the study participants and many more arguments became the talk of town for several days.
Had Ghana undertaken these Ebola vaccine studies, perhaps, it may have positioned the country strategically to serve as a partner for a future phase III clinical studies for a COVID-19 vaccine and the country could have been a direct beneficiary of any positive outcome if studies prove successful.
There is still room for hope as fortunately Ghana, unlike some countries in Africa, has been able to participate in some international drug and vaccine studies involving phases II and III clinical trials into the world’s first malaria vaccine, RTS,S. The country also took part in a phase IV post-market clinical trials of some antimalarial drugs under an INESS project.
As a result of these studies, the country’s research institutions and scientists have some wealth of experience to build on any drug or vaccine trials.
However, the issue of vaccines and immunizations in general have always sparked lots of controversies not only in Ghana but elsewhere across Africa and Asia.
For instance, reports about whole communities in some countries derailing official immunization programmes among children, which has led to instances of a re-emergence of polio cases is not uncommon.
Even during the clinical trials into the RTS,S malaria vaccine in Ghana, some parents were discouraged from giving out their children as study participants based on issues such as the drawing of blood for the study.
All these became a source of worry, however, the RTS,S has programme survived and is at a new stage under a pilot.
The Global Push
Since the outbreak of the COVID-19, every country in world has been affected one way or the other due to the disruptive impact of the pandemic on lives and businesses.
This has given rise to the push to find a magic bullet, in the form of a vaccine. Global health actors, private sector partners and other stakeholders a few days ago, launched a landmark collaboration to accelerate the development, production and equitable global access to new COVID-19 essential health technologies.
A few day ago, a new collaboration was co-hosted by the WHO Director-General Dr Tedros Adhanom Ghebreyesus, President Emmanuel Macron of France, Ursula von der Leyen, President of the European Commission, and the Bill and Melinda Gates Foundation.
The virtual event included senior United Nations, government and public health and industry leaders from around the world such as the UN Secretary General, the AU Commission Chairperson, the G20 President, heads of state of South Africa, Germany, Vietnam, Costa Rica, Italy, Rwanda, Norway, Spain, Malaysia and the UK (represented by the First Secretary of State).
Other key and industry players were health leaders from the Coalition for Epidemic Preparedness Innovations, GAVI, the Global Fund, UNITAID, the Wellcome Trust, the International Red Cross and Red Crescent Movement (IFRC), the International Federation of Pharmaceutical Manufacturers (IFPMA) and the Developing Countries Vaccine Manufacturers’ Network (DCVMN).
They were joined by two Special Envoys: Ngozi Okonjo-Iweala, Gavi Board Chair and Sir Andrew Witty, former CEO of GlaxoSmithKline.
All these stakeholders pledged to work towards equitable global access based on an unprecedented level of partnership.
They agreed to create a strong unified voice, to build on past experience and to be accountable to the world, to communities and to one another.
The WHO Director-General speaking at the launch of the Access to COVID-19 Tools Accelerator, noted that the pandemic is an “unprecedented global crisis that has been met with an unprecedented global response.”
He explained that research and development have played a central role, adding that since January, the WHO has been working with thousands of researchers all over the world to accelerate and track vaccine development – from developing animal models to clinical trial designs, and everything in between.
Dr. Ghebreyesus said past experience has taught that even when tools are available, they have been not been equally available to all, adding: “We cannot allow that to happen.”
He told his audience, the WHO is proud to be uniting with many partners to launch the Access to COVID-19 Tools Accelerator, or the ACT Accelerator and said this “is a landmark collaboration to accelerate the development, production and equitable distribution of vaccines, diagnostics, and therapeutics for COVID-19.”
“Our shared commitment is to ensure all people have access to all the tools to defeat COVID-19.”
He touched on the importance of evaluating as many vaccines “as possible as we cannot predict how many will turn out to be viable.”
“To increase the chances of success (given the high level of attrition during vaccine development), we must test all candidate vaccines until they fail. WHO is working to ensure that all of them have the chance of being tested at the initial stage of development.”
There were additional statements highlighting the WHO’s actions, which said that they were “harnessing a broad global coalition to develop and evaluate candidate vaccines as quickly and safely as possible by convening and coordinating multiple public and private partners and using the best scientific and public health evidence and ethical principles.”
“Mapping candidate vaccines and their progress across the world and fostering regular open dialogue between researchers and vaccine developers to expedite the exchange of scientific results, debate concerns and propose rapid and robust methods for vaccine evaluation.”
All these actions and statements have defined the global push at seeking for a safe and efficacious vaccine and therefore African governments should actively join in all the coordinated actions and seize any opportunity to work together with others across the globe.
Right from the beginning of the pandemic, everything has pointed to the fact that it is only a united global response and contributions from both the developed and developing countries that would bolster the fight against COVID-19 and stop its spread all over the globe.
This is because the pattern and spread of the virus has shown that the inability of any single person, community and country to curb the pandemic has serious implication for everybody’s safety.
The simple message from all quarters is that it a global action against the pandemic that would work and not an individual affair.
A recent news report carried by Bloomberg said with experimental vaccines progressing, governments and health groups are turning to the challenge of producing enough doses to meet global demand and ensuring that shots are distributed equitably.
It quoted the chief executive of the Coalition for Epidemic Preparedness Innovations and said the coalition wants to set up manufacturing in every region of the world and has been talking with other groups including GAVI, the Vaccine Alliance, which helps developing countries finance and distribute vaccines.
“Given the economic disruption that is caused by the pandemic and the global interconnectedness of the economy, if we don’t address the pandemic everywhere, we will still be at risk,” the report quoted Richard Hatchett, the head of the Coalition for Epidemic Preparedness Innovations.
He had added that developers “are mindful of examples in the past where rapid vaccine development “unfortunately led to bad outcomes.”
“We take it with the utmost seriousness. We cannot cut corners. It’s absolutely critical that we ensure safety and efficacy,” he added.
The report added that the chief executive of the coalition stated that the coalition has secured commitments for about half of the $2 billion it estimates would be needed to develop the vaccines, and it may invest in 15 or more programmes and is partnering with companies including Moderna and Inovio Pharmaceuticals Inc., along with institutions such as Oxford and the University of Queensland in Australia.
Indeed the global action is on course and under the direction of the WHO. The global body has worked towards coordinated action since the outbreak of the pandemic a few months ago.
This is based on the narration from the beginning as told by the WHO indicating that 31st December 2019, the WHO was informed of a cluster of cases of pneumonia of unknown cause detected in Wuhan City, Hubei Province of China.
The Chinese authorities identified the SARS-CoV-2 as the causative virus on 7th January 2020, and the disease was named coronavirus disease 2019 (COVID-19) by the WHO on 11th February, 2020.
On 30 January 2020, following the recommendations of the Emergency Committee, the WHO Director-General declared that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC).
World scientists on COVID-19 met at the World Health Organization’s Geneva headquarters from 11 to 12 February 2020 to assess the current level of knowledge about the new virus, agree on critical research questions that need to be answered urgently, and ways to work together to accelerate and fund priority research that can contribute to curtail this outbreak and prepare for future outbreaks.
As part of WHO’s response to the outbreak, a Research and Development (R&D) Blueprint was activated to accelerate the development of diagnostics, vaccines and therapeutics for the novel coronavirus.
Under the leadership of WHO, a group of experts such as scientists, physicians, funders and manufacturers from different backgrounds started working towards the development of vaccines against COVID-19.
It was acknowledged that the development of vaccines for general use takes time, yet a vaccine may ultimately be crucial in controlling the global coronavirus pandemic.
The group saw their coming together as part of efforts to help reduce inefficiencies and duplication of effort as they work tenaciously to increase the likelihood that one or more safe and effective vaccines will soon be made available and pledged to speed up the development of a vaccine as rapidly as possible.
This is why African countries such as Ghana should make every effort to take advantage of any opportunity to join in the global search for a lethal vaccine against the COVID 19 pandemic.
By Eunice Menka
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