Maame Kessewah Addo writes: Vaccine trials in Africa – What the general public must know

Amidst current times of this COVID-19 pandemic, there is a lot of false news and false claims being circulated on the internet. One of the messages that caught my attention and is of interest to me is this post making rounds on social media about vaccines for COVID-19 to be tested in Africa instead of the developed countries. A lot of people are generally advising African leaders against this action. Their argument is simple, the death toll from the virus among developed countries in the western world and Asia is much higher than that in Africa thus vaccine trials must be conducted in these countries and continents rather than Africa. And this argument actually holds water.

In a way, it makes a lot of sense, why conduct a vaccine trial in Africa where there is a lower death rate instead of the other continents where they are recording the highest numbers of cases and deaths from the pandemic?  But the thing is no one can just enter any country to try any vaccine or drug, especially a country like Ghana where working systems have been put in place.

Let’s begin by trying to understand what a vaccine is. According to the Centers for Disease Control and Prevention (CDC), a vaccine is a product which when administered to an individual, stimulates their immune system to develop immunity against a specific disease. Immunity basically refers to protection from an infectious disease, so if one is immune to a disease, that individual can be exposed to the pathogen that causes the disease but would not come down with the infection. Typically, a vaccine contains a substance that resembles a disease-causing organism. Mostly, it could either be made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins which trigger the immune response in the healthy individual.

Several trials have been conducted in the developed world alone and Africa has benefited from them. Some trials can be conducted in more than one site; some countries can be conducting some components of them whilst other components of the same trial are being done in other countries. And this can be done in both developed and developing countries. Other times, people react differently to vaccines due to their race or genotype etc. Thus some trials are conducted in specific populations.

Before any vaccine or medication is administered to humans in a clinical trial, they would have gone through a series of tests (Pre-Clinical Studies). At this stage, the product is tested on animals, and in test tubes, etc. in a lab to obtain more information about the product, how it works and interacts with the body, how safe it is, whether it works or not etc. Based on results from these studies, scientists can then decide to move the studies to humans to examine how it will work on humans in clinical trials. There are several stages of clinical trials a vaccine or drug goes through before it gets to the general population. Ranging from phase one to phase four trials. With phase one involving few tens of healthy individuals, through to phase four which involves the general public or thousands–at this phase the drug or vaccine would have been proven to be effective and safe. At each phase, the safety of participants is of paramount concern and is ensured by strict rules and check measures. Regular tests and monitoring are done throughout the period of the trial. In the case of an adverse event in the conduct of a trial,well-trained physicians are available to handle the situation.

In the past, some trials were conducted unethically; some were done without seeking the consent of participants, others were done to cause harm to vulnerable groups. Talk about the Tuskegee Syphilis Study in 1932-1972 which Africans were deceived they were being given treatment for syphilis when they were not and a lot of lives were lost despite the existence of treatment for the condition, or the Guatemala Syphilis study in which doctors infected soldiers, prostitutes and other vulnerable groups with syphilis to observe the progression of disease, and many other trials conducted unethically. These incidents in which the human subjects’ safety was not prioritized and rights were not protected birthed codes that spell out clearly how clinical trials should be conducted to protect these study participant and regulatory bodies to critically check critically what a research proposal contains, history of the drug or vaccine, harm, risks etc. Before approving of the study to be conducted in any country.

The main responsibility of all is to ensure the safety of every trial participant in a clinical trial. There are a several regulatory agencies in place to ensure the rights and safety of anyone who partakes in a clinical trial are upheld and not infringed upon. These institutions are comprised of experts from different background who are well-educated in the country. All their activities are guided by principles and international guidelines and regulations that guide the conducts of all trials in humans irrespective of location.

Their mandate is to ensure the safety of participants and see that researchers adhere to these regulations governing the conduct of clinical trials. In Ghana, institutions like the Ghana Health Service Ethics Review Committee, Food and Drugs Authority, Ghana Standards Authority, Ministry of Health among others are charged with this mandate to regulate trials and ensure that all proposals for clinical trials are scientifically and ethically sound before they are approved. Highly prestigious research centres such as the Navrongo Health Research Center, Kintampo Health Research Center and the Agogo Health Research Center among others have certified Ghanaian Scientists and researchers who conduct several studies. Before the commencement of any trial,these regulatory agencies critically scrutinize the research proposal to make sure that the product is safe, has medical benefits and will not harm study participants. During the conduct of the study, these agencies follow closely the activities of the researcher and demand complete transparency on all activities of the research center.

All adverse and severe adverse events must immediately be reported to the FDA and all the other regulatory agencies aforelisted and they have the mandate to terminate the trial if need be. I must comment that the FDA of Ghana is one of the most respected worldwide due to how they execute their tasks but the letter and efficiently.

They ensure that the trial is not harmful, will benefit participants, already existing treatment is not withheld from participant and most importantly, the rights of participants are protected.

Researchers have the responsibility to seek voluntary informed consent from anybody willing to partake in a study. This means that the researcher must explain the details of the trial to the participant and answer any question the participant has concerning the trial after which if the probable participant is satisfied, he or she will give consent to be apart of the study. And as the study proceeds if an individual does not want to continue with the study, he or she can withdraw from the study. No researcher has the mandate to coerce anybody to receive a vaccine and in Ghana, the FDA, Ministry of Health, Ghana Health Service, Ethical Committees of the various research centres ensure that consent is properly sought. Therefore, let us all be rest assured that our team of competent and well-meaning experts will use their right judgement and ensure that only appropriate products are given a pass to be tried in our noble country. The hard work of these regulatory agencies have been a “gate” that have controlled what enters the country and what does not.

COVID-19 is a disaster and we are all being affected by it. Just like any other vaccine trials like the Rotavirus vaccine trial, Malaria Vaccine trial, Yellow fever vaccine trial, etc.

Some of the studies will be conducted on the African continent among other continents. And as usual we are counting on our able regulatory bodies and scientists to protect us. In these trying times, our scientific community are staying up day and night to come up with something to save the world. And we pray that God will help them come up with something quickly to curb this menace. Let us not mar their efforts with misguided rumors.

If we can do anything, let us pray and support them and hope God leads them to the answers. Until then, let’s stay safe, wash our hands frequently with soap under running water and follow all other directives giving to us by our competent healthcare workers. In the absence of soap and running water use hand sanitizers and stay home as we have been asked to.

May God bless and keep us all.
Ms. Maame Kessewah Addo (RD.LD, MScClinicalTrials)

REFERENCES
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Retrieved 2020-04-16
CIOMS Guideline20: Strengthening capacity for ethical and scientific review and
biomedical research.
Julian D. The data monitoring experience in the Carvedilol Post-Infarct Survival Control
in Left Ventricular Dysfunction Study: hazards of changing primary outcomes.In:
DeMetsDL, FurbergCD, Friedman LM(eds) Data Monitoring in Clinical Trials: A Case
Studies Approach.NewYork:Springer,2006

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