Testing Monkeypox Vaccines in Kenya? Probably Not!
On 28th July 2022, Tonix Pharmaceuticals announced that it would be collaborating with the Kenya Medical Research Institute (KEMRI) with the goal of planning, and seeking regulatory approval for conducting a phase 1 clinical study in Kenya to develop TNX-801, as a vaccine against monkeypox and smallpox. The study is anticipated to start in the first half of 2023. This is a decision that has raised concerns among Kenyans.
The vaccine is likely being tested in Kenya owing to reports that the Central African strain is reportedly more fatal than the West African strain which has spread outside of Africa and has a low fatality rate. Additionally, the testing of the monkeypox vaccine in Kenya also allows for Kenya to be prepared with a vaccine that offers protection. It can be widely deployed without the need for sterile injections or ultra-cold shipping and storage stated Professor Matilu Mwau, Ph.D. of KEMRI.
Are they testing on people or animals (monkeys)? This concern was evident on Twitter where one individual stated that they were concerned that the study would take the same direction as Ebola vaccine testing in the 1990s. the individual claimed that the testing of Ebola vaccines in Africa resulted in the outbreak of Ebola on the continent. I was however unable to substantiate this claim.
Concerns also lie in that the phase 1 clinical study is the first to involve people. This raises concerns that Kenya is being used as a testing ground for pharmaceuticals turning people into guinea pigs. There have been few instances where drug testing has gone wrong with the most memorable I have heard of being the one below. However, with advancements in ethics when involving human subjects, all we can hope for is patients are informed of what to expect.
Patients involved in phase one trials often have concerns about adverse events such as vomiting, hematuria, dizziness, fever, and personality changes. Doctors on the other, hand tend to be concerned about blurred vision, confusion, and eye disorders. In the past, there have been concerns that few clinical trials are held in Africa. Africa has a rich-genetic diversity which is one of the reasons which have been used to justify clinical trials in Africa.
Clinical trials are often done in Africa when there is a burden of conditions and diseases on the continent. This is not the case in this instance as Kenya currently has no reported case of monkeypox. Nevertheless, there are over 300 reported cases of monkeypox on the African continent.
The opposition to the trial being held in Kenya also comes from the lingering mistrust of Western Pharmaceutical companies, owing to a history of medical exploitation in Africa. During the colonial period in Africa, the establishment of medical services went hand in hand with the launching of research programs on various subjects thus turning Africa into an arena for experimentation. In one instance, Africa was referred to as having an abundance of “clinical material”. Furthermore, during this period, there were no agreed-upon ethical standards for research with human subjects. Furthermore, the methods were not clear in both the administration of the clinical trials and the treatment of infectious diseases. This mistrust also means that there are fears that the clinical trial could introduce the monkeypox virus in the country. Kenyans are also concerned that despite being involved in the clinical trials should the vaccine pan out, they will be the last to have access to it. This was already evident in the case of the COVID-19 pandemic where African countries were left out as Western countries scrambled for vaccines for their population.
Also, Kenyans are yet to forget the scandal that involved KEMRI that resulted in the minting of COVID millionaires, with billions being unaccounted for. Lest we forget, KEMRI is the organization Tonix pharmaceuticals will be collaborating with.
In conclusion, there has been a resounding message among healthcare professionals that Africa should be involved to a greater extent in clinical trials. However, they have to deal with the challenge of allaying the fears of the population and ensuring that there is accountability and ethics are upheld. Allaying these fears will be a major challenge in Kenya, considering that in the developed world a segment of the population believes that monkeypox is a “gay disease”.