KEMRI to Investigate the Oxford Vaccine in Kenya for Phase 3 Trial While Low Death Rate Perplexes the Experts

Sep 22, 2020 | Africa, COVID-19, Kenya, News, Oxford, Popular Posts, Vaccine

KEMRI to Investigate the Oxford Vaccine in Kenya for Phase 3 Trial While Low Death Rate Perplexes the Experts

COVID-19 clinical trials are coming to the East African nation of Kenya, led by Kenya Medical Research Institute (KEMRI), an important governmental research agency. The national research group formed a partnership with University of Oxford to conduct the trial investigating the COVID-19 vaccine candidate ChAdOx1 nCoV-19. Recently, the clinical trials involving ChAdOx1 nCoV-19 were paused due to an adverse event reported in the United Kingdom. However, the trial has again commenced in the UK, India and elsewhere; however, the study is still temporarily paused in America. In Kenya, KEMRI appears close to initiating a Phase 3 clinical trial to investigate the safety and efficacy of ChAdOx1 nCoV-19 in this growing East African nation. An impressive Principal Investigator, Professor George Warimwe, leads the important effort. TrialSite offers a brief overview of KEMRI, the study, the enigma associated with strikingly low COVID-19 infection and death rates in East Africa and recent events in Kenya.

COVID-19 in Kenya: Low Severity & Death Rates

COVID-19 hasn’t struck Africa nearly as hard as Europe or the Americas. With nearly 54 million people residing in Kenya, it’s the seventh most populous country in the continent. Thus far, the entire country reports 37,079 cases with 650 deaths. To put into perspective, Italy, with a population of 60 million, reports 299,506 cases with 35,724 deaths. Below TrialSite reveals other East African nations have strikingly similar low infection and death rates associated with COVID-19.

Research conducted in Kenya found that about 1 in 20 adults in the East African nation were infected with SARS-CoV-2, the virus behind COVID-19, or about 5% of the population. Yet its death rate is far lower than comparable countries in size, infection rate, and similar levels of antibodies.

But why are these rates so low? No one is certain. The science writer for Quartz, Olivia Goldhill, covered this subject offering different perspectives, such as one from Duncan Nyukuri, an infectious disease doctor at Kenyatta National Hospital in Nairobi. “Coronavirus is a new disease and there’s a lot of unknown. We are still speculating,” Nyukuri commented for Ms. Goldhill’s piece in Quartz. He suspects the youthful demographic there could be a contributing factor. After all, over 50 percent of the country’s population are under 20 and only 4 percent are over 60, according to a report on the subject from the United Nations University World Institute for Development Economics Research.

Ms. Goldhill offers other possibilities that could possibly influence the enigma. First, some believe that because many Kenyans are taking other medications (Ivermectin?) or vaccines, that this could contribute to the lessening of COVID-19 severity nationwide. While Anne Barasa, an immunologist at the University of Nairobi and Kenyatta National Hospital, suggests that its possible antivirals associated with HIV care management could be a factor. About 2 percent of the population take such medications, reports Ms. Goldhill. Dr. Barasa interestingly observes that a majority of those Kenyans testing positive for COVID-19 are in fact asymptomatic.

Barasa also brought up the topic of BCG [Bacille Calmette-Guerin tuberculosis vaccine] as some researchers and physicians have speculated that this vaccine may inhibit or stop COVID-19. In fact, there are at least 21 clinical trials around the world exploring this very question. However, Dr. Barasa noted this same vaccine is common in India and that country has experienced greater severity in the infections. Could genetics be a factor?

It is noteworthy that the urban centers of Kenya have experienced most COVID-19 cases, reports the Quartz article. Yet Kenya is still only 30 percent urbanized—an overwhelming majority live in rural areas and it turns out a majority of the elderly reside with this majority out in the countryside or in small to mid-sized villages.

The Enigma of East Africa & COVID-19

As it turns out, other countries in East Africa have incredibly low rates of COVID-19 infection and corresponding death rates as well. For example, with 43 million inhabitants, authorities in Uganda report 6,468 total COVID cases and 63 deaths. With 56 million people, Tanzania reports only 509 cases and 21 deaths, which are strikingly low numbers.  Somalia, with 15.8 million, reports 3,465 cases with 98 deaths. Interestingly, Ethiopia, with 109 million, is somewhat of an exception as it has a reported 69,709 cases and 1,108 deaths, but these figures are still incredibly low compared to many nations in Europe, the United States, and locations in South America, for example.

The Oxford Vaccine Coming to Kenya

Developed by University of Oxford, ChAdOx1 nCoV-19 is considered one of the top COVID-19 vaccine candidates worldwide by the World Health Organization, the U.S. government and others. By April 30, AstraZeneca and University of Oxford entered into an agreement to co-develop the recombinant adenovirus targeting COVID-19. AstraZeneca would not take on the hugely expensive effort of bankrolling Phase 3 clinical trials, manufacturing investigational vaccine product at risk and commercialization.

Since then, the Anglo/Swedish pharmaceutical giant has secured a number of high profile deals with the government of the United States ($1+ billion), the United Kingdom, European Union, CEPI/GAVI ($750m), Serum Institute of India, Brazil, Russia and more.

Momentum for AstraZeneca and AZD1222 accelerated in the United States until recently. Again called ChAdOx1 nCoV-19 by Oxford, but known as AZD1222 in AstraZeneca license territories, the vaccine candidate has been at the top of news as of late with a material clinical trial delay. 

In the UK where AstraZeneca is leading the COVID-19 vaccine trials, a safety event on September 9 involving one of the study subjects triggered a review by an independent safety monitoring committee. A routine type of action, the trial has restarted in the UK and India but not the United States as of yet. 

By July 1, 8,000+ participants had already been dosed with the Oxford vaccine.

Leading Clinical Trials in  Kenya

Actually established via the Science and Technology Act of 1979, (since then amended to the Science Technology and Innovation Act 2013) Kenya Medical Research Institute, known as KEMRI, has grown from humble origins to a regional and perhaps even continent-level leader in human health research. According to the organization’s website, they are positioned as one of the leading “Centers of Excellence” in health research in both Africa as well as worldwide. 

With a mission to “improve human health and quality of life through research, capacity building, innovation and service delivery,” the research arm of the Kenyan government serves a number of functions from health advisory and counsel to national disease surveillance and rapid disease response for major disease outbreaks, such as Cholera, Chikungunya Virus, Ebola, etc. Running several important programs of national, regional and even global impact, they even run a research post-graduate school and have done so since 1992. The organization is led by Director-General Prof Kombe Yeri

The COVID-19 Vaccine Trial Preparation

According to recent press, including AllAfrica, Maureen Ongala reports that up to forty Kenyans will participate in this KEMRI led clinical trial involving the University of Oxford vaccine known as ChAdOx1 nCoV-19.

Director-General Prof Kombe Yeri shares that the research center still must secure approvals from local ethics to final regulatory greenlight. The Deputy-General informed National Assembly Health committee members at a recent meeting, “We were conducting several preparations ahead of the trials. First, it was important for us to get all valid licenses from relevant authorities. The KEMRI team must also ensure that the vaccine is of the required standards and is not harmful to humans.”

KEMRI has secured Ethics Committee approval via the KEMRI Scientific Ethics Review Committee, as well as thumbs up from the Pharmacy and Poisons Board and from the National Commission for Science, Technology and Innovation.

However, Ms. Ongala reports KEMRI still awaits final approvals from local authorities in Kenya, ranging from Kenyan provinces to select authorities overseeing study sites.

Clinical trials by law require public participation in Kenya. Hence, KEMRI must not only keep stakeholders updated but also must hold at some point a public participation concerning the trial. For more on study start up and clinical trials rules in Kenya, see ClinRegs, a great free online tool made possible now by the National Institute of Allergy & Infectious Diseases (NIAID)

The Study Lead

The clinical trial will be led by Professor George Warimwe, who conveyed the importance of determining whether this vaccine can work well in the Kenyan population. Prof. Warimwe emphasized the importance of clinical research to the health and well-being of the people in Kenya and worldwide. He compared the current effort to the Ebola virus, emphasizing a comparable approach was employed to control that virus and ultimately the epidemic in West Africa. Prof. Warimwe carries impressive credentials. Not only is he Principal Investigator for the KEMRI/Wellcome Trust but he also is employed by University of Oxford, Nuffield Department of Medicine as an associate professor

Growth & Uneven Development

Kenya has been on an economic development growth trajectory. Although the country ranks sixth continent wide for size of gross domestic product, its per capita GDP ranks 17.th

A recent World Bank report, Policy Options to Advance the Big 4: Unleashing Kenya’s Private Sector to Drive Inclusive Growth and Accelerate Poverty Reduction,” suggests that economic indicators are superior in Kenya to most of Sub-Saharan African (SSA) countries; however, the East African nation lags behind other lower middle-income countries. About 40 percent of the country lives below the poverty line.

According to one report, “…[T]he country has made remarkable progress in improving health indicators over recent years.”

Noble Aspirations but Severe Shortage of Medical Staff

As the government strives for universal health coverage, other accounts depict a health system in deep trouble; one that finds 40 percent of graduating doctors leaving the country for work elsewhere due to lack of opportunity. On the World Health Organization (WHO) list of countries with critical shortages of doctors, corruption associated with the health ministry materialized in a public scandal

Crony Capitalism Impacts Research Attraction

Concerns about money surface in regards to research endeavors. AllAfrica reported that Sabina Chege, a former actress turned politician—now serving as Health committee chairperson—fretted that the government should allocate greater funds to KEMRI. Apparently, her concern centers on the research agency’s dependence or “over-reliance” on “donors.”

Kenyans are concerned about health research funds, given what appears to be a recent scandal involving the Kenya Medical Supplies Authority (KEMSA). Consequently, with allegations of graft top of mind, Ms. Chege commented, “Kenyans are waiting for the report on alleged misappropriation of funds at KEMSA (Kenya Medical Supplies Authority). This matter involves a lot of people before the public can know if the COVID-19 funds were utilized well or not.” Well it turns out, Ms. Chege has good reason to be concerned. On Sept 9, it was reported that detectives from Kenya’s Ethics and Anti-Corruption Commission (EACC) raided KEMSA offices searching for evidence of malfeasance. 

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