KENYA — The KEMRI Wellcome Trust Research Programme, a world-renowned health research centre situated in Kilifi, Kenya, has conducted clinical studies to demonstrate the efficiency of the newly developed R21/Matrix-M vaccine, which aids the body’s battle against the malaria parasite.
This vaccine was developed at the University of Oxford Jenner Institute in conjunction with the Serum Institute of India and tested in Kenya with the Kemri Wellcome Trust.
The vaccine targets the plasmodium ‘sporozoite,’ the malaria parasite’s earliest form of entry into the human body.
Malaria is one of Africa’s leading causes of mortality, with an estimated 10,000 deaths in Kenya each year.
Flu symptoms emerge after being bitten by a mosquito and becoming infected with the malaria parasite. This is followed by sudden chills, intense sweating, a high fever, and headaches.
If left untreated, the parasite may eventually kill red blood cells, causing organ failure such as renal failure. Death comes swiftly after.
According to Ministry of Health projections, over 10,000 Kenyans, predominantly small infants, will have perished as a result of this cycle by 2023.
This clinical trial enrolled 600 Kenyan children in phase three trials for the R21 vaccine to demonstrate its efficacy in treating the malaria parasite right before flu symptoms manifested.
The clinical study results showed that the vaccine had a high efficacy level of roughly 75%, compared to 30% for RTSS, the only other malaria vaccine available.
In places with extremely seasonal malaria transmission, such as when malaria transmission is mostly limited to four or five months per year, the vaccine reduced symptomatic malaria cases by 75% after a three-dose series.
The Phase III trial results demonstrated great efficacy when the vaccine was administered right before the peak transmission season.
In a Lancet report on the Phase III trial, the researchers observed that the vaccine was well tolerated, with injection site pain and fever being the most common local and systemic side effects.
Based on pre-clinical and clinical trial data, the vaccine demonstrated good safety and high efficacy in four countries with both seasonal and perennial malaria transmission.
Burkina Faso, Kenya, Mali, and Tanzania were the four countries that participated in the trial, with a total of 4,800 children recruited. On April 13, 2023, Ghana became the first country to approve its rollout.
Following the announcement of the clinical trial findings, WHO chief Dr Tedros Adhanom, on his X (formerly Twitter) account, noted that currently there are two prequalified malaria vaccines, and children in at-risk settings, predominantly in Africa, can receive even more protection through safe and effective vaccines.
Adar Poonawalla, CEO of the Serum Institute of India, stated that the firm is prepared to create up to 100 million doses in the first year, which will be expanded up to 200 million doses (per year) during the next two years.
Prof Sir Adrian Hill, head of The Jenner Institute, stated in a statement that the R21/Matrix-M development took 30 years of collaborative research and development due to the complex composition of malaria parasites with a shape-shifting pathogen.
According to him, the parasite has learned how to evade the immune system, which has made the development of an effective vaccine a formidable task
Dr. Seth Berkley, CEO of Gavi, remarked that while it took the globe more than 50 years to produce a malaria vaccine, this year’s introduction served simply as a reminder of what has to be done to make malaria vaccines available to every child in need.
He went on to highlight how African countries have been waiting for a vaccine against one of their most lethal killers, noting that if global health, countries, suppliers, and civil society work together, they can help prevent tens of thousands of child deaths each year, in addition to other malaria control interventions.
According to Gavi, a vaccine funder located in Geneva, both vaccines will not eliminate Malaria, but when combined with other preventive methods such as bed nets and seasonal chemoprevention, they will help prevent many deaths and infections.
Gavi explained in a recent report how the world could increase supply to meet demand by increasing the number of manufacturers and enabling scale-up through predictable demand.
With an estimated 40-60 million doses needed by 2026 alone, rising to 80-100 million doses needed annually by 2030, Gavi said governments, vaccine makers, and health authorities must take action to reach this objective.
The Gavi plan calls for countries and partners to collaborate in critical areas such as demand forecasting, increasing the number of suppliers, and knowledge transfer to ensure the widest rollout of malaria vaccines in endemic countries.
RTSS is already widely available in Western Kenya, and four doses of RTS,S vaccine reduce clinical malaria cases by 39% and severe malaria cases by 30% when compared to R21.
After the World Health Organization granted it prequalification status late last month, R21 is now likely to be more readily available in Kenya by 2024.
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