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On 2 October 2023, when India celebrated both Gandhi and Lal Bahadur Shastri Jayanti, there was one more reason to celebrate this year. On that day, the World Health Organization (WHO) approved a new vaccine, R21/Matrix-M, to prevent malaria in children. And this vaccine is produced and scaled up by the Indian vaccine manufacturer Serum Institute of India (SII).
In April 2023, almost coinciding with World Malaria Day, the West African nation Ghana approved the malaria vaccine R21, even before it was approved by the WHO. The vaccine R21 is developed at the University of Oxford and produced by the world’s largest vaccine manufacturer, Serum Institute of India. The Ghana Food and Drugs Authority approved the vaccine for children between five and thirty-six months, the age group at the highest risk of death from malaria. Following Ghana, two more African nations, Nigeria and Burkina Faso, also approved it before the formal approval from the WHO.
Clinical trials for this specific vaccine have been conducted in the UK, Thailand, and various African nations. This includes a Phase III experiment with 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania. Earlier, the 2021 Phase IIb trial data from Burkina Faso demonstrated 77% effectiveness and a comforting safety profile after administering three primary doses and a one-year booster. The WHO approved it for usage as the vaccination achieved the 75% effectiveness threshold set by the WHO during the first two phases.
Before the R21/Matrix-M vaccine, GlaxoSmithKline (GSK) plc developed and manufactured the first malaria vaccine, RTS, S/AS01. Since 2019, pilot programmes introducing the RTS, S vaccine have resulted in at least one dose for 1.7 million children in three countries- Ghana, Kenya and Malawi.
Twelve nations in various parts of Africa, including Ghana, Kenya, and Malawi, have already been in agreement and are anticipated to receive 18 million doses of the RTS, S malaria vaccine over the following two years. The first vaccine doses of the RTS, S should arrive in these countries in the final quarter of 2023 and begin to be administered by early 2024. In response to the growing demand, Bharat Biotech is likely to start producing RTS, S. On the other hand, the R21 vaccine will be available for use only after mid-2024.
However, there is no direct competition between R21 and RTS, S, and they have not been put to a side-by-side trial. Further, there is no evidence so far that one vaccine works more effectively than the other. Both vaccines have a similar 75% effectiveness rate when given under the same circumstances. Therefore, any country would be free to select one of the vaccines based on its programmatic factors, availability, and affordability.
In essence, the R21/Matrix-M malaria vaccine is a low-dose vaccination that can be produced in large quantities at a reasonable cost, enabling hundreds of millions of doses to be distributed to African countries with high malaria rates. It is based on and is quite similar to Mosquirex, as it contains Novavax’s Matrix-M. Matrix-M is a significant element of several vaccines that are currently in the development stage. The same technology was employed in Novavax’s COVID-19 vaccine.
Malaria remains the most significant cause of death among children, especially in Africa. It is endemic in about 32 African countries, responsible for almost 93% of malaria deaths worldwide. Four African countries- Nigeria, the Democratic Republic of the Congo (DRC), Tanzania, and Niger accounted for more than half of global deaths that occurred due to malaria.
According to a 2021 World Malaria Report, Nigeria, the most populous country on the continent, has the worst malaria situation globally, accounting for 32% of all global deaths and 27% of all malaria cases in 2020. Yet, Nigeria missed the opportunity to participate in the clinical trials due to insufficient infrastructure. Nevertheless, Nigeria followed suit as the NAFDAC, drug controlling agency of Nigeria approved the R21 vaccine in April.
Over 600,000 people die yearly from malaria, primarily newborns and children from Africa. Due to several complexities and a lack of technologies, developing an affordable vaccine against the disease has taken decades. The WHO approved the first malaria vaccine, GSK’s Mosquirix, only two years ago. Unfortunately, demand outnumbers the current production capacity. Therefore, the approval of the second vaccine represents a crucial advancement in the fight against malaria, particularly for Africa.
Going forward, Serum Institute is exploring the possibilities of locally manufacturing the vaccines in Ghana. Local firm DEK Vaccines Ltd., collaborating with the Serum Institute, intends to set up a factory in Ghana’s capital, Accra. They are collaborating to figure out how to produce and finish R21 in Ghana. As of now, Ghana does not make its vaccines. DEK Vaccines Limited, however, is confident and anticipates beginning local production within the next two years.
Today, India is a global powerhouse for pharmaceutical manufacturing. Therefore, India’s experience, manufacturing excellence, and cost-effectiveness are essential for assuring the successful production and marketing of R21. Not only the accessibility of vaccines, but their affordability, particularly in developing nations, is also a crucial factor in the fight against disease. In this sense, Serum Institute has taken a highly significant public pledge to maintain the price of the vaccines at $3 or less. Moreover, the vaccine has a storage life of 24 months if stored in a refrigerator at 2 to 8 degrees Celsius. This is an achievable threshold for developing countries compared to many other vaccines requiring much colder storage.
By 2026 alone, the demand for malaria vaccines is projected to reach 40 to 60 million doses annually. Further, it may cross 80 to 100 million annually by 2030. Whether it is Bharat Biotech or Serum Institute of India, the success of the global distribution of malaria vaccine will depend significantly on India’s vaccine manufacturing prowess. India is currently contributing to around 90% of the world’s demand for the measles vaccination. As a result of this outstanding quality performance, the World Health Organization now sources 65-70% of its measles vaccine supplies from India.
India’s pharmaceutical industry, such as Bharat Biotech and Serum Institute, aims to scale up vaccine manufacturing to satisfy the demands of more African nations with high malaria burdens and thereby support international efforts to save lives. In this regard, future efforts to combat malaria and safeguard poor and vulnerable populations will heavily rely on these Indian vaccine manufacturers.
The opinions expressed in this editorial belong to the author, Samir Bhattacharya, and not necessarily to our publication. We do not guarantee the accuracy or reliability of the information provided. Readers should exercise their own discretion when acting on the content of this article.
