On 2nd October, when India celebrated both Gandhi and Lal Bahadur Shastri Jayanti, there was one more reason to celebrate this year. On 2nd October 2023, the World Health Organization (WHO) approved a new vaccine, R21/Matrix-M, to prevent malaria in children.^[1] 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 the WHO approved it.^[2] The vaccine R21 is developed at the University of Oxford and produced by the world’s largest vaccine manufacturer, Serum Institute of India.^[3] The Ghana Food and Drugs Authority (FDA) approved the vaccine for children between five and thirty-six months, ^[4] the age group at the highest risk of death from malaria.

Malaria remains the most significant cause of death among children, especially in Africa. In 2021, Africa accounted for almost 95% of malaria cases and 96% of malaria deaths worldwide.^[5] 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.^[6]

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.^[7] Yet, Nigeria missed the opportunity to participate in the clinical trials due to insufficient infrastructure. Nevertheless, Nigeria became the second country to approve R21 as the NAFDAC the drug controlling agency of Nigeria approved the R21 vaccine in April. ^[8]

Clinical trials for this specific vaccine have been conducted in the UK, Thailand, and various African nations. ^[9] This includes a Phase III experiment with 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania.^[10] Earlier, the 2021 Phase IIb trial data demonstrated 77% effectiveness^[11] and a comforting safety profile after administering three primary doses and a one-year booster. In August, Burkina Faso became the 3rd African country to approve the vaccine before the formal approval from the WHO.^[12] Now, the WHO has approved it for usage, as during the first two phases, the vaccine achieved the WHO-specified 75% effectiveness threshold.^[13]

Before the R21/Matrix-M vaccine, Glaxo SmithKline (GSK) plc developed and manufactured the first malaria vaccine, Mosquirix, also known as RTS, S/AS01.^[14] The project was financially supported by The Bill and Melinda Gates Foundation (BMGF) under the PATH Malaria Vaccine Initiative (MVI).^[15] Since 2019, pilot programmes introducing the RTS,S vaccine have been rolled out in Ghana, Kenya and Malawi, and more than 1.7 million children have already benefitted fromat least one dose of Mosquirix.^[16]

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.^[17] Nine more countries have raised their demand to receive the vaccine. In response to the growing demand, in 2021, GSK entered a product transfer partnership with Indian vaccine manufacturer Bharat Biotech.^[18] However, 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.^[19] On the other hand, the R21 vaccine will be available for use only after mid-2024.^[20]

Both vaccines have been adequately tested and are safe. They have not been put to a side-by-side trial, and there is no direct competition between R21 and RTS, S. Further, there is no evidence so far that one vaccine works more effectively than the other. As per WHO, both vaccines have a similar efficacy rate when given under the same circumstances.^[21] However, according to researchers, R21 will be easier to produce and at a lower cost per dose.^[22] In any case, a country would be free to choose one of the vaccines based on its programmatic factors, availability, and affordability.

In essence, the R21/Matrix-M malaria vaccine is a low-dose vaccine 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.^[23] 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.^[24]

Over 600,000 people die yearly from malaria, primarily newborns and children from Africa.^[25] 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, the demand still 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.^[26] 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. Similarly, Biovaccines Nigeria Limited has signed a contract with Serum Institute for local production. ^[27] The company is a joint venture between the Government of Nigeria and May & Baker Nigeria Plc.^[28]

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. ^[29] Moreover, the vaccine has a storage life of 24 months if stored in a refrigerator at 2 to 8 degrees Celsius.^[30] 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.^[31] Further, it may cross 80 to 100 million annually by 2030. ^[32] Projecting ahead, Serum Institute is prepared to produce 100 million doses per annum immediately and is planning to produce twice as much over the next two years.^[33]

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 currently contributes to around 60% of global vaccine production and 90% of the measles vaccines globally. ^[34] As a matter of fact, 65-70% of WHO measles vaccines are procured from India.^[35] During the COVID-19 outbreak, about 101 countries and two UN entities received more than 282 million vaccine doses of vaccines to COVID-19 vaccines from India.^[36]

Despite the global fight against malaria, every minute, a child under five dies from malaria.^[37] However, most of these deaths can be prevented if treated. Indian 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. Indeed, malaria is not just a matter of public health. It has strong social, economic, and political implications. In this regard, future efforts to combat malaria and safeguard poor and vulnerable populations will heavily rely on these Indian vaccine manufacturers. Clearly, this new vaccine represents a watershed moment for India’s vaccine diplomacy with Africa.

^[1]World Health Organisation. “WHO recommends R21/Matrix-M vaccine for malaria prevention in updated advice on immunization.” October 2, 2023.
https://www.who.int/news/item/02-10-2023-who-recommends-r21-matrix-m-vaccine-for-malaria-prevention-in-updated-advice-on-immunization
^[2]Estelle Shirbon and Alexander Winning. “India's Serum in talks on fill-finishing malaria vaccine in Ghana, official says”. April 20, 2023. https://www.reuters.com/world/africa/who-official-ghana-nigeria-did-not-jump-gun-malaria-vaccine-approval-2023-04-20/
^[3]Bindu Shajan Perappadan. “Oxford-Serum Institute malaria vaccine recommended for use by WHO”. The Hindu. October 2, 2023. https://www.thehindu.com/sci-tech/health/oxford-serum-institute-malaria-vaccine-recommended-for-use-by-who/article67373489.ece
^[4]Robert Barrie. “Ghana becomes first country to approve Oxford’s malaria vaccine”. Pharmaceutical Technology.April 14, 2023. https://www.pharmaceutical-technology.com/news/ghana-becomes-first-country-to-approve-oxfords-malaria-vaccine/
^[5]World Health Organisation. “Malaria”. March 29, 2023. https://www.who.int/news-room/fact-sheets/detail/malaria
^[6]World Health Organisation. “World Malaria Report 2021”. December 6, 2021. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2021
^[7]Ibid
^[8] “Press Briefing by Prof Mojisola Christianah Adeyeye, Director-General National Agency for Food and Drug Administration And Control (NAFDAC) on the Regulatory Approval of R21 Malaria Vaccine by NAFDAC”. NAFDAC. April 17, 2023. https://www.nafdac.gov.ng/press-briefing-by-prof-mojisola-christianah-adeyeye-director-general-national-agency-for-food-and-drug-administration-and-control-nafdac-on-the-regulatory-approval-of-r21-malaria-vaccine-by-nafdac/
^[9]University of Oxford. “R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana”. April 13, 2023.https://www.ox.ac.uk/news/2023-04-13-r21matrix-m-malaria-vaccine-developed-university-oxford-receives-regulatory
^[10]Nigeria Regulator Grants Approval to Oxford's Malaria Vaccine”.Voice of America. April 17, 2023. https://www.voanews.com/a/nigeria-regulator-grants-approval-to-oxford-s-malaria-vaccine/7054297.html
^[11] “Encouraging data of malaria jab trial raise hopes of mass rollout”. Al Jazeera. September 8, 2022. https://www.aljazeera.com/news/2022/9/8/encouraging-data-of-malaria-jab-trial-raise-hopes-of-mass-rollout
^[12] “University Of Oxford’s Malaria Vaccine Receives Regulatory Clearance for Use in Burkina Faso”. India Education Diary. August 9, 2023.
https://indiaeducationdiary.in/university-of-oxfords-malaria-vaccine-receives-regulatory-clearance-for-use-in-burkina-faso/
^[13]University of Oxford. “Malaria booster vaccine continues to meet WHO-specified 75% efficacy goal”. September 8, 2022. https://www.ox.ac.uk/news/2022-09-08-malaria-booster-vaccine-continues-meet-who-specified-75-efficacy-goal
^[14]Chloe Kent “Timeline: malaria vaccines through the ages”. Pharmaceutical Technology. July 19, 2021. https://www.pharmaceutical-technology.com/features/timeline-malaria-vaccines-through-the-ages/
^[15] “Bill Gates Announces $168 Million to Develop Next-Generation Malaria Vaccine”. Bill & Melinda Gates Foundation. September 25, 2008.https://www.gatesfoundation.org/ideas/media-center/press-releases/2008/09/bill-gates-announces-168-million-to-develop-nextgeneration-malaria-vaccine
^[16]University of Oxford.“18 million doses of first-ever malaria vaccine allocated to 12 African countries for 2023–2025: Gavi, WHO and UNICEF”. July 5, 2023. https://www.who.int/news/item/05-07-2023-18-million-doses-of-first-ever-malaria-vaccine-allocated-to-12-african-countries-for-2023-2025--gavi--who-and-unicef
^[17]Soumya Pillai. “12 African countries to get 18 million doses of first-ever malaria vaccine”. Hindustan Times.https://www.hindustantimes.com/india-news/18-million-doses-of-malaria-vaccine-to-be-distributed-across-twelve-african-countries-who-announces-101688668605267.html
^[18]Rhythma Kaul. “Bharat Biotech to produce world’s first malaria vaccine”. Hindustan Times.https://www.hindustantimes.com/india-news/bharat-biotech-to-produce-world-s-first-malaria-vaccine-101633670588611.html
^[19]World Health Organisation. “18 million doses of first-ever malaria vaccine allocated to 12 African countries for 2023–2025: Gavi, WHO and UNICEF”. July 5, 2023. https://www.who.int/news/item/05-07-2023-18-million-doses-of-first-ever-malaria-vaccine-allocated-to-12-african-countries-for-2023-2025--gavi--who-and-unicef
^[20]WHO recommends malaria vaccine made by Oxford University, Serum Institute; roll out expected in mid-2024”. Business Today. October 3, 2023. https://www.businesstoday.in/industry/pharma/story/who-recommends-malaria-vaccine-made-by-oxford-university-serum-institute-roll-out-expected-in-mid-2024-400421-2023-10-03
^[21] “How India-manufactured malaria vaccine will change the fight against killer disease” Firstpost. October 3, 2023. https://www.firstpost.com/explainers/who-second-malaria-vaccine-r21-serum-institute-of-india-oxford-university-13196762.html
^[22]Miryam Naddaf. “Second malaria vaccine to win global approval is cheaper and easier to make”. Nature. October 3, 2023.https://www.nature.com/articles/d41586-023-03115-1
^[23]Bindu Shajan Perappadan. “Oxford-Serum Institute malaria vaccine recommended for use by WHO”. The Hindu. October 2, 2023. https://www.thehindu.com/sci-tech/health/oxford-serum-institute-malaria-vaccine-recommended-for-use-by-who/article67373489.ece
^[24]Akosua Mireku. “EU grants full marketing authorisation for Novavax’s Covid-19 vaccine”. Pharmaceutical Technology. July 7, 2023. https://www.pharmaceutical-technology.com/news/eu-grants-full-marketing-authorisation-novavax-covid-19-vaccine/
^[25]Sarah Boseley. “The new malaria vaccine will prevent many deaths – but it’s by no means the end of the disease”. The Guardian. October 4, 2023. https://www.theguardian.com/global-development/2023/oct/04/the-new-malaria-vaccine-will-prevent-many-deaths-but-its-by-no-means-the-end-of-the-disease
^[26] “Ghana Becomes First Country To Approve Malaria Vaccine Developed By Oxford University”. Sahara Reporters. April 13, 2023. https://saharareporters.com/2023/04/13/ghana-becomes-first-country-approve-malaria-vaccine-developed-oxford-university
^[27] “Africa to Manufacture New Malaria Vaccine?” Health Policy Watch. April 24, 2023. https://healthpolicy-watch.news/africa-to-manufacture-new-malaria-vaccine/
^[28] “Gods gift Onyedinefu. “Biovaccine, May & Baker to open vaccine production facility Q2 2023”.Business Day Nigeria. December 28, 2022. https://businessday.ng/health/article/biovaccine-may-baker-to-open-vaccine-production-facility-q2-2023/
^[29] “Ghana grants national licensure to R21/Matrix-M malaria vaccine”. Health World. April 14, 2023. https://health.economictimes.indiatimes.com/news/industry/ghana-grants-national-licensure-to-r21/matrix-m-malaria-vaccine/99483601
^[30]Fortpied, J., Collignon, S., Moniotte, N. et al. The thermostability of the RTS,S/AS01 malaria vaccine can be increased by co-lyophilizing RTS,S and AS01. Malar J 19, 202 (2020).
^[31]World Health Organisation. “18 million doses of first-ever malaria vaccine allocated to 12 African countries for 2023–2025: Gavi, WHO and UNICEF”. July 5, 2023. https://www.who.int/news/item/05-07-2023-18-million-doses-of-first-ever-malaria-vaccine-allocated-to-12-african-countries-for-2023-2025--gavi--who-and-unicef
^[32]Ibid
^[33] “New malaria vaccine to be a game changer”. The New Indian Express.October 9, 2023. https://www.newindianexpress.com/opinions/editorials/2023/oct/09/new-malaria-vaccine-to-be-a-game-changer-2622078.html
^[34]Subhasis Banerjee. “Evaluating India’s journey to global vaccine dominance”. Financial Express. June 12, 2023. https://www.financialexpress.com/healthcare/pharma-healthcare/evaluating-indias-journey-to-global-vaccine-dominance/3121682/
^[35] “India’s vaccine manufacturing prowess”. Invest India. August 25, 2023. https://www.investindia.gov.in/team-india-blogs/indias-vaccine-manufacturing-prowess
^[36] “India helped over 150 nations in form of Covid vaccines: Rajya Sabha Dy chairman”. Live Mint. January 4, 2023. https://www.livemint.com/news/india/india-helped-over-150-nations-in-form-of-covid-vaccines-rajya-sabha-dy-chairman-11672820542481.html
^[37]UNICEF. “Nearly every minute, a child under 5 dies of malaria”. February 2023. https://data.unicef.org/topic/child-health/malaria/

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