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Children's getting malaria shot |
Malaria is still one of the biggest problem to global health, effected the lives of nearly 597,000 people in 2023 and causing more than 263 million cases worldwide, according to the latest World Health Organization (WHO) estimates. The African continent carries the heaviest burden, with the WHO African Region alone accounting for 94% of all malaria cases and 95% of deaths. Children under the age of five remain the most vulnerable group, with over 432,000 African children dying from malaria in 2023.
The development malaria immunisation has finally become a reality. Following decades of scientific research, field trials, and international collaborations, two vaccines RTS,S/AS01 (commonly referred to as RTS,S) and R21/Matrix-M (R21) have been recommended by WHO for widespread use in malaria-endemic regions. For the first time in history, the availability of a malaria vaccine means that millions of children in high-risk areas can receive life-saving protection against the disease.
WHO Recommendation and Global Demand
The WHO recommended the RTS,S malaria vaccine in 2021 for children living in areas of moderate to high malaria transmission. This recommendation triggered significant momentum across the global health community, with Gavi, the Vaccine Alliance, committing funding support to effected countries to roll out malaria immunisation.
However, global demand far exceeded the limited supply of RTS,S. To address this, WHO and Gavi developed a transparent allocation framework to ensure fair and equitable vaccine distribution. Research into possible solutions, such as the use of fractionated doses, was also initiated in Kenya and Ghana.
The problem of limited supply was eased in 2023 when WHO recommended the use of a second vaccine - R21/Matrix-M, developed at Oxford University’s Jenner Institute in partnership with the Serum Institute of India. Unlike RTS,S, the R21 vaccine is less expensive, easier to produce at scale, and has demonstrated high efficacy in seasonal malaria transmission areas.
RTS,S Malaria Vaccine
The RTS,S malaria shot was the first to reach the stage of large-scale pilot implementation. Between 2019 and 2023, the Malaria Vaccine Implementation Programme (MVIP) was conducted in Ghana, Kenya, and Malawi. More than 2 million children were vaccinated, resulting in a 13% reduction in all-cause child mortality among those eligible for the vaccine and a significant decline in hospitalisations for severe malaria.
The RTS,S vaccine was pre-qualified by WHO in July 2022, ensuring its safety, efficacy, and quality. Administered in a schedule of four doses beginning at around five months of age, RTS,S provided protection against malaria during the critical early years of life. A fifth booster dose one year after the fourth was shown to extend protection in high-risk, highly seasonal settings.
R21/Matrix-M
The introduction of R21/Matrix-M in 2023 marked a turning point. This vaccine was developed with the goal of producing a safe, cost-effective, and highly efficacious solution. Clinical trials demonstrated that R21 provides up to 75% efficacy when administered seasonally in high-transmission areas.
WHO’s recommendation of R21 was based on evidence from Phase 2 and 3 trials conducted in Ghana, Burkina Faso, Kenya, and other countries, which confirmed both its safety and its effectiveness in reducing malaria episodes. Unlike RTS,S, R21 is more affordable and easier to manufacture in bulk, largely because it is produced by the Serum Institute of India, the world’s largest vaccine manufacturer.
WHO pre-qualified R21 in December 2023, paving the way for its rapid adoption by malaria-endemic countries. The presence of two WHO pre-qualified vaccines - RTS,S and R21 has ensured a sufficient global supply of malaria vaccines, enabling countries to integrate malaria immunisation into routine childhood vaccination schedules.
How the Vaccines Compare
Both RTS,S and R21 have proven safe and effective, but they have not been tested against each other in direct head-to-head trials. Studies show that:
- Both vaccines reduce malaria episodes by more than 50% in the first year after vaccination.
- With seasonal administration, they can prevent around 75% of malaria cases when combined with chemoprevention.
- A four-dose regimen is required for optimal protection, with an optional fifth booster in high-risk areas.
- RTS,S was the first vaccine to demonstrate large-scale public health impact, while R21 offers an affordable alternative with potentially wider reach.
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The choice between RTS,S and R21 often depends on vaccine availability, programmatic feasibility, and cost considerations. With Gavi’s co-financing mechanism, many low-income countries can access malaria vaccines at subsidized rates as low as US$0.20 per dose.
India’s Role in Malaria Vaccine Development
India also plays a critical role in malaria vaccine development and distribution. India has historically carried a significant malaria burden, with transmission concentrated in tribal, forested, and border regions. Though India has made progress in reducing malaria cases through vector control and improved diagnostics, the disease continues to pose risks in states such as Odisha, Chhattisgarh, Jharkhand, and the northeastern region.
India is central to global malaria immunisation efforts through the Serum Institute of India, which is mass-producing the R21 malaria vaccine. By leveraging its world-class manufacturing capacity, India is enabling large-scale production and affordable distribution of vaccines to malaria-endemic countries worldwide.
Additionally, India is developing its own malaria vaccine candidate, AdFalciVax. This multi-stage vaccine, being developed by the Indian Council of Medical Research (ICMR) in partnership with the Department of Biotechnology - National Institute of Immunology (DBT-NII), is designed to target multiple stages of the Plasmodium falciparum parasite, the most deadly malaria strain. AdFalciVax aims not only to prevent infection but also to reduce transmission, making it a powerful tool for future malaria elimination efforts.
As an indigenously developed vaccine under the Make in India initiative, AdFalciVax represents India’s growing leadership in vaccine innovation. Though still in early pre-clinical stages, the vaccine has shown strong results and is expected to move into further trials in the coming years.
Vaccine Implementation
By April 2025, 19 countries had already introduced malaria vaccines sub-nationally, with broader rollouts expected during the year. Early results show that both RTS,S and R21 are already saving tens of thousands of lives annually.
The MVIP pilot programmes in Ghana, Kenya, and Malawi provided critical evidence of the vaccine’s real-world effectiveness, demonstrating not only reduced deaths but also fewer hospital admissions and a measurable decline in severe malaria cases. These outcomes reinforced the value of malaria immunisation as part of a broader strategy to reduce the global malaria burden.
Global health agencies estimate that if malaria vaccination is scaled up across endemic regions, it could prevent half a million child deaths by 2035.
Cost and Accessibility
The affordability of malaria vaccines is a crucial factor in their rollout. Gavi, the Vaccine Alliance, has created an exceptional time-limited co-financing policy for malaria vaccines. This ensures that even low-income countries can access the vaccines at minimal cost. Studies show that both RTS,S and R21 are highly cost-effective, comparable to or even more effective than other established child vaccination programs.
With R21 being less expensive than RTS,S, and with India’s Serum Institute scaling up production, the expectation is that supply constraints will no longer hinder global malaria vaccination campaigns.
Implications for India and Asia
Everyone's focus has been on Africa, malaria remains a significant challenge in parts of South Asia, Southeast Asia, and Latin America. India, with its vast population and varied transmission patterns, stands to benefit greatly from malaria immunisation programs.
India’s malaria control strategy currently relies heavily on mosquito vector control and rapid diagnostic testing. However, vaccination for malaria disease could provide an additional layer of protection, particularly in high-risk tribal and forested areas where healthcare access is limited.
Experts believe that the malaria vaccines in India could reduce case numbers dramatically, accelerate progress toward elimination targets, and contribute to the National Framework for Malaria Elimination (NFME) 2030, which envisions a malaria-free India by 2030.
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