New Delhi, October 3: The World Health Organization (WHO) has issued a recommendation for the use of a cost-effective and highly efficient malaria vaccine developed in collaboration between the Pune-based Serum Institute of India (SII) and the University of Oxford in the UK.

The R21/Matrix-M malaria vaccine has now become the second WHO-recommended vaccine for preventing malaria in children. In 2021, the RTS,S/AS01 vaccine was the first to receive WHO approval as a vaccine against malaria.

The recommendation for the R21/Matrix-M vaccine was made by the WHO’s independent advisory body, the Strategic Advisory Group of Experts (SAGE), and the Malaria Policy Advisory Group (MPAG) after assessing its safety, quality, and effectiveness standards last month.

The decision to recommend this vaccine was based on pre-clinical and clinical trial data that demonstrated good safety and high efficacy in four countries, including areas with both seasonal and perennial malaria transmission.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, expressed his excitement, saying, “As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two. Demand for the RTS,S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster and to bring us closer to our vision of a malaria-free future.”

The R21/Matrix-M malaria vaccine has received licensure for use in Ghana, Nigeria, and Burkina Faso. When combined with public health measures such as the use of insecticide-treated bed nets, this new vaccine has the potential to save and enhance the lives of millions of children and their families.

In regions with highly seasonal malaria transmission, the R21 vaccine has shown a 75 percent reduction in symptomatic malaria cases during the 12 months following a 3-dose series. A fourth dose administered a year after the third maintains efficacy, similar to seasonal RTS,S administration.

The vaccine also demonstrated good efficacy (66 percent) during the 12 months following the first 3 doses, with the fourth dose maintaining efficacy.

Mathematical modeling estimates suggest that the R21 vaccine will have a significant public health impact in a variety of malaria transmission settings, including low-transmission areas.

With a cost ranging from $2 to $4 per dose, the cost-effectiveness of the R21 vaccine is comparable to other recommended malaria interventions and childhood vaccines.

Professor Sir Adrian Hill, Director of The Jenner Institute at Oxford, emphasized, “The R21/Matrix-M malaria vaccine is easily deployable, cost-effective, and affordable, ready for distribution in areas where it is needed most, with the potential to save hundreds of thousands of lives a year.”

SII has already established production capacity for 100 million doses per annum, with plans to double this production over the next two years. Such large-scale production is crucial for vaccinating high-risk malaria populations, curbing the spread of the disease, and protecting the vaccinated.

Adar Poonawalla, CEO of the Serum Institute of India, expressed the significance of this milestone, saying, “For far too long, malaria has threatened the lives of billions of people across the globe, disproportionately affecting the most vulnerable amongst us. This is why the WHO recommendation and approval of the R21/Matrix-M vaccine marks a huge milestone on our journey to combat this life-threatening disease.”

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