The World Health Organization (WHO) has endorsed R21/Matrix-M, a malaria vaccine developed by a collaboration between the Serum Institute of India (SII) in Pune and the University of Oxford in the United Kingdom. The RTS,S/AS01 vaccine was approved by the WHO in 2021 as the first va ccine against the mosquito-borne disease.

The Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG), independent advisory bodies of WHO, recommended the vaccine's use after reviewing its safety, quality, and effectiveness standards last month. Their recommendation relied on pre-clinical and clinical trial data that demonstrated good safety and high efficacy in four countries with both seasonal and perennial malaria transmission sites.

"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," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement. "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," he added.

R21/Matrix-MTM Malaria Vaccine

The authorities have licensed the R21/Matrix-MTM malaria vaccine for use in Ghana, Nigeria, and Burkina Faso. When combined with public health measures like 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 (where malaria occurs for only 4 or 5 months each year), the R21 vaccine demonstrated a 75 percent reduction in symptomatic malaria cases during the 12 months following a 3-dose series.

The R21 vaccine, administered once a year after the initial three doses, showed a high level of effectiveness, matching the efficacy of RTS,S when administered seasonally. It also showed a 66% efficacy in 12 months. Mathematical modeling estimates suggest the R21 vaccine will significantly improve public health in malaria transmission settings, including those with low rates. With a cost-effectiveness of $2 to $4 per dose, it is comparable to other recommended malaria interventions and childhood vaccines.

"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," said Professor Sir Adrian Hill, Director of The Jenner Institute, at Oxford. SII has notably set up the capacity to produce 100 million doses annually, and this will be expanded twofold within the next two years. This substantial production scale is vital for both curbing the spread of malaria by immunizing high-risk individuals and safeguarding those who receive the vaccine.

"For far too long, malari 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," said Adar Poonawalla, CEO of the Serum Institute of India, in a statement.