A second malaria vaccine — R21/Matrix-M — has been recommended by the World Health Organization (WHO) for the prevention of malaria in children. And Indian vaccine makers Serum Institute of India (SII) and Bharat Biotech have a role in the supply of both malaria vaccines.
The second WHO recommendation follows the earlier one to the RTS,S/AS01 vaccine in 2021. Both vaccines are safe and effective in preventing malaria in children and, when implemented broadly, are expected to have high public health impact, said the UN health agency.
The second vaccine was developed by the Jenner Institute at Oxford University and Serum Institute of India (SII), with support from the European and Developing Countries Clinical Trials Partnership, Wellcome Trust, and European Investment Bank, according to SII. The R21/Matrix-M vaccine has been licensed for use in Ghana, Nigeria, and Burkina Faso.
“The vaccine has recently reached the primary one-year endpoint in a pivotal large-scale Phase III clinical trial – funded mainly by the Serum Institute of India, with Oxford University as the regulatory sponsor – including 4,800 children across Burkina Faso, Kenya, Mali and Tanzania. The Phase III trial results are under peer review before publication,” it added.
SII said it has already established production capacity for 100 million doses per annum, which will be doubled over the next two years. A spokesperson said, SII had already produced more than 20 million doses of R21/Matrix-M. “We have a total capacity of 4 billion doses and are using one of our existing facilities for production,” they told businessline.
Tedros Adhanom Ghebreyesus, WHO Director-General, pointed out: “Demand for the RTS,S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster..”
A joint communication earlier this year, the WHO, GAVI and Unicef said, the annual global demand for malaria vaccines is estimated at 40–60 million doses by 2026, growing to 80–100 million doses each year by 2030. “In addition to the RTS,S/AS01 vaccine, developed and produced by GSK, and in the future supplied by Bharat Biotech, it is expected that a second vaccine, R21/Matrix-M, developed by Oxford University and manufactured by Serum Institute of India (SII), could also be prequalified by WHO soon,” they added.
Gavi, the Vaccine Alliance would support the roll out malaria vaccines to 18 countries. The RTS,S vaccine will be rolled out in some African countries in early 2024, and the R21 malaria vaccine is expected to become available to countries mid-2024, WHO said. Malaria places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year, it added.
Key features of the R21 malaria vaccine include, its high efficacy when given before the high transmission season. ”In areas with highly seasonal malaria transmission, the R21 vaccine was shown to reduce symptomatic cases of malaria by 75 percent during the 12 months following a 3-dose series. A fourth dose given a year after the third maintained efficacy. This high efficacy is similar to the efficacy demonstrated when RTS,S is given seasonally, the WHO said.
“At prices of US$ 2 – US$ 4 per dose, the cost-effectiveness of the R21 vaccine would be comparable with other recommended malaria interventions and other childhood vaccines,” it added.
The two WHO-recommended vaccines, R21 and RTS,S, have not been tested in a head-to-head trial, the agency said, adding there is no evidence to date showing one vaccine performs better than the other. “The choice of product to be used in a country should be based on programmatic characteristics, vaccine supply, and vaccine affordability.”
The next step is for the second vaccine to complete the ongoing WHO prequalification, that will allow international procurement of the vaccine for broader rollout. At least 28 countries in Africa plan to introduce a WHO-recommended malaria vaccine as part of their national immunization programmes, the note said.