Malaria, Ghana approves a new vaccine
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Ghana took the first step: the regulatory authority of the African country announced that it had given the green light to R-21/Matrix-M, the second vaccine available against malaria (after RTS,S/AS01, approved in 2021) but the first to exceed the 75 percent efficacy threshold set by the World Health Organization. The new vaccine was developed by a group of researchers at the University of Oxford’s Jenner Institute, and has been approved for use in children aged between 5 and 36 months, the age group at the highest risk of death for malaria. Administration involves a series of three doses with a fourth dose one year apart.
The approval of the new vaccine marks a turning point in the fight against malaria, a disease which according to the latest World Malaria Report killed over 600,000 people in 2021, mainly in Africa. In fact, the highest numbers are concentrated here, given that four countries account for just over half of all deaths: Nigeria (31%), the Democratic Republic of the Congo (13%), Niger (4%) and the United Republic of Tanzania (4 %).
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A multi-handed job
The vaccine is the result of a truly global effort. The researchers from the United Kingdom have in fact used a technology from Novavax, the US company that produces a vaccine against the coronavirus. We are talking about Matrix-M, a saponin-based adjuvant that improves the response of the immune system, making it more effective and prolonged over time. The Serum Institute, an Indian biotechnology company, will instead produce and market the new vaccine.
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Efficacy and safety
To assess its safety and efficacy, the vaccine has undergone clinical trials in the UK, Thailand and several African countries, including a phase III study in Burkina Faso, Kenya, Mali and Tanzania involving 4,800 children . The results of the latter trial will be published by the end of the year, but the researchers already let it be known that the vaccine shows high levels of efficacy and a good safety profile. However, the phase IIb study conducted in 2021 had yielded promising results, the researchers from the University of Oxford recall: a booster dose of the new R21/Matrix-M vaccine at one year, after the primary three-dose regimen, had maintained a ‘high protection against the disease, reaching and exceeding the target set by the WHO, set at an efficacy of 75 percent.
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Waiting for the WHO go-ahead
The approval by the Ghanaian authorities, commented Adrian Hill, director of the Jenner Institute at the University of Oxford and head of the R21/Matrix-M programme, “marks the culmination of 30 years of malaria vaccine research in our Institute, with the development of a highly effective vaccine that can be produced on a large scale at a modest cost, and distributed rapidly to the countries that need it most”. The Serum Institute has in fact ensured that it can distribute over 200 million doses a year, also thanks to agreements with local companies for future production directly in Ghana and other African countries.
“The approval of the R21 vaccine by the Ghanaian authorities – commented Derrick Sim, director of the Vaccine Markets & Health Security area of Gavi – the Vaccine Alliance, the public-private partnership that promotes vaccinations against various deadly diseases – shows that the world is about to have a second malaria vaccine available. Now it is important that the trial data is published quickly so that WHO can evaluate the quality, safety and efficacy of the product. It is also essential that the Serum Institute honor public commitments and keep the cost of the vaccine at $3, so as to allow more people to be protected “.
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