Ghana has granted full national licensure to the R21/Matrix-M™ malaria vaccine, developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SII).
According to the WHO’s 2022 world malaria report, the disease killed 619,000 people in 2021 – with 96% of those deaths in the WHO African region, making malaria one of Africa’s biggest killers.
Ghana, as the first country to approve the R21 vaccine, shows how close the world is to having a second approved vaccine to fight malaria, said Dr. Derrick Sim, Managing Director, Vaccine Markets & Health Security at Gavi, the Vaccine Alliance.
This second vaccine comes alongside the RTS,S vaccine, which was prequalified by the World Health Organization (WHO) in 2022 following a recommendation for its wider use in 2021.
Ghana’s Food and Drugs Authority (FDA Ghana) has assessed trial data and approved the vaccine for use in children aged 5 to 36 months, the age group at highest risk of death from malaria. R21 has a three-dose primary series with a fourth (booster) dose a year later.
“What is important now is to ensure trial data are submitted for a timely SAGE evaluation and eventual WHO decision on prequalification,” said Dr. Sim. R21’s dossier for pre-qualification has been accepted for review by the WHO, and phase III results will be published soon, says a press release from Gavi.
Phrase III trial of the R21 malaria vaccine, which was launched in mid-May 2021 enrolled 4,800 children for one year and follows them up for two more years from 2023-2024. Earlier studies showed the malaria vaccine was 77% effective at preventing malaria over the course of one
year among children aged 5-17 months.
Gavi has already approved funding for a malariavaccine programme and is ready to support adoption of R21 alongside RTS,S. Should the WHO recommend the vaccine’s wider use, Gavi and UNICEF could move to begin funding and procuring doses immediately upon the vaccine’s pre-qualification.
It is also crucial that SII honours public commitments to keep the cost of the vaccine to US$ 3 or less, to enable more people to be protected, said Dr. Sim.
Ghana is one of the first countries to vaccinate against malaria through the pilot malariavaccine implementation programme (MVIP), supported by Gavi – has granted full national licensure to the R21/Matrix-M™ malaria vaccine, developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SII).
Gavi additionally welcomes SII’s announcement of a technology transfer deal to produce the vaccine in Ghana, upon completion of a factory in Accra – which will complement Gavi’s own work with partners including the African Union to support African vaccine manufacturing.
More than 1 million vulnerable children have been reached with the malaria vaccine through the MVIP pilots so far in 2019.