Ghana – one of the first countries to vaccinate against malaria through the pilot malaria vaccine 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).
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. 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. Alongside existing interventions, this vaccine will help save more lives.
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.
R21’s dossier for pre-qualification has been accepted for review by the WHO, and we expect that phase III results will be published soon. 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. Gavi has already approved funding for a malaria vaccine programme and is ready to support adoption of R21 alongside RTS,S.
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 here).
Dr. Derrick Sim, Managing Director, Vaccine Markets & Health Security at Gavi, the Vaccine Alliance, commented on Ghana’s decision:
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. Gavi is ready to provide funding for R21. What is important now is to ensure trial data are submitted for a timely SAGE evaluation and eventual WHO decision on prequalification. 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.
More than 1 million vulnerable children have been reached with the malaria vaccine through the MVIP pilots so far in 2019. Find out more about the malaria vaccine implementation programme here.
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.
R21’s dossier for pre-qualification has been accepted for review by the WHO, and we expect that phase III results will be published soon. 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. Gavi has already approved funding for a malaria vaccine programme and is ready to support adoption of R21 alongside RTS,S.
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 here).
Dr. Derrick Sim, Managing Director, Vaccine Markets & Health Security at Gavi, the Vaccine Alliance, commented on Ghana’s decision:
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. Gavi is ready to provide funding for R21. What is important now is to ensure trial data are submitted for a timely SAGE evaluation and eventual WHO decision on prequalification. 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.
More than 1 million vulnerable children have been reached with the malaria vaccine through the MVIP pilots so far in 2019. Find out more about the malaria vaccine implementation programme here.
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