Ghana has become the first country in the world to approve the new malaria vaccine developed by Oxford University and the Serum Institute of India PvT Ltd. While Ghana makes up only two per cent of malaria-related deaths, Nigeria, the Democratic Republic of the Congo, Tanzania and Niger account for just over half of all malaria deaths worldwide.
Ghana has become the first country in the world to approve the new malaria vaccine developed by Oxford University and the Serum Institute of India PvT Ltd. The R21/Matrix-MTM malaria vaccine or R21 has been licensed by Ghana’s Food and Drugs Authority and has been approved for use in children aged 5 to 36 months.
According to the 2022 world malaria report, the World Health Organization’s ‘African Region’—with an estimated 234 million cases recorded in 2021—accounted for about 95 per cent of global cases. Children younger than five accounted for about 80 per cent of all malaria deaths in Africa and four African countries accounted for just over half of all malaria deaths worldwide: Nigeria (31.3 per cent), the Democratic Republic of the Congo (12.6 per cent), Tanzania (4.1 per cent) and Niger (3.9 per cent). Ghana made up only 2 per cent of malaria-related deaths.
R21 has demonstrated high levels of efficacy and safety in Phase II trials, including children who received a booster dose of the vaccine a year after following a three-dose vaccination system.
In a statement, Chief investigator, R21/Matrix-M programme, and director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, Professor Adrian Hill, said:
This marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most. I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children. As with the Oxford-AstraZeneca COVID-19 vaccine, our partnership with the Serum Institute of India has been key to successful very large-scale manufacturing and rapid development.
The vaccine was designed and developed at the University of Oxford and has undergone clinical trials in the United Kingdom and Thailand. Across African countries including Burkina Faso, Kenya, Mali and Tanzania, an ongoing phase III trial has seen the enrolment of 4,800 children. The results from these trials are expected to be reported later this year.
Adar Poonawalla, CEO of the Serum Institute of India Pvt Ltd., said:
The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives.
In 2021, the WHO approved RTS, S/AS01 vaccine or Mosquirix from British pharmaceutical company, GlaxoSmithKline (GSK)—the first malaria vaccine. Ghana, Kenya and Malawi were all involved in the pilot programme for the roll-out of Mosquirix and have recently begun introducing it within their countries.
As of September 2022, Mosquirix’s efficacy against the first and only episode of clinical malaria over 12 months after the third dose was 31.1 per cent in infants and 55.8 per cent in children. The R21 vaccine, however, demonstrated high-level efficacy of 77 per cent following 2021 results from the Phase-IIb trial.
At the time of press, there is no available information as to roll out dates for the vaccine in Ghana as regulatory bodies, including the WHO, continue to assess its safety. However, Ghana’s Food and Drug Administration has clarified its position as a regulator and has defended the vaccine’s approval.
‘The WHO can provide support, but it is not an approving institution. The FDA has the mandate as a regulator, and that is what we have done,’ Delese Darko, CEO of Ghana’s Food and Drugs Authority (FDA) told Reuters⎈
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