Ghana has become the first country to approve an effective malaria vaccine developed by the Oxford University in the UK. The R21/Matrix-M vaccine, the first one to exceed the World Health Organization’s target of 75% efficacy, has been authorized for use in children aged 5-36 months, the group at the highest risk of death from the disease.

The country’s Food and Drugs Authority (FDA) analyzed the final trial data on the vaccine’s safety and effectiveness, which isn’t yet public, and decided to use it. The WHO has yet to recommend the widespread use of the R21 vaccine, and until it does there’s a question mark over the amount of international funding available for its rollout.

“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 told Reuters. The vaccine rollout will be organized by the country’s health service, its malaria program and the immunization body, he added.

A very challenging disease

Plasmodium, a parasite transmitted through mosquito bites, is the root cause of malaria in humans. Among the five species capable of causing malaria, two pose the greatest threat. Symptoms typically manifest 15 days post-bite, and without prompt treatment, the illness can progress to a severe state and, in some cases, prove fatal.

It’s both a preventable and treatable disease. Over 90% of all the cases and deaths are concentrated in Africa, according to the WHO. In recent years, countries have made progress using new tools such as insecticide-treated mosquito nets. A recent study found a natural treatment that could make people almost invisible to mosquitoes.

Last year, the WHO endorsed Mosquirix, the first malaria vaccine developed by the pharmaceutical company GSK, after decades of work. However, due to insufficient funding, GSK was unable to produce the required number of doses. Studies have shown that the vaccine’s effectiveness is around 60% and decreases over time.

Ghana, Kenya, and Malawi participated in the pilot program for the rollout of Mosquirix and have since started distributing it more widely, with 1.2 million children having received at least one dose across the three countries since 2019. Child mortality from all causes has decreased by 10% in the areas where the vaccine was administered.

Oxford’s R21 vaccine showed 80% effectiveness in preventing malaria in a study published last year, meeting the WHO’s goal of 75% efficacy for the first time. Further data from a continuing phase III clinical trial involving 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania are due to be published in a journal in the next few months.

Oxford scientist Adrian Hill told BBC that R21 will “make a major impact on malaria mortality in the coming years,” contributing in the longer term to the goal of malaria eradication. This is the first time a major vaccine has been approved by an African country before rich nations, Hill said, with African regulators “taking a more proactive stance.”

The Serum Institute of India, with which Oxford has signed an agreement, is now getting ready to produce up to 200 million doses per year, with a vaccine factory being built in Accra, Ghana. Adar Poonawalla, the CEO of the institute, told BBC that Ghana represents a “significant milestone” in the efforts to tackle malaria around the world.