Ghana approves deployment of world's second Malaria vaccine

Ghana has approved for use of the world's second Malaria vaccine, a move that has been hailed as a potential game changer in the fight against the parasitic disease.

The R21/Matrix-M vaccine, commonly called R21, was developed by the University of Oxford and manufactured by the Serum Institute of India Pvt Ltd (SIIPL). The researchers say it will potentially reduce over half a million malaria-related deaths annually and improve the health outcomes of millions of people, particularly in Africa. Malaria is transmitted by mosquitoes.

According to data from the World Health Organization (WHO), Africa bears the highest burden of disease in terms of both morbidity and mortality.

About 600, 000 deaths are recorded annually from the disease, most of them in Africa, according to WHO.

R21 was approved by the Ghana Food and Drugs Authority (FDA) for use in children aged 5 to 36 months, the age group said to be at the highest risk of death from malaria.

"It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat malaria," the manufacturer and researchers said in a joint statement released on Thursday.

R21 was trialled in three phases, in about a dozen countries, including the UK, Thailand, and several African countries.

The third phase of the trial is currently ongoing in Burkina Faso, Kenya, Mali and Tanzania, involving 4,800 children enrolled.

The researchers said the results from this phase are expected to be reported later this year.

One group of children who took part in the study received a booster dose at one year.

The researchers also said that the vaccine continues to meet the WHO World Health's Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy.

During a phase two trial, the efficacy went as high as 77%.

But the approval of the vaccine comes before the publication of the results of the final phase of its trial. And it is the first time an African country has approved a vaccine before it reached its final stage of trial.

Ghanaian authorities defended the decision

FDA’s Chief Executive, Dr Mimi Delese Darko, told the local press in Accra that the approval was granted following an extensive series of reviews and thorough peer-reviews of the non-clinical and clinical quality parts of the vaccine product development dossier.

Dr Darko further explained that the evaluation and approval process considered the safety, immunogenicity and efficacy data generated from five main clinical trials conducted in the participating countries.

“Thus, the approval of the vaccine was based on a satisfactory evaluation outcome of the quality, safety and efficacy data submitted to the FDA," she stressed, adding: “The evaluation of the submission concluded that the benefit of the vaccine significantly outweighs the risk associated with the use of the vaccine.”

Vaccines generally take long time to develop. But the malaria vaccine has taken even longer due to what experts attribute to the complexity of the parasite involved.

The R21 will be the second Malaria vaccine when it is approved by WHO, which says it is currently assessing available data.

The first malaria vaccine - Mosquitrix, manufactured by the British drugmaker, GSK - was approved by WHO in 2022.

There are more than a dozen Malaria vaccine candidates under development, according to the US Centers for Disease Control and Prevention (CDC).

The R21/Matrix-M stands out for its lower cost of production.