Ghana becomes first country to approve Oxford’s malaria vaccine

Ghana has become the first country to approve a new malaria vaccine – called R21 – from Oxford University. Ghana’s drug regulator has approved the vaccine domestically for the age group at highest risk of death from malaria – children aged 5 months to 36 months.

Malaria remains a deadly disease in Sub-Saharan Africa. Every year, there are over 200 million global cases of malaria, resulting in over 600,000 deaths annually. It is a serious, sometimes fatal, illness that is caused by a parasite and transferred to humans through mosquito bites. Malaria is most commonly transmitted by the bite of a female mosquito of the genus Anopheles.

This is the first time the Oxford vaccine has received regulatory approval anywhere in the world.

According to the university in a statement, “the vaccine has been approved for use in children aged 5-36 months, the age group at 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,” it added.

In September last year, a medical journal published mid-stage data from the Oxford vaccine trial, which included over 400 young children. The vaccine was found to be 80% effective in the group that received a higher dose of the immune-boosting adjuvant component, and 70% effective in the group that received a lower dose of the adjuvant, at 12 months after the fourth dose.

These doses were given before the peak malaria season in Burkina Faso.

Currently, an ongoing phase III clinical trial in Burkina Faso, Kenya, Mali, and Tanzania has enrolled 4,800 children, and data from this trial is expected to be published in a medical journal in the coming months.

The World Health Organization (WHO) endorsed the first malaria vaccine, Mosquirix, from British drugmaker GSK last year, following decades of work. However, GSK’s capacity to produce sufficient doses has been hampered by a lack of funding and commercial potential. Despite being administered to over a million children in Africa, research indicates that its efficacy of about 60% diminishes significantly over time.

On the other hand, the Oxford vaccine holds a manufacturing advantage, as it has signed a deal with the Serum Institute of India to manufacture up to 200 million doses each year. In contrast, GSK has committed to producing only up to 15 million doses of Mosquirix per year until 2028.

This is significantly lower than the roughly 100 million doses per year of the four-dose vaccine that the WHO recommends as a long-term solution, to cover about 25 million children.

Though approved, it is however unclear when the vaccine may be rolled out in Ghana as other regulatory bodies, including the World Health Organization (WHO), are still assessing its safety and effectiveness.