While the mosquito-borne disease malaria kills more than 600,000 people each year, a malaria vaccine from Oxford University has been approved for use in Ghana. The West African country is the first in the world where the vaccine can be used.

The complicated structure and lifecycle of the malaria parasite have long stymied efforts to develop vaccines. As a result, the first malaria vaccine, Mosquirix, was endorsed after decades of work in the last year.

For its usage, the Oxford vaccine got regulatory approval in the age group at highest risk of death from malaria, like children aged five months to 36 months.

It is produced by British drug maker GSK, with low capacity to produce the needed doses due to a lack of funding and commercial potential. However, it now has a manufacturing advantage thanks to a deal with the Serum Institute of India to produce up to 200 million doses annually.

In the past, GSK has committed to producing 15 million doses of Mosquirix per year until 2028, which is well below the amount considered necessary by the WHO.

According to the health organisation's most recent statements, approximately 100 million doses of the four-dose vaccine would be required for the long-term supply of the approximately 25 million children affected.

NEW: Malaria vaccine developed by the University of Oxford receives regulatory clearance for use in Ghana 🇬🇭.

The vaccine will be manufactured by @SerumInstIndia using @Novavax's adjuvant technology.

Today marks the vaccine's first regulatory clearance for use in any country.

— University of Oxford (@UniofOxford) April 13, 2023

In September 2022, the mid-stage data results of the Oxford vaccine trial were published, involving over 400 infants. Vaccine efficacy was around 80% in the group that received a higher dose of the immune boosting adjuvant component of the vaccine. In the group receiving the lower dose of the adjuvant, it was 70% effective 12 months after the fourth dose.

Data from the currently ongoing Phase III clinical trial in Burkina Faso, Kenya, Mali, and Tanzania, in which nearly 5000 children have participated, is expected to be published by various medical journals in the coming months.

According to Oxford scientist Adrian Hill, late-phase data have already been submitted in the last six months, suggesting similar vaccine efficacy to the Phase II trial.

Most vaccines for African children are funded by international organisations such as Gavi or UNICEF. This usually happens after the WHO has approved the vaccine.

Hill also points out that this is the first time that a major vaccine has been approved in African countries first, followed by rich countries. He goes on to say that it is unusual for an African regulatory agency to review data faster than the WHO.

"Particularly since Covid, African regulators have been taking a much more proactive stance, they've been saying ... we don't want to be last in the queue," he said.