The approval of the vaccine in Ghana is somewhat unusual because it comes before the release of data from the final phase of the study.
It is unclear when the vaccine will be launched in Ghana as other regulatory bodies, including the World Health Organization (WHO), are still evaluating its safety and effectiveness.
The mosquito-borne disease kills more than 600,000 people each year, most of them children in Africa.
Oxford researcher Adrian Hill said Ghana’s medicines regulator had approved the vaccine nationally for the age group most at risk of dying from malaria – children between the ages of 5 and 36 months.
Oxford has contracted with the Serum Institute of India to produce up to 200 million doses of the vaccine – known as R21 – annually.
This is the first time a major vaccine has been approved in an African country before wealthy nations, Hill said.
Approval of a vaccine before data from late-stage trials is released is also rare, experts told Reuters.
“Especially since COVID, African regulators have taken a much more proactive stance, they’ve said … we don’t want to be last behind,” Hill said.
The first malaria vaccine, Mosquirix from British drugmaker GSK, was approved by the WHO last year after decades of work. But the lack of funding and commercial potential is thwarting GSK’s ability to produce as many doses as needed, demonstrating the need for another candidate.
GSK has committed to producing up to 15 million doses of Mosquirix each year by 2028, far below the roughly 100 million doses a year of the four-dose vaccine that the WHO says are needed in the long term to cover about 25 million children.
Ghana, Kenya and Malawi have all been involved in the pilot program to introduce Mosquirix and have started to introduce it more widely in recent months.
Since it began in 2019, 1.2 million children in the three countries have received at least one dose of the Mosquirix vaccine.
The WHO said last month that in areas where the vaccine was administered, infant mortality from all causes fell by 10 percent, a sign of its impact.
In September, interim data from the Oxford vaccination trial, involving more than 400 young children, was published, showing vaccine effectiveness between 70-80% 12 months after the fourth dose.
Data from an ongoing Phase III clinical trial involving 4,800 children in Burkina Faso, Kenya, Mali and Tanzania are to be published in the coming months.
Hill said the data suggest similar performance to that of the phase II study and have been shared with regulators over the past six months.
Vaccine development has taken decades, given the complicated structure and life cycle of the malaria parasite. The Oxford vaccine is the second in recent years to be approved for use.
Vaccines for children in the poorest parts of Africa are usually co-funded by international organizations such as Gavi, the vaccine alliance, only after receiving WHO approval.
Ghana uses Gavi funding for its vaccination campaigns, although it is moving towards buying its own vaccines after economic growth in recent years.
Dr Derrick Sim, Gavi’s managing director for vaccine markets, said the organization was prepared to provide funding for R21 if the WHO supported it. He said it was crucial to keep the cost below $3, as Serum indicated.
“This shows how close the world is to having a second vaccine approved to fight malaria,” he said.
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