Ghana has become the first country in the world to approve a new malaria vaccine from Oxford University, with children under the age of three years in line to benefit.
The mosquito-borne disease kills more than 600,000 people each year, most of them children in Africa, and scientists have been trying for years to develop vaccines.
It is unclear when the Oxford vaccine will be rolled out in Ghana.
Childhood vaccines in Africa are typically paid for by international organizations such as the vaccine alliance Gavi and Unicef after they have been backed by the World Health Organisation (WHO), which is still assessing the vaccine’s safety and effectiveness.
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However, Oxford scientist Adrian Hill said Ghana’s drug regulator has approved it for the age group at the highest risk of death from malaria — children five months to 36 months old. It has a deal with the Serum Institute of India to produce up to 200 million doses annually.
This is the first time an important vaccine has been approved first in an African country ahead of rich countries, Hill said. It is unusual that a regulatory authority in Africa has reviewed the data quicker than the WHO, he said.
“Particularly since Covid-19, African regulators have been taking a much more proactive stance, they’ve been saying … we don’t want to be last in the queue,” Hill said.
The WHO endorsed the first malaria vaccine, Mosquirix from British drugmaker GSK in 2022 after decades of work. But a lack of funding and commercial potential thwarted the company’s capacity to produce as many dose as needed.
GSK has committed to produce up to 15 million doses of Mosquirix every year until end-2028, well under the roughly 100 million doses a year of the four-dose vaccine the WHO says is needed long-term to cover about 25-million children.
Ghana, Kenya and Malawi were all involved in the pilot program for Mosquirix rollout, and have begun rolling it out more widely in recent months.
Since it began in 2019, 1.2 million children across the three countries have received at least one dose of the vaccine, and the WHO said in March that in the areas where the vaccine has been given, all-cause child mortality has dropped 10%, a sign of its impact.
Midstage data from the Oxford vaccine trial involving more than 400 young children was published in a medical journal in September.
Vaccine effectiveness was 80% in the group that received a higher dose of the immune-boosting adjuvant component of the vaccine, and 70% in the lower-dose adjuvant group, at 12 months after the fourth dose. The doses were administered ahead of peak malaria season in Burkina Faso.
Data from an ongoing phase III clinical trial in Burkina Faso, Kenya, Mali and Tanzania that has enrolled 4,800 children is expected to be published in a medical journal in the coming months.
However, late-stage data — which suggests a similar vaccine performance as in the phase II trial — has been shared with regulatory authorities over the past six months, Hill said.