Ghana is the first country in the world to approve a new malaria vaccine, from Oxford University, aimed at children under the age of three, who are most at risk of dying from the disease.
Oxford scientist Adrian Hill said Ghana's drug regulator has approved the vaccine for the age group at highest risk of death from malaria – children aged 5 to 36 months.
It is the first time a major vaccine has been approved in an African country before ahead of rich nations.
Hill said it was unusual that a regulatory authority in Africa had reviewed the data quicker than the World Health Organisation.
"Particularly since Covid, African regulators have been taking a much more proactive stance," he said. "They've been saying...we don't want to be last in the queue."
NEW: Malaria vaccine developed by the University of Oxford receives regulatory clearance for use in Ghana 🇬🇭.
— University of Oxford (@UniofOxford) April 13, 2023
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.
It remains unclear when the Oxford vaccine, named R21/Matrix-M, will actually be rolled out in Ghana.
Childhood vaccines in Africa are typically paid for by international organisations such as Gavi and Unicef after they have been backed by the WHO, which is still assessing the vaccine's safety and effectiveness.
Ghana has a deal with the Serum Institute of India to produce up to 200 million doses annually.
Vaccine production needs boost
Malaria, a 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.
The first, the four-dose Mosquirix, from British drugmaker GlaxoSmithKline, was endorsed by the WHO last year after decades of work.
But a lack of funding and commercial potential meant the company could not produce as many doses as needed.
GSK has committed to produce up to 15 million doses of Mosquirix every year through to 2028, well under the roughly 100 million doses a year the WHO says is needed long term to cover around 25 million children.
Ghana, Kenya and Malawi were all involved in the pilot programme for Mosquirix and have begun rolling it out more widely in recent months.
Since 2019, more than 1.2 million children in the three countries have received at least one dose, which has "resulted in substantial reduction in deadly severe malaria, with a drop in child hospitalisations and child deaths", according to the WHO.
Data from the Oxford vaccine trials involving more than 400 young children was published in September and showed that the vaccine's effectiveness was 80 percent in the group that received a higher dose, and 70 percent in a lower-dose group, after 12 months following a fourth jab.