Ghana has become the first country in the world to approve a new malaria vaccine developed by Oxford University.
R21/Matrix-M was shown to be up to 80% effective in a trial involving 400 children in Burkina Faso, published in September.
Malaria kills more than 600,000 people each year, most of them children in Africa, and the search for a vaccine has been going on for decades.
One child under the age of five dies from the mosquito-borne disease every 75 seconds, despite the use of bed nets, preventative drugs and insecticide sprays.
The drugs authority in Ghana has now signed off the vaccine after seeing results of a larger phase-three trial involving 4,800 children in Burkina Faso, Kenya, Mali and Tanzania.
Those results are expected to be made public in a medical journal in the coming months as the World Health Organization finishes its own assessment.
If the WHO approves it, organisations such as Unicef and the vaccine alliance Gavi could fund millions of doses.
Oxford scientist Professor Adrian Hill, head of the R21 programme at the Jenner Institute, said Ghana had approved R21 for children aged five months to 36 months – the highest risk category.
A deal for up to 200 million annual doses has also been agreed with the Serum Institute of India.
The vaccine has been administered in trials as three doses four weeks apart and a booster a year later.
Professor Hill said the larger phase-three trial also showed “high levels of efficacy and a reassuring safety profile” – and it’s this result that appears to have given Ghana the confidence to approve R21.
It is the first time a major vaccine has been approved in an African country ahead of rich nations, said Prof Hill.
“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.
It is not yet known when the West African country will begin rolling out the vaccine.
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The first malaria vaccine, Mosquirix, by UK drugs giant GSK, was approved by the WHO last year but its roll out has been limited by commercial potential and a lack of funding.
GSK has promised to make up to 15 million doses per year until 2028, but it’s far short of the 100 million or so doses the WHO says are needed to cover 25 million children.
So far, around 1.2 million children in Kenya, Ghana and Malawi have had at least one doses of Mosquirix as part of a pilot that began in 2019.
In the areas where it has been administered, the WHO says all-cause child mortality has fallen by 10%.