Ghana has become the first country in the world to approve a new malaria vaccine developed by Oxford University.
R21/Matrix-M Yes Show effective rate up to 80% In a trial published in September involving 400 children in Burkina Faso.
malaria More than 600,000 people die each year, most of them children in Africa, and the search for a vaccine has been underway for decades.
Despite the use of bed nets, preventive medicines and insecticides, every 75 seconds a child under the age of 5 dies from a mosquito-borne disease.
The Ghana Medicines Regulatory Authority has now approved the vaccine after seeing results from a larger phase 3 trial involving 4,800 children in Burkina Faso, Kenya, Mali and Tanzania.
The results are expected to be published in medical journals in the coming months as the World Health Organization completes its own assessment.
Organizations such as UNICEF and Gavi, the vaccine alliance, could fund millions of doses of the vaccine if the World Health Organization approves it.
Professor Adrian Hill, a scientist at the University of Oxford and head of the R21 project at the Jenner Institute, said Ghana had approved R21 for use in children aged five to 36 months – the highest risk category.
There is also an agreement with the Serum Institute of India for up to 200 million doses per year.
The vaccine has been given in trials in three doses 4 weeks apart with a booster dose a year later.
Professor Hill said the larger phase 3 trial had also shown “a high level of efficacy and a reassuring safety profile” – the very results that seemed to give Ghana the confidence to approve R21.
Professor Hill said it was the first time an African country had approved a major vaccine ahead of richer nations.
“Especially since COVID, African regulators have been taking a more proactive stance and they’ve been saying … we don’t want to be last,” he said.
It is unclear when the West African country will start rolling out the vaccine.
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The first malaria vaccine, Mosquirix, was developed by British pharmaceutical giant GlaxoSmithKline (GSK) Approved by the World Health Organization last year But its rollout has been limited by commercial potential and a lack of funding.
GSK has pledged to produce up to 15 million doses of the vaccine a year by 2028, but that is far short of the roughly 100 million doses the WHO says it needs to cover 25 million children.
So far, about 1.2 million children in Kenya, Ghana and Malawi have received at least one dose of Mosquirix as part of a pilot program that began in 2019.
All-cause child mortality fell by 10 percent in areas where the drug was implemented, the World Health Organization said.