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 in line to benefit, although it is unclear when the rollout will begin.
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.
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Childhood vaccines in Africa are typically paid for by international organisations such as Gavi and UNICEF after they have been backed by the World Health Organization (WHO), which is still assessing the vaccine’s safety and effectiveness.
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 aged five months to 36 months. It has a deal with the Serum Institute of India to produce up to 200 million doses a year.
This is the first time a major vaccine has been approved first in an African country before rich nations, Hill said.
It was unusual that a regulatory authority in Africa had reviewed the data quicker than the WHO, he added.
“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,” Hill said.
The first malaria vaccine, Mosquirix from British drugmaker GSK, was endorsed by the WHO last year after decades of work. But a lack of funding and commercial potential thwarted the company’s capacity to produce as many doses as were needed.
But research has found that the effectiveness of GSK’s vaccine is approximately 60 percent, and significantly wanes over time, even with a booster dose.
Oxford’s R21/Matrix-M vaccine, meanwhile, was found to be 77 percent effective at preventing malaria in research published last year – the first time the WHO’s goal of 75 percent had been met.
Ghana, Kenya and Malawi were all involved in the pilot programme for the rollout of Mosquirix, and have begun distributing it 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 WHO said last month that in the areas where the vaccine has been given, all-cause child mortality has dropped by 10 percent, a sign of its impact.
Mid-stage data from the Oxford vaccine trial involving more than 400 children were published in a medical journal in September.
Vaccine effectiveness was 80 percent in the group that received a higher dose of the immune-boosting adjuvant component of the vaccine, and 70 percent in the lower-dose adjuvant group, at 12 months following the fourth dose.
The doses were administered before peak malaria season in Burkina Faso.
Data from a continuing phase III clinical trial in Burkina Faso, Kenya, Mali and Tanzania, which 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 last six months, Hill said.