LONDON (Reuters) – Ghana has become the first country in the world to approve a new malaria vaccine developed by the University of Oxford.
This is unusual as the approval will occur prior to the release of final stage trial data.
It is unclear when the vaccine will be rolled out in Ghana, as other regulatory bodies, including the World Health Organization (WHO), are still evaluating its safety and efficacy.
Mosquito-borne diseases kill more than 600,000 people each year, mostly children in Africa.
Oxford scientist Adrian Hill said Ghana’s drug regulator had approved a vaccine in the country for the age group most at risk of dying from malaria: children aged 5 to 36 months.
The University of Oxford has signed a contract with the Indian Serum Institute to produce 200 million doses per year of the vaccine known as R21.
Hill said this is the first time a major vaccine has been approved in an African country ahead of the developed world. Vaccines are also rarely approved before data from late-stage trials are made public, experts told Reuters.
“Especially since COVID, regulators in Africa have taken a much more aggressive stance and they have said they… don’t want to be last in line,” Hill said.
Given the complex structure and life cycle of the malaria parasite, it took decades to develop a vaccine. The Oxford Shot is his second shot approved for use in recent years.
Childhood vaccines in Africa’s poorest regions are usually co-funded by international organizations such as the Vaccine Alliance Gavi, but only after WHO approval.
Ghana uses Gavi funds for vaccine campaigns, but is moving toward purchasing vaccines on its own in light of recent economic growth.
Dr. Derrick Sim, managing director of vaccine markets at Gavi, said the organization is ready to fund R21 if the WHO supports it. He said it was important to keep costs below $3, as Serum has shown.
“This shows how close the world is to having the second approved vaccine to fight malaria,” he said.
meet the needs
The first malaria vaccine, British pharmaceutical company GSK’s (GSK.L) Mosquirix, was approved by the WHO last year after decades of research. However, a lack of funding and commercial viability has hampered his GSK’s ability to produce the required doses, indicating the need for another candidate.
GSK has pledged to produce up to 15 million doses of Mosquirix each year until 2028, four doses the WHO says are needed in the long term to cover about 25 million children. That’s well below the roughly 100 million annual doses of vaccines.
Ghana, Kenya, and Malawi are all participating in Mosquirix rollout pilot programs and have begun broader adoption in recent months.
Since the start of 2019, 1.2 million children in three countries have received at least one dose of Mosquirix vaccine.
The WHO said last month that all-cause child mortality was reduced by 10% in areas where the vaccine was administered. This is a symptom of its impact.
Interim data from the Oxford Vaccine Trial of more than 400 infants, released in September, showed 70-80% vaccine efficacy 12 months after the fourth dose.
Data from an ongoing Phase III clinical trial of 4,800 children in Burkina Faso, Kenya, Mali and Tanzania are expected to be published in the coming months.
Hill said the data suggests similar performance to Phase II trials and has been shared with regulators over the past six months.
Reporting by Natalie Grover and Jennifer Rigby, Editing by Angus MacSwan
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