Health
Ghana Becomes First Country in the World to Approve Oxford University’s New R21 Malaria Vaccine
Ghana has become the first country in the world to approve a new malaria vaccine from Oxford University.
Key Point:
- Ghana’s FDA becomes the first country to approve a new malaria vaccine known as R21
- This is the first time a major vaccine has been approved in an African country ahead of the developed world.
- Malaria kills over 600,000 people each year, most of them African children.
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.
“WHO can provide support, but it is not an approving agency. The FDA has regulatory authority and that is what we have done,” said the chief executive of the Ghana Food and Drug Administration (FDA). One Delese Darko said.
Darko declined to comment on the timeline for deploying the vaccine. This is because it is organized by Ghana’s health service, the Ghana Malaria Program, and the country’s immunization agency, EPI.
These organizations did not immediately respond to requests for comment.
Mosquito-borne diseases kill more than 600,000 people each year, mostly children in Africa.
Oxford University 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, namely children aged 5 to 36 months. .
The university has contracted with the Serum Institute of India to produce 200 million doses of the vaccine known as R21 annually.
According to Dr. Hill, it is the first time a major vaccine has been approved in an African country, ahead of developed countries.
Experts say it is also rare for vaccines to be approved before data from late-stage trials are made public.
“Especially since COVID, regulators in Africa have taken a much more aggressive stance. They said … we don’t want to be last in line,” said Dr. Hill.
Given the complex structure and life cycle of the malaria parasite, it took decades to develop a malaria vaccine.
The Oxford vaccine is the second vaccine 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 and 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 backs it.
He also 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.
Second vaccine needed to meet demand
The first malaria vaccine, British pharmaceutical company GSK’s Mosquirix, was approved by the WHO last year after decades of research.
However, lack of funding and commercial viability has hampered 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, more than the four-dose vaccine the WHO says is needed in the long term to cover about 25 million children. Well below about 100 million doses per year.
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 has fallen by 10% in areas where the vaccine has been administered. This is a sign 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.
Dr. Hill said the data suggests similar performance to Phase II trials and has been shared with regulators over the past six months.
Reuters
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Sources 2/ https://www.abc.net.au/news/2023-04-14/ghana-first-country-approve-oxford-malaria-vaccine/102226338 The mention sources can contact us to remove/changing this article |
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