A novel malaria vaccine developed by Oxford University has been approved for use in Ghana, marking a significant development in the fight against the illness that claims the lives of hundreds of thousands of children worldwide every year.
The permission is rare because it occurs before the data from the final stage of the experiment are published.
Since other regulatory authorities, such as the World Health Organisation (WHO), are currently evaluating the vaccine’s safety and efficacy, it is unknown when it might be introduced in Ghana.
Oxford’s Malaria vaccine Program
“The WHO can provide support, but it is not an approving institution. The FDA has the mandate as a regulator, and that is what we have done,” Delese Darko, CEO of Ghana’s Food and Drugs Authority (FDA) told Reuters.
As the Ghana Health Service, the Ghana Malaria Programme, and the nation’s immunisation organisation, the EPI, would organise the vaccine rollout, Darko made no comments about the timescale for its implementation.
Requests for comment from such organisations did not immediately receive a response. More than 600,000 people every year die from the mosquito-borne illness, most of them youngsters in Africa.
The vaccine has been licenced domestically for use in infants aged 5 months to 36 months, who have the highest risk of dying from malaria, according to Oxford scientist Adrian Hill.
Oxford and Serum Institute of India have a contract to produce a maximum of two million doses of the R21 vaccine per year.
According to Hill, this is the first time a significant vaccination has been licenced in an African nation before wealthy ones.
It is also uncommon for a vaccine to be approved before final-stage study data are published, specialists told Reuters.
“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
Given the complex structure and lengthy life cycle of the malaria parasite, vaccine development has lasted for decades. The Oxford shot is the second to have been given the go-ahead in recent years.
Only after receiving WHO clearance can foreign organisations like Gavi, the vaccination alliance, normally co-finance childhood immunisations in the most underdeveloped regions of Africa.
Although Ghana uses Gavi money for its vaccination campaigns, the country is leaning towards purchasing its own injections as a result of recent economic progress.
Dr. Derrick Sim, managing director of vaccination marketing at Gavi, stated that the company was prepared to pay R21 if WHO approved it. According to him, it is imperative that the price remain under $3 as Serum has suggested.
“This shows how close the world is to having a second approved vaccine to fight malaria,” he said.
FULFILLING THE NEED
After decades of development, the first malaria vaccine, Mosquirix from the British pharmaceutical company GSK (GSK.L), was approved by the WHO last year.
However, GSK’s ability to deliver the required number of doses is being hampered by a lack of funding and economic potential, highlighting the need for a different candidate.
Up to 15 million doses of Mosquirix will be produced annually by GSK through 2028, far fewer than the about 100 million doses a year of the four-dose vaccination that the WHO estimates will be required in the long run to protect about 25 million children.
All three countries—Ghana, Kenya, and Malawi—participated in the Mosquirix pilot initiative and have just started rolling it out more broadly.
In all three nations, 1.2 million kids have received at least one dose of the Mosquirix vaccination since it started in 2019.
As evidence of the vaccine’s effectiveness, the WHO reported this month that all-cause infant mortality has decreased by 10% in the regions where it has been distributed.
More than 400 young children participated in the Oxford vaccine experiment, and mid-stage data from the trial showed vaccine efficacy of between 70-80% at 12 months after the fourth dosage.
In the upcoming months, data from a phase III clinical trial being conducted with 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania is expected to be released.
According to Hill, the data, which has been shared with regulatory agencies over the past six months, revealed a similar performance to that in the phase II experiment.
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