Vaccine was up to 80% successful in clinical trials
A much-anticipated malaria vaccine developed by Oxford University has received its first approval in Ghana as the African country intensifies its fight against the disease that claims a child’s life every minute.
The initiative is one of many aimed at combating the mosquito-borne disease that kills more than 600,000 people annually, mostly children in Africa.
“The vaccine has been approved for use in children aged 5-36 months, the age group at highest risk of death from malaria,” the university said in a statement.
Malaria vaccine development has long been hampered by the parasite’s complex structure and lifecycle.
Contrary to other attempts on this front, Oxford’s R21 vaccine appears to be effective. The vaccine was up to 80 per cent successful in clinical trials conducted in Burkina Faso when administered in three initial doses followed by a booster shot a year later.
The final trial data on the vaccine’s safety and efficacy, which has not yet been made public, was evaluated by Ghana’s drug authorities, who then opted to use it. It is also being considered for approval by the World Health Organization.
“It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat malaria,” the university added.
Vaccines for children in Africa are usually contributed by international organisations such as UNICEF after being supported by the World Health Organization (WHO).
This is the first time a major vaccine has been approved first in an African country, before rich nations, Oxford scientist Adrian Hill told news agency Reuters, noting that it was unusual that a regulatory authority in Africa had reviewed the data quicker than the WHO.
“Particularly since COVID-19, African regulators have been taking a much more proactive stance, they’ve been saying...we don’t want to be last in the queue,” he told Reuters.
Ghana has a stable, well-functioning, and integrated regulatory system, according to an external benchmarking conducted by the World Health Organization in 2020, said Javier Guzman, senior policy fellow and director of Global Health Policy at the Center for Global Development.
“This, however, does not mean that donors or international vaccine procurers such as Gavi or UNICEF will fund the vaccine. These agencies still require that the vaccine is considered safe, effective, and quality assured by the World Health Organization prequalification programme,”
Also, it is still uncertain if R21 is good value for money, especially when compared to other cost-effective malaria interventions that have not been fully deployed across endemic countries, such as insecticide-treated nets or indoor residual spraying, Guzman added.
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A separate vaccine developed by British pharmaceutical firm GSK plc was the first to be recommended by WHO for general use against malaria in 2022. It has since been given to more than a million children in Africa.
However, studies have shown that after receiving a booster dosage, the vaccine from GSK only has a 60 per cent efficacy rate. Further, the company’s ability to manufacture the required number of doses has been hindered by a lack of money and economic potential.
The Oxford vaccine, which has received regulatory approval for use in children aged 5 to 36 months, the population at risk, has an edge in manufacturing owing to its agreement with the Serum Institute of India to develop up to 200 million doses yearly.
The development is the “culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most,” Hill told news agency AFP.
In contrast, GSK has committed to producing up to 15 million doses annually through 2028, far less than the estimated 100 million doses a year.
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