The vaccine, called R21, is only the second to be authorised for use by regulators, and there are high hopes that it will play a significant role in combating a pathogen that still kills more than 600,000 people every year – the vast majority children under five in Africa.
According to the University of Oxford, Ghana’s Food and Drugs Authority has approved the shot for use in children between five and 36 months old, becoming the first to give the shot a green light for use outside trials.
Final data from an ongoing phase three trial in almost 5,000 children – which was set to help determine the length of protection and whether boosters will be needed – has yet to be published. But scientists said they have already shared findings with regulatory agencies.
Previous data has been promising. A phase two trial in 450 volunteers found R21 was 77 per cent effective against the disease in areas where malaria is seasonal, with no safety red flags. Further data published last summer found that a booster dose a year after the initial three shots meant efficacy remained as high as 80 per cent 12 months later.
Scientists said that the phase three results were similar. While it is unusual for African countries to approve new vaccines before the World Health Organisation (WHO) – which is currently reviewing the data – Prof Adrian Hill, director of the Jenner Institute at the University of Oxford, said the pandemic vaccine scramble has shifted the dynamic.
“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,” he told Reuters.
Developing jabs to combat the ancient killer has been notoriously difficult due to the malaria parasite’s complicated life cycle and its ability to avoid detection by the immune system.
Well over 100 candidates have been trialled, but last October – after 35 years of development and $200 million (£160 million) – GSK’s RTS,S shot was the first to receive a green light. It was a major step forward, but efficacy is well below the WHO’s target of 75 per cent and the vaccine isn’t cheap.
Supply is also likely to remain constrained for several years, as a lack of funding has hampered GSK’s ability to mass produce the shot. The company has committed to produce up to 15 million doses every year until 2028, which is substantially lower than the 100m that the WHO says is needed to protect around 25 million children in the long term.
According to R21’s proponents, this vaccine is a more powerful, more modern, more scalable version of RTS,S, because it was “designed in 2012, not in the 1980s and 1990s”.
The team has also secured a deal with the Serum Institute of India to produce up to 200 million doses annually, with each shot costing a couple of dollars. Adar Poonawalla, the company’s chief executive, said Ghana’s approval was a “significant milestone in our efforts to combat malaria around the world”.
Last autumn, Prof Hill told the Telegraph that the trial results so far have been “really exciting” and could help reduce malaria deaths by 70 per cent.
“Priority one is to protect children, who die in huge numbers,” he added. “We also know that in principle, and hopefully in practice, we will be able to eradicate malaria, but we can’t do that with the current tools.
“Having this vaccine, or other improved vaccines later on, will be the key intervention… despite interventions [including bednets and spraying] and $3 billion being spent each year on them, we’re still left with this horrendous mortality in children dying from malaria in Africa. If we can get 200m doses at $3 each… the benefits are obvious.”
But questions around money remain. While malaria is better funded than many diseases, it is constrained – rolling out any new tool will likely lead to shifts in budgets. The WHO is trawling through the data to analyse whether the benefits of the vaccine outweigh the risks or costs, but it is not clear how long that process will take.