Following a successful pilot study encompassing nearly one million children, the World Health Organization (WHO) is now recommending widespread use of the world's first malaria vaccine across all sub-Saharan Africa. It is hoped the landmark vaccine can save tens of thousands of children’s lives over the coming years.
The vaccine, dubbed RTS,S/AS01 (or more recently Mosquirix), is the product of more than 30 years of research. Following expansive clinical trials, a massive pilot program began in 2019 to further validate the vaccine’s efficacy.
The pilot program spanned Malawi, Ghana and Kenya, immunizing more than 800,000 children. A recent WHO evaluation of the ongoing pilot program confirmed the vaccine is safe and effective. The evaluation also found the potentially complex four-dose schedule is a feasible protocol when scaled up to large communities.
“This is a historic moment,” says WHO Director-General Tedros Adhanom Ghebreyesus, who himself started his medical career as a malaria researcher. “The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”
In Africa alone more than 260,000 children die of malaria every year. Concerns have been raised over the efficacy of RTS,S/AS01, with trials finding it only prevents infection in 40 percent of cases, and reduces instances of severe malaria by 30 percent. But even with moderate efficacy a vaccine such as this could prevent a significant amount of death and disease.
The massive pilot program over the past few years also confirmed the vaccine’s safety profile. With over 2.3 million doses now administered researchers can affirm the vaccine is not linked with any previously suspected adverse effects such as meningitis.
Moving forward, the next challenge will be distributing the vaccine across the African continent. Each country’s individual malaria control body will decide if and how they will roll the vaccine out, while the WHO will work with global health organizations including UNICEF, Unitaid, The Global Fund and Gavi, The Vaccine Alliance, to develop funding strategies to ensure the vaccine is efficiently and equitably distributed.
“This vaccine is a welcome new tool that, when used in combination with existing interventions like bed nets, has the potential to drive down malaria and extend protection to children across Africa,” says Unitaid’s executive director, Philippe Duneton. “Pilot implementation has demonstrated how we can equitably reach children with this life-saving vaccine – now we need to ensure adequate and affordable supply to truly reignite the fight against malaria.”