The World Health Organization, acting on a recommendation from its scientific advisers, announced Wednesday that it would broadly roll out a much-needed malaria vaccine, saying pilot testing had shown that it was safe and could be effectively deployed in remote and rural settings.
The decision, which was announced by WHO Director-General Tedros Adhanom Ghebreyesus, marks a landmark moment in the fight against malaria, for which no other vaccines exist. The disease killed roughly 400,000 people in 2019 — the most recent year for which statistics are available — mostly in sub-Saharan Africa. The biggest toll is on young children; an estimated 279,000 children under the age of 5 died from malaria in 2019.
“As some of you may know, I started my career as a malaria researcher, and I longed for the day that we would have an effective vaccine against this ancient and terrible disease,” Tedros said during a news conference from Geneva. “Today is that day, an historic day.”
He said he believed the vaccine — the first for a human parasite — would save tens of thousands of lives.
The vaccine, known as RTS,S and developed by GSK, is given in four doses. The complexity of delivering a four-dose regimen in low-resource settings had raised concerns about how useful the vaccine could be in the real world. For that reason, the WHO’s vaccine advisers previously recommended the vaccine be used first in a pilot program. That program began in 2019, with Ghana, Kenya, and Malawi deploying the vaccine.
All three countries gave the first three shots of the vaccine at monthly intervals starting at either 5 or 6 months of age, with the last given 18 months or so after the first — around a child’s second birthday. While the initial doses are given at the time other vaccines are administered, the last is not. It was feared that in remote and rural settings, parents might not bring their children back in for a final dose of the vaccine, limiting the vaccine’s usefulness.
Another fear was that parents might assume the vaccine, which only offers partial protection, was more potent than it actually is and as a result, might let down their guard on other malaria prevention measures such as having children sleep under a treated bed net.
Tedros said the pilot program confirmed that the vaccine can be effectively delivered through child health clinics and that community demand for the vaccine is strong. More than 800,000 children have already received the vaccine.
At a press conference alongside Tedros, Matshidiso Moeti, the WHO regional director for Africa, said the recommendation “offers a glimmer of hope for the continent.”
It will be up to member countries to carry it out.
Clinical trials of RTS,S suggested where used, the vaccine reduces the risk of admission to hospital for severe malaria — a development that carries a high risk of death — by 30%. The pilot program confirmed that effectiveness in the field, said Pedro Alonso, director of WHO’s Global Malaria Program.
Development of the vaccine took 30 years of work involving GSK and a network of African research centers with support from the Seattle-based nongovernmental global health agency PATH, as well as funding for late-stage development of the vaccine from the Bill and Melinda Gates Foundation.
“It has been a long road, and is extremely exciting to finally be able to say that RTS,S could soon be available – alongside other malaria interventions – to more children across Africa,” Ashley Birkett, head of malaria vaccine development for PATH, told STAT via email.