The World Health Organization on Wednesday did recommend the widespread rollout of the first RTS,S/AS01 (RTS,S)malaria vaccine, in a move experts hope could save tens of thousands of children’s lives each year across Africa.
According to WHO, Malaria kills about half a million people each year, nearly all of them in sub-Saharan Africa — including 260,000 children under five years. The new vaccine, made by GlaxoSmithKline, rouses a child’s immune system to thwart Plasmodium falciparum, the deadliest of five malaria pathogens and the most prevalent in Africa.
This is not only the first authorized malaria vaccine, it’s also the first vaccine ever approved for use against a parasitic disease in humans.
Hailing “an historic day”, the WHO’s director general, Dr Tedros Adhanom Ghebreyesus, said that after a successful pilot programme in three African countries the RTS,S, sold as “Mosquirix” should be made available more widely.
“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. And today is that day, an historic day. Today, the WHO is recommending the broad use of the world’s first malaria vaccine,” Tedros said at a press conference in Geneva, reports The Guardian.
Since 2019, 2.3 million doses of Mosquirix have been administered to infants in Ghana, Kenya and Malawi in a large-scale pilot programme coordinated by the WHO.
In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly parasitic disease. Parasites are much more complex than viruses or bacteria.
“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”
A recent trial of the vaccine in combination with preventive drugs given to children during high-transmission seasons found that the dual approach was much more effective at preventing severe disease, hospitalization and death than either method alone.
“Using this vaccine in addition to existing tools to prevent malaria could save tens of thousands of young lives each year,” said Tedros on Wednesday. “It is safe. It significantly reduces life-threatening, severe malaria, and we estimate it to be highly cost-effective.”
He added: “Malaria has been with us for millennia, and the dream of a malaria vaccine has been a long-held, but unattainable dream. Today, the RTS,S malaria vaccine, more than 30 years in the making, changes the course of public health history. We still have a very long road to travel. But this is a long stride down that road.”
The deadly disease killed 386,000 Africans in 2019, according to a WHO estimate, compared with 212,000 confirmed deaths from COVID-19 in the past 18 months.
But experts hope the WHO’s announcement will re-energise the race to find other vaccines to aid the fight against the disease.
The vaccine, which went through lengthy clinical trials, has limited efficacy of about 30 percent in preventing severe malaria cases and 39% of malaria cases among small children in Africa over four years of trials, but it is the only approved vaccine. The European Union’s drugs regulator approved it in 2015, saying its benefits outweighed the risks.
Pedro Alonso, head of WHO’s Global Malaria Program, says part of the problem is that malaria is a complicated disease. “This is a parasitic disease,” he points out. The parasite life cycle plays out in multiple stages in different parts of the human body and in the mosquito hosts. “This is orders of magnitude more complex in terms of the biology of the causative organism [than a virus],” he says.
Alonso would love to see a vaccine that’s 95% effective in preventing malaria but says the scientific community is still a long way off from developing that: “But what we do have right now is a vaccine that can be deployed, that is accepted, that is safe and that can have a massive impact in terms of lives saved and episodes of malaria averted.”
Another vaccine against malaria, developed by scientists at the UK’s University of Oxford and called R21/Matrix-M, showed up to 77 percent efficacy in a year-long study involving 450 children in Burkina Faso, researchers said in April, but it is still in the trial stages.
Thomas Breuer, GlaxoSmithKline’s chief global health officer, said: “GSK is proud that RTS,S, our groundbreaking malaria vaccine, developed over decades by our teams and partners, can now be made available to children across sub-Saharan Africa.
“This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled. Both real-world evidence and clinical trial data show that RTS,S, alongside other malaria prevention measures, has the potential to save hundreds of thousands of lives.”
GlaxoSmithKline had donated 10 million doses of the vaccine for pilot programs and has now pledged to deliver 15 million doses a year at a price of 5% above cost. However, it’s still unclear who’ll fund the production and distribution of the vaccine to some of the world’s poorest countries.