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 vaccine 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.
The RTS,S vaccine, also known as Mosquirix, was developed by the British pharmaceutical company GlaxoSmithKline (GSK), and has been administered to more than 800,000 children in Ghana, Kenya and Malawi since the pilot programme began in 2019.
The vaccine, which went through lengthy clinical trials, has limited efficacy, preventing 39% of malaria cases and 29% of severe malaria cases among small children in Africa over four years of trials.
However, in August a study led by the London School of Hygiene & Tropical Medicine (LSHTM) found that when young children were given both the RTS,S and antimalarial drugs there was a 70% reduction in hospitalisation or death.
“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.”
There have been fears that decades of progress towards ending malaria has stalled, with some countries, such as Eritrea and Sudan, seeing significant resurgences in recent years. In 2019, 409,000 people died from the mosquito-borne parasite disease, most of them in Africa. More than 270,000 of the victims were children under five.
But experts hope the WHO’s announcement will re-energise the race to find other vaccines, a quest that has been going on for almost a century.
Earlier this year, scientists at the Jenner Institute of Oxford University said a vaccine they had developed had shown results that would make it the first to meet the WHO goal of 75% efficacy. Over 12 months the vaccine showed up to 77% efficacy in a trial of 450 children in Burkina Faso. Larger trials are now beginning, involving 4,800 children in four countries.
Thomas Breuer, GSK’s chief global health officer, said: “GSK is proud that RTS,S, our ground breaking 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.”
GSK said it was committed to supplying up to 15m doses a year at no more than 5% above the cost of production, and would now work with partners, funders and governments to support additional supply of the vaccine.
Professor Sir Brian Greenwood from the LSHTM said: “The RTS,S vaccine does not provide complete protection but this decision is testament to the global health community’s drive and vision to find a way forward. As part of a tailored approach it has great potential to reduce death and illness in high burden areas, especially when combined with other interventions such as seasonal malaria chemoprevention and bed nets, and be a huge boost to malaria control efforts.”
Gareth Jenkins, director of advocacy at the charity Malaria No More, said the announcement was “a truly historic moment” and “another critical step in building our armoury of weapons” against malaria.
Noting the role played by GSK in the development of the RTS,S vaccine, he called on the UK government to continue to invest in cutting-edge research that could “finally bring about a zero-malaria world”.
“This complex, but preventable and treatable disease, causes hundreds of millions of infections each year, risking lives and livelihoods, trapping people in poverty in some of the poorest countries in Africa, and creating ‘disease blind spots’ which threaten our own health security at home. If we save lives from malaria today, we can also protect ourselves against the diseases of tomorrow,” he said.
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