The British drugmaker which made the first malaria vaccine expects a mass roll-out of the jab in African countries by the end of 2022.
GSK called the World Health Organisation’s approval of the vaccine a “landmark step” on the road to inoculating populations against the disease which kills 500,000 people a year, half of them African children.
Experts on the WHO's advisory bodies for immunisation and malaria said the RTS,S vaccine — or Mosquirix — could save tens of thousands of lives each year.
Following the approval by the UN body, Thomas Breuer, chief global health officer at GSK, said the next step would be for the international community to agree on a way to fund the procurement of enough vaccines.
“If this goes through, I can see the vaccine for broader use in Sub-Saharan Africa at the end of 2022, beginning of 2023,” he told BBC Radio 4’s Today programme.
The pharma giant has already made 2.5 million doses of the vaccine, which were used in pilot schemes in Kenya, Malawi and Ghana.
The vaccine requires four doses to be given to children aged five months and older.
The WHO said it provides a 30 per cent reduction in deadly severe malaria.
Mr Breuer said GSK had already committed to making 15 million doses a year, but it is up to world powers to decide whether that will be enough to vaccinate children in regions with moderate to high levels of malaria.
“We have initially already committed to provide 15 million doses per year. Whether that will be enough, again, this is not up to GSK,” he said.
“WHO and other agencies have to decide how they want to use the vaccine.
“But from a pricing point of view, GSK has really gone all the way by not trying to recuperate the development costs, which currently amount up to $700 million. We will not do that, but we will make the vaccine available at the cost of goods, so at the cost of manufacturing.”
More than 260,000 African children die from malaria every year. WHO said the decision to approve the vaccine “changes the course of public health history”.
Following trials, WHO said the vaccine has a strong safety profile, is deliverable, and could save tens of thousands of lives a year.
WHO's director general Dr Tedros Adhanom Ghebreyesus hailed the approval as a “historic moment” and a “breakthrough for science, child health and malaria control.”
Speaking on Wednesday following the announcement, Dr Matshidiso Moeti, WHO’s regional director for Africa, said the news would give hope to people in countries badly hit by malaria.
“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,” he said.
“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 to grow into healthy adults.”
Prof Sir Brian Greenwood, from the London School of Hygiene and Tropical Medicine, has played a pivotal role in malaria vaccination trials and research since the inception of the vaccine.
“With malaria still a major cause of death, especially among children in Africa, this decision has the potential to save millions of young lives,” he 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.”