'An historic day': Malaria vaccine receives WHO seal of approval

The World Health Organization has recommended the broad use of the world’s first malaria vaccine — which has been more than 30 years in the making — for children in sub-Saharan Africa and other at-risk regions. It is also the first vaccine produced for any parasitic disease.

“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,” WHO Director-General Tedros Adhanom Ghebreyesus said during a press briefing Wednesday.

The vaccine “changes the course of public health history,” he added.

The agency now recommends the RTS,S/AS01 malaria vaccine for use in sub-Saharan Africa and other regions that experience significant levels of malaria transmission. More than 260,000 children under 5 years of age die from malaria in Africa each year. And globally, progress in reducing the malaria burden has stalled, Tedros said.

“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Matshidiso Moeti, WHO regional director for Africa, at the press briefing. “We’ve long hoped for an effective malaria vaccine, and now for the first time ever, we have such a vaccine recommended for widespread use.”

This recommendation follows analysis of evidence by two WHO global advisory bodies from an ongoing pilot program in Ghana, Kenya, and Malawi that has vaccinated more than 800,000 children since 2019. The pilot program found that the vaccine is safe, there is community demand for it, and it is a cost-effective prevention method.

This is the largest evaluation of any intervention for malaria and likely one of the largest undertakings for any disease, said Dyann Wirth, chair of the WHO Malaria Policy Advisory Group.

GlaxoSmithKline developed the vaccine with support from the Bill & Melinda Gates Foundation. Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid funded the pilot program. How soon and to what scale countries can begin to roll out the vaccines will remain in question until decisions are made around funding.

WHO’s recommendations include providing four doses to children starting at 5 months of age through about 18 months. The need for the fourth dose is still under evaluation, said Kate O’Brien, director of WHO’s immunization, vaccines, and biologicals department.

Health experts cautioned that this vaccine is not a replacement for other efforts to reduce transmission, including insecticide-treated bed nets.

No vaccines are completely efficacious, and this vaccine is only modestly effective, with trials showing that it is 40% efficacious in reducing cases of clinical malaria and that it reduces severe cases of malaria by 30%, said Mary Hamel, senior technical officer in WHO’s Malaria Vaccines and the Malaria Vaccine Implementation Programme. But because the malaria burden is so high in many African nations, these figures are still expected to make a significant dent in the devastation caused by the disease.

“Children have malaria cases many, many times in a year. And every time that they have a case of malaria, they are at risk of severe malaria and death. At this level of efficacy, the impact could be quite, quite high,” Hamel said.

“That ... is probably one of the most impactful vaccines that one could actually use in Africa right now,” said Pedro Alonso, director of WHO's Global Malaria Programme.

And it will not only prevent deaths, as reducing infection also helps prevent long-term effects on children, such as cognitive impacts, said Alejandro Cravioto, chair of the WHO Strategic Advisory Group of Experts on Immunization.

While researchers would like a vaccine with a higher efficacy rate, the malaria parasite is a “formidable foe,” Wirth said.

 “This is a very complex disease that has evolved mechanisms to evade the normal immune system,” she said.

This is expected to be only the first malaria vaccine, with improved versions in the pipeline, she added.

Following this recommendation from WHO, the African Vaccine Regulatory Forum will support national authorities to fast-track regulatory approvals in countries for introduction, Moeti said.

When the rollout begins will depend on pending decisions around funding, including choices to be made by Gavi's board later this year, O’Brien said. “These questions of exactly how it will be financed, what the cost per dose — these are still issues that are out in front of us,” she said.

“The next few months will be critical in terms of defining the financing mechanisms to ensure that, with the current production capacity, all the children that can benefit do benefit from this vaccine,” Alonso said.

For long-term production, GlaxoSmithKline has a tech transfer agreement with Bharat Biotech in India.