New phase 3 study results of the RTS,S/AS01 malaria vaccine

Statement by WHO Regional Director for Africa, Dr Matshidiso Moeti

In the African Region, even as countries grapple with the once-in-a-generation COVID-19 pandemic, they are responding to a multitude of other health threats. Children in many parts of the continent remain at high risk of dying from malaria. 

After decades of gains, progress against malaria has plateaued – 265,000 African children died of this diseasein 2019. We must do more to get malaria control back on track.

Today’s striking new evidence should strengthen the fight against malaria: a study published in the New England Journal of Medicine describes a novel and strategic way to use the RTS,S malaria vaccine – before the peak malaria seasons in areas of highly seasonal malariatransmission.  This could have a remarkable impact in reducing deaths among African children.

The phase 3 trial results in Burkina Faso and Mali showthat using the RTS,S vaccine plus antimalarial drugs before the rainy season starts, results in a 70% reduction in malaria hospitalizations and deaths in children.

In addition, the RTS,S vaccine used as a seasonal vaccine can reduce malaria cases by about 75%. This is the same efficacy as antimalarial drugs alone given during the rainy season. This is the highest efficacy of any malaria vaccine to be shown in a large phase 3 clinical trial.

More than 30 million young children living in areas of highly seasonal malaria transmission could benefit from the strategic use of the RTS,S vaccine.

We already knew that this vaccine reduces malaria cases and severity where the disease occurs year-round. This new research further demonstrates the vaccine’s effectiveness and potential to have a life-saving impact in Africa in areas with highly seasonal malaria outbreaks.

This same vaccine is now being piloted in Ghana, Kenya and Malawi, through the Malaria Vaccine Implementation Programme, supported by WHO. More than 2.1 million doses have been provided through the routine childhood immunization programmes, and more than 740 000 children have benefited from the additional protection against malaria. The level of vaccine uptake by families over a relatively short period indicates strong community demand for the vaccine and the capacity of childhood vaccination programmes to deliver it.

As we consider the future of this vaccine, and how and where it may be used, these results reaffirm the power of science to push through barriers, with creativity and novel approaches, to save lives. 

Access the study here: DOI: 10.1056/NEJMoa20263302