First-ever malaria vaccine to get WHO recommendation for roll-out

GSK’s RTS,S vaccine is an important complement to existing malaria interventions.

07 Oct 2021

MMV welcomes news from the WHO that GSK’s RTS,S malaria vaccine (MosquirixTM) is now recommended for deployment in African infants. This represents the first malaria vaccine, and first vaccine against a human parasite, to be approved and rolled-out.

This landmark recommendation is based on the results of a WHO-coordinated pilot programme in Ghana, Kenya and Malawi, where the vaccine has been deployed since 2019, with funding from Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.

With support from Ministries of Health in these three countries as well as a range of in-country and international partners, more than 800,000 children have received at least one dose of RTS,S, and 2.3 million doses have been administered through routine immunization programmes.

The pilot programme gauged the feasibility of delivering the 4-dose regimen of the vaccine to children, the complexity of which had initially raised concerns. It also studied the vaccine’s role in reducing childhood deaths and its safety profile in the context of routine use. Data reveal that RTS,S has a favorable safety profile and when deployed alongside standard malaria protection measures can significantly reduce the development of severe, life-threatening malaria, and can be delivered effectively in real-life settings.

It’s important to note that the RTS,S vaccine does not offer full protection against malaria — clinical trials suggested that it reduces the risk of contracting malaria by 40% and the risk of hospital admission with severe malaria by around 30% when at least three -doses are administered. These results have been confirmed by the pilot programme.

Although its effectiveness does not match those of vaccines against other childhood diseases such as measles or rubella — the use of RTS,S is expected to help reduce the burden of malaria on children in endemic countries where this vulnerable group can contract the disease many times a year. Recently published data from the London School of Tropical Medicine and Hygiene showed that the reduction in malaria is greatesteven greater when used in conjunction with standard malaria control measures including bed nets, indoor residual spraying and medicines for seasonal malaria chemoprevention.

“This is a historic moment for malaria research,” said Dr David Reddy, CEO of MMV. “We, at MMV, have been following the progress of GSK’s RTS,S since the final results of its Phase III programme were published in 2015 and are delighted to hear of WHO’s endorsement of this important tool in the fight against malaria. This highlights the long-term commitment of GSK as a leader in using innovative technologies to support the drive to eradicate malaria. Its addition to the malaria toolbox will help the global health community to accelerate towards the malaria elimination goals and save thousands of young lives. At the same time, we acknowledge that this is not a silver bullet solution and we must continue to develop new more effective therapies, vaccines and preventive tools against malaria. There is no time to lose – the deadline for attainment of the malaria goals of 2030 is just 9 years away.”

The vaccine development has taken over 30 years of refinement and optimisation and is the result of an international collaboration between the British pharmaceutical company GSK, a network of African research centres, PATH, MVI and funding for late-stage development from the BMGF.