PATH welcomes remarkable results from clinical trial combining RTS,S/AS01 malaria vaccine with Seasonal Malaria Chemoprevention

Media contact: Lindsay Bosslet | PATH | media@path.org

Seattle, WA, August 25, 2021 — Today, the results of a three-year Phase 3 malaria vaccine study conducted in Burkina Faso and Mali by the London School of Hygiene and Tropical Medicine (LSHTM), Institut de Recherche en Sciences de la Santé, and the Malaria Research and Training Centre, University of Bamako, were published in the New England Journal of Medicine. The study found that not only was the impact of seasonal vaccination with RTS,S/AS01E (RTS,S) comparable to that of seasonal malaria chemoprevention (SMC), but that combining the two interventions reduced malaria episodes and deaths in children by about 70 percent compared to either intervention alone.

“This represents a potential breakthrough for how the world’s first malaria vaccine could be used in a new way to save children’s lives,” said Dr. Ashley Birkett, director of PATH’s Malaria Vaccine Initiative (PATH), which provided partial funding for year three of the study. “The evidence from Burkina Faso and Mali suggests that in areas with highly seasonal malaria, using the RTS,S vaccine just prior to the peak transmission season in combination with current malaria control interventions, could have a major impact.”

Currently, the RTS,S malaria vaccine is being introduced in a landmark pilot programme to help protect children from malaria in areas of three countries that experience malaria infections year-round—Ghana, Kenya, and Malawi. The study from the LSHTM and partners reaffirms the safety and efficacy of the vaccine and helps build a case for use of the vaccine as an option in places with highly seasonal malaria, where SMC alone is the current standard approach to preventing the disease in children under the age of five.

This study, which PATH is supporting for an additional two years to follow participants through the age of five, was conducted in areas of Burkina Faso and Mali where there is high use of insecticide-treated bed nets and SMC. Despite this, the malaria burden remains extremely high in these areas, which is a clear indication that additional tools are needed.

“These results are really remarkable and illustrate the importance of continuing to explore ways to optimize the use of vaccines even after they’re developed,” says Dr. Birkett. “This potential new use could help countries more effectively prevent malaria and save more young lives.”

World Health Organization (WHO) global advisory bodies for immunization and malaria will convene in October for a full review of RTS,S evidence generated by the pilot evaluation of the malaria vaccine in routine use (in Ghana, Kenya and Malawi) and other RTS,S data that have become available since the pilots were recommended by WHO in 2015. The review will include results from this Phase 3 trial on RTS,S seasonal vaccination. All of these data will inform a potential WHO recommendation for wider use of the vaccine in sub-Saharan Africa.

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Background on the RTS,S/AS01E Malaria Vaccine Implementation Programme (MVIP)

The RTS,S malaria vaccine is the first to reach children in childhood vaccination through a landmark pilot programme in areas of Ghana, Kenya, and Malawi, under the Malaria Vaccine Implementation Programme (MVIP). The WHO-coordinated MVIP is a collaborative effort with the three ministries of health and a range of in-country and international partners, including PATH, a global non-profit organization, and GSK, the vaccine developer and manufacturer.

Ministries of health are introducing the vaccine through the three countries’ routine immunization programmes, with WHO playing a coordinating role and working in collaboration with PATH and GSK, and other partners.

RTS,S is the first malaria vaccine to have received a positive scientific opinion from the European Medicines Agency and approval for use in the pilots by the regulatory authorities of Ghana, Kenya, and Malawi. RTS,S was developed by GSK over more than 30 years and in partnership with PATH since 2001. At the same time, PATH continues efforts to accelerate development of next-generation vaccines and biologics, working with a wide range of academic, business, and governmental organizations, and also continues to support research on the optimal use of RTS,S.

Since the pilot introduction was initiated in 2019 more than 2.1 million doses of vaccine have been administered and more than 740,000 children reached with at least one dose of the vaccine. Vaccine uptake has been strong in communities, health worker acceptance is high, and the pilot implementation has continued with minimal disruptions despite COVID-19.

About PATH

PATH is a global nonprofit dedicated to ending health inequity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing public health challenges. Learn more at www.path.org. Learn more about PATH’s malaria vaccine efforts at www.malariavaccine.org.