PATH and GSK welcome progress toward RTS,S malaria vaccine pilot implementation with selection of countries

GSK: Catherine Hartley | Mobile: +44 (79) 0900 2403 | catherine.a.hartley@gsk.com | London PATH/MVI: Preeti Singh | Mobile: +1 703.862.2515 | psingh@burness.com | Washington/USA

PATH and GSK welcome the World Health Organization's (WHO) announcement of the countries selected to participate in the first pilot implementation of the RTS,S/AS01 malaria vaccine (also known as Mosquirix™). The pilot implementation is due to begin in 2018. The selected countries—Ghana, Kenya, and Malawi—have achieved significant reductions in malaria mortality through the deployment of currently available prevention and control measures, but still face a substantial disease burden from malaria. Each of these countries have experience with RTS,S from the large Phase 3 efficacy and safety trial of the vaccine, which concluded in early 2014.

PATH and GSK are proud to be working with WHO, the ministries of health within Kenya, Ghana, and Malawi, and other stakeholders to ensure successful implementation of the program. GSK and PATH will collaborate to donate doses of RTS,S for use in the pilot implementation.

The pilot implementation will take place on a subnational level within Kenya, Ghana, and Malawi to assess the use of the vaccine, which was positively reviewed by the European Medicines Agency (EMA), in real-life settings. RTS,S will be administrated to approximately half of the more than 750,000 participating children as part of routine medical care. WHO recommended pilot implementation to evaluate the feasibility of delivering the required four doses of RTS,S, the vaccine's potential role in reducing childhood deaths, and its safety in the context of routine use, before considering wider-scale introduction. Pilot implementation will be complemented by the Phase 4 studies led by GSK that are part of the risk management plan agreed upon by GSK and the EMA.

The pilot implementation represents another important step toward making a malaria vaccine more widely available to children most at risk from malaria in sub-Saharan Africa.

First conceived in the 1980s, the RTS,S malaria vaccine candidate has undergone a series of studies, including a Phase 3 efficacy and safety trial that involved over 15,000 infants and young children and 11 sites in seven African countries. This trial concluded in early 2014. Since then, the data generated on the candidate vaccine have been reviewed by two leading health authorities. First, RTS,S received a positive scientific opinion from the EMA, Europe's regulatory authority, in July 2015. Then, after a consultation process, WHO issued its position paper in January 2016, recommending pilot implementation.

RTS,S is designed to help prevent Plasmodium falciparum malaria in sub-Saharan Africa, and is proposed as a tool to complement other malaria control interventions, such as bednets, drugs, and insecticides, as well as appropriate case management. Despite progress made using currently available disease control measures, malaria remains a leading cause of death in children in sub-Saharan Africa. According to WHO, there were 212 million new malaria cases and 429,000 malaria deaths in 2015, with Africa bearing the greatest burden.

PATH's Malaria Vaccine Initiative (MVI) accelerates malaria vaccine development and catalyzes timely access in endemic countries, toward a world free from malaria. Standing at the intersection of malaria and immunization, MVI is part of PATH's Center for Malaria Control and Elimination and PATH's Center for Vaccine Innovation and Access, which brings together PATH's expertise across every stage of vaccine research, development, and introduction to make lifesaving vaccines widely available to women, children, and communities across the world. Learn more at www.malariavaccine.org and http://sites.path.org/cvia.

GSK—one of the world's leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Posted April 24, 2017.