GSK and PATH welcome commitment by Gavi, the Vaccine Alliance, to co-fund pilot implementation programme for RTS,S malaria vaccine candidate in Africa

June 23, 2016 by PATH

UNITAID funding decision expected later this summer

Sally Ethelston: Mobile: +1 202-468-9858

GSK and PATH welcome the commitment by the Board of Gavi, the Vaccine Alliance, to provide up to US$ 27.5 million in co-funding to the World Health Organization (WHO) for a pilot implementation programme for the RTS,S malaria vaccine candidate in sub-Saharan Africa.

This commitment comes as UNITAID's Executive Board today indicated that providing funding towards the pilot implementation programme aligns with UNITAID's mandate, but that any funding should be limited and proportionate. This statement paves the way for a funding decision later this summer.

Together, the Gavi and UNITAID announcements represent another critical step towards helping the world's first malaria vaccine reach young children in Africa. PATH and GSK remain committed to working in partnership with the WHO, Gavi, UNITAID, and other stakeholders to ensure successful implementation of the pilot programme.

In support of the programme, GSK and PATH will collaborate to donate doses of RTS,S for use in the WHO pilots.

Luc Debruyne, President, Vaccines at GSK said: "Gavi's commitment is a critical milestone in preparation for the pilot programme and in the 30-year effort to bring a malaria vaccine to the children who need it most. We believe that the potential of this vaccine to reduce the burden of disease in sub-Saharan Africa is significant and we welcome the support for the pilot programme to enable us to gain additional information about how best to deliver RTS,S in a real-world setting."

David C. Kaslow, MD, head of PATH's Center for Vaccine Innovation and Access and vice president for product development at PATH, said, "The results of Phase 3 studies demonstrated the potential public health impact of RTS,S, when used alongside bed nets and other malaria control interventions, in the setting of clinical trials. Our goal is to work urgently with WHO, GSK, and other partners to further evaluate the full public health impact of RTS,S–as well as aspects of both implementation feasibility and safety–when provided in a routine use setting. Although Gavi's support comes with contingencies–including that other organizations match its commitment–we are closer to our goal of understanding the full public health value of RTS,S to young children in Africa."

WHO will provide an estimated US$ 17 million in in-kind contributions and PATH, a grantee of the Bill & Melinda Gates Foundation, will receive a grant of approximately US$ 8 million towards the project. The funds committed by Gavi are for the first phase of the pilot programme and contingent upon WHO securing funding from other sources to fill the remaining gap. The pilot programme will be complementary to the follow-up Phase IV clinical studies; GSK is investing more than US$ 200 million in those studies and other remaining development costs.

Thirty-year journey to date

Global efforts have led to a 60 percent reduction in malaria deaths between 2000 and 2015, yet approximately 438,000 people died of the disease in 2015, the vast majority of them young children in Africa. Although existing interventions have helped to reduce malaria deaths significantly since 2000, a well-tolerated and effective vaccine with an acceptable safety profile could add an important complementary tool to existing interventions for malaria control efforts.

RTS,S is the first malaria vaccine candidate to receive a positive scientific opinion from the European Medicines Agency (EMA). According to the EMA, RTS,S "could potentially save lives in the age group most at risk from malaria." This was followed in January 2016 by a position paper from the World Health Organization (WHO) that recommended pilot implementations of RTS,S in settings of moderate-to-high parasite transmission in Africa. Development of RTS,S has been led by GSK for more than 30 years. GSK and PATH's Malaria Vaccine Initiative began their collaboration in 2001.

If full funding for the first phase of the pilot programme is secured by WHO, preparations could begin in several locations in African malaria-endemic countries and the first children could potentially be vaccinated in early 2018.

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