Gavi [to 25 June 2016]
http://www.gavialliance.org/library/news/press-releases/

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23 June 2016
Gavi Board makes decisions on malaria vaccine pilots, health systems, and supply and procurement strategy
At her first Board meeting, Dr. Ngozi Okonjo-Iweala calls on funders to match Gavi’s proposed malaria vaccine pilot commitment

Geneva – Gavi, the Vaccine Alliance is ready to play a role in supporting WHO’s malaria vaccine pilots. The decision, taken today by the Gavi Board, would see up to US$ 27.5 million of support for the first phase of the pilots, provided other organisations come forward to match the Vaccine Alliance’s commitment.

The pilots will provide real-world insight into how the RTS,S malaria vaccine, developed by GSK, could be implemented in Africa, given that three of the four doses of the vaccine will be given outside the normal schedule for childhood vaccinations. They also will generate further evidence on the vaccine’s potential to reduce the death toll from malaria, which claims almost 440,000 lives every year.

WHO is currently finalising the design of the pilots and will select three African locations to begin implementation, as recommended jointly by the Strategic Advisory Group of Experts on Immunisation (SAGE) and the Malaria Policy Advisory Committee (MPAC).

“Gavi is ready to play its part in helping the world to understand the opportunities and challenges of implementing the world’s first malaria vaccine in real life settings,” said Dr Ngozi Okonjo-Iweala, Chair of the Gavi Board. “Malaria’s heavy burden on Africa means it is vital that we understand the impact of this vaccine in communities, as was so powerfully articulated by the African Ministers of Health represented at the Board. We call on others to come forward with sufficient funding to enable the pilots to proceed.”…

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PATH [to 25 June 2016]
http://www.path.org/news/index.php
Press release | June 23, 2016
GSK and PATH welcome commitment by Gavi, the Vaccine Alliance, to co-fund pilot implementation programme for RTS,S malaria vaccine candidate in Africa
UNITAID funding decision expected later this summer

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..