Gavi Board makes decisions on malaria vaccine pilots, health systems, and supply and procurement strategy vaccine pilot commitment:

At her first Board meeting, Dr. Ngozi Okonjo-Iweala calls on funders to match Gavi’s proposed malaria vaccine pilot commitment

Geneva, 23 June 2016 – 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.”

“The evidence we have so far suggests a malaria vaccine could have a significant impact in reducing malaria mortality in Africa,” said Dr Seth Berkley, Gavi CEO. “RTS,S demonstrated 39% efficacy against clinical malaria in phase III trials but measuring the vaccine’s impact in real life settings is what will ultimately help the health community assess the value of this vaccine in the fight against malaria along with other existing interventions.”

“For decades, a malaria vaccine has been one of the holy grails of modern medicine,” said Dr Pedro Alonso, Director of the WHO Global Malaria Programme. “Gavi’s pledge will help us fund the pilot deployment of a first-generation malaria vaccine that has the potential to save tens of thousands of lives in Africa.”

The RTS,S malaria vaccine received a positive scientific opinion from the European Medicines Agency in 2015 and WHO prequalification of the vaccine is expected before the start of the pilots. RTS,S prevented 39% of malaria cases in children vaccinated with four doses during trials in Africa, when added to existing malaria control and prevention tools. Models predict that the vaccine could be highly impactful, saving one life for every 200 children vaccinated.

The Board underlined the importance of a collaborative approach to the pilots and the need for other funders to come forward to fill the remaining funding requirements. The Board also stressed that today’s decision should not be considered as an indication of future Gavi funding for malaria vaccine, or for future similar pilot schemes for other vaccines, and the importance of regular reporting as the trials progress.

Today’s decision relates to the first phase of the pilot, running from 2017 to 2020. Any funding request for phase two of the pilots would require Gavi Board approval. If the two-phase pilot is successful and full-scale implementation is recommended by WHO, a new investment case would be put before the Gavi Board for a decision on whether to finance the broader rollout of the vaccine in Africa.
Vaccine Alliance 2016-2020 strategy implementation

The Gavi Board also approved two critical elements of Gavi’s approach towards delivering on the Vaccine Alliance’s 2016 to 2020 strategy.

The first, the Supply and Procurement Strategy, will help foster healthy markets for vaccines and other immunisation-related products that will benefit Gavi-supported countries and those who transition from Gavi support. Building on Gavi’s experience and success over the past 15 years, including a 43% reduction in the cost of a fully immunising a child with pentavalent, pneumococcal and rotavirus vaccines during the 2011 to 2015 Gavi strategic period, the strategy takes a long-term approach towards shaping markets, drawing on the expertise of a more diverse group of partners and engaging with an expanded group of manufacturers.

The Supply and Procurement Strategy also explicitly defines a greater role for Gavi in product innovation. By convening and coordinating partners including manufacturers, product development partnerships, and technical experts, Gavi will create a platform to share and meet country needs, set innovation priorities, and inform manufacturers’ investment decisions.

Secondly, the Board approved a new framework for Gavi’s financial support for countries. The Health System and Immunisation Strengthening Support framework will ensure that Gavi’s investments are more aligned and targeted to help countries reach children who are currently missing out on essential vaccines. Gavi’s HSIS support is part of the Vaccine Alliance’s commitment to universal Health Coverage and the Sustainable Development Goals.

The new framework also better aligns Gavi support with national plans and introduces greater flexibility to enable countries to adjust their programmes in response to new evidence. This is coupled with integrated planning and budgeting for all financial support, to increase efficiency and reduce transaction costs for countries.

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