Added to existing commitments from Gavi and UNITAID, WHO has the funding required to allow pilot implementation to move ahead in sub-Saharan Africa
PATH and GSK welcome the decision by the Board of The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide US$15 million in funding for pilot implementation of the RTS,S/AS01 malaria vaccine candidate in sub-Saharan Africa. In January this year, the World Health Organization (WHO) recommended that the RTS,S vaccine be further evaluated in three to five locations, to address several knowledge gaps, before considering wider-scale introduction.
With the new commitment from The Global Fund, and previously secured funding from UNITAID (up to $13.2 million) and Gavi, the Vaccine Alliance (up to $27.5 million), WHO has the funds needed for the pilot implementation of RTS,S to move forward. The pilots will evaluate the vaccine in real-life settings in sub-Saharan Africa and will be coordinated by WHO.
Support for the pilot implementation will also come from WHO, which previously committed an estimated $17 million of contributions "in-kind."
PATH and GSK remain committed to working with WHO, Gavi, UNITAID, The Global Fund, and other stakeholders to ensure successful implementation of the pilot programme. GSK and PATH will collaborate to donate doses of RTS,S for use in the WHO pilots.
With this new commitment of financial resources, RTS,S—the only malaria vaccine candidate to receive a positive scientific opinion by a stringent regulatory authority and a WHO recommendation—has passed another milestone. "In areas of Africa where the burden of malaria still remains intolerably high, a malaria vaccine could have a significant impact on illness and death," said David C. Kaslow, MD, Vice President of Essential Medicines at PATH and head of PATH's Center for Vaccine Innovation and Access. "Working in partnership with WHO and GSK, we are keen to gather the urgently needed evidence that authorities and, eventually, individual African countries require to decide whether or not the vaccine should be routinely used on a larger scale in Africa."
Sophie Biernaux, Vice President, Head of Diseases of Developing World Programmes, GSK said: "Today's commitment from The Global Fund is an important moment in the 30-year effort to bring a malaria vaccine to the children who need it most. Together with the generous funding commitments from Gavi and UNITAID, this means the pilot implementation of RTS,S in sub-Saharan Africa can move ahead to enable us to gain additional information about how best to deliver RTS,S in a real-world setting."
Next steps in the process will include an announcement from WHO to confirm which countries agree to partner in pilot implementation of the vaccine candidate. PATH and GSK stand ready to work with WHO as it plans the next steps toward pilot implementation of RTS,S.
First conceived in the 1980s, the RTS,S candidate malaria vaccine has undergone a series of studies, including a Phase 3 clinical trial which involved over 15,000 infants and young children and 11 sites in seven African countries and concluded in early 2014. Since then, the candidate vaccine's data have been reviewed by two leading health authorities. First, RTS,S received a positive scientific opinion from Europe's regulatory health authority, the European Medicines Agency, in July 2015. Then, after a consultation process, WHO issued its position on taking this candidate vaccine forward.
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 bed nets and appropriate case management. Despite progress made in disease control measures, malaria remains a leading cause of death in children in sub-Saharan Africa. According to WHO, there were 214 million new malaria cases and 438,000 malaria deaths in 2015, with Africa bearing the greatest burden of both.
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PATH is the leader in global health innovation. An international nonprofit organization, we save lives and improve health, especially among women and children. We accelerate innovation across five platforms— vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health. Learn more at www.path.org.
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. Learn more at www.malariavaccine.org or http://sites.path.org/cvia/.
Posted November 17, 2016.