Gavi and the Global Fund welcome malaria vaccine trial results

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Latest data published by Glaxosmithkline and PATH Malaria Vaccine initiative includes booster dose results

Geneva, 24 April 2015 - Gavi, the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria welcome the results of a large-scale trial of a malaria vaccine candidate in sub-Saharan Africa.

The results suggest a malaria vaccine could eventually have a role alongside mosquito nets, indoor spraying, prompt diagnostic testing, effective anti-malarial medicines and other tools in reducing the disease’s impact among children in sub-Saharan Africa.

The phase three trial of the RTS,S malaria vaccine candidate showed a 54 percent reduction in cases of clinical malaria over the first year of follow-up and a 36 percent reduction in clinical malaria over a 48 month period among children vaccinated between 5-17 months old who received four doses of the vaccine. On average across the trial sites, more than 1,700 cases of clinical malaria were averted per 1,000 children vaccinated.

For infants who were vaccinated aged 6-12 weeks, the reduction in clinical malaria was 26 percent over a follow up period of 38 months.

The five year trial concluded in January and involved 15,459 children and infants.

The trial was conducted across eleven research centres in seven African countries in partnership with GSK and the PATH Malaria Vaccine Initiative.

Responding to the new results, Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, said: “Given the huge disease burden of malaria in developing countries, particularly in sub-Saharan Africa where it kills hundreds of thousands of children every year, today’s results will be of enormous interest to everyone aiming to improve the health of the world’s poorest people.”

Dr. Mark Dybul, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, added: “These results are very encouraging and suggest that a vaccine may eventually be an excellent addition to our current tools of mosquito nets and indoor spraying.”

The vaccine is currently being reviewed by the European Medicines Agency (EMA), with the Agency expected to provide a scientific opinion later in the year, which could expedite licensure in African countries. If the EMA’s opinion is positive, the World Health Organization’s Strategic Advisory Group of Experts and the Malaria Policy Advisory Committee will make recommendations regarding the vaccine’s use.

Gavi and the Global Fund are committed to working together to plan for the possible use of a malaria vaccine, if recommended by WHO and if the Gavi and Global Fund boards decide to support the vaccine, as part of an integrated approach towards malaria control. Both organisations will continue to work in close coordination with the Global Malaria Programme at the World Health Organization, other technical partners and implementing countries.

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