24 July 2015
Gavi, the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria today welcomed news that the European Medicines Agency has offered a positive scientific opinion on malaria candidate vaccine RTS,S.
The decision marks a further significant step towards the availability of a malaria vaccine. Gavi and the Global Fund will now await recommendations from the World Health Organization's Strategic Advisory Group of Experts and the Malaria Policy Advisory Committee before deciding if and how to best support the use of the vaccine.
"There is still a long way to go but it is important not to underestimate the significance of today's decision," said Gavi CEO Dr Seth Berkley. "For the first time a regulator has expressed positive scientific opinion on a vaccine against a parasite. Today marks a step forward for RTS,S but also for all potential vaccines against parasites."
"We are cautiously optimistic about this vaccine candidate, and note today's opinion from the European Medicines Agency with interest," said Dr. Mark Dybul, Executive Director of the Global Fund. "Malaria continues to impose a heavy burden in some of the world's most difficult corners. It could be enormously beneficial to have another tool to fight the disease."
Tremendous progress has been made against malaria. The Millennium Development Goal of reversing the rate of malaria has been met and the rate of incidence is declining worldwide. In 55 countries, there has been a 75 per cent reduction in deaths. Globally, the number of deaths fell from over 1 million in 200o to 584,000 in 2013.
Phase III trial results released in April 2015 suggested RTS,S malaria vaccine could eventually have a role alongside mosquito nets, indoor spraying, prompt diagnostic testing, effective anti-malarial medicines and other tools in further reducing the disease's impact among children in sub-Saharan Africa. The phase III 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.
This means that in places with high malaria burden, the vaccine averted several episodes of malaria per child per year. 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.
Gavi and the Global Fund are continuing to work 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 in conjunction with other proven malaria interventions, as part of an integrated approach towards malaria control. Both organisations are working in close coordination with the Global Malaria Programme at the WHO, other technical and donor partners and implementing countries.