Geneva – Malaria vaccine pilots will be a crucial test for a potentially valuable new tool in the fight against the disease, the three agencies funding the vaccine pilots said following the launch of the first in Malawi.
The pilots, which will also launch soon in Kenya and Ghana, will aim to vaccinate around 360,000 children per year in the three countries to evaluate the feasibility of delivering the required four doses of RTS,S in real-life settings, the vaccine’s potential role in reducing childhood deaths and its safety in the context of routine use.
Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria and Unitaid are together providing just under US$ 50 million to fund the first phase of the pilots. Ministries of Health in Ghana, Kenya and Malawi will implement the pilots, in coordination with WHO.
“Malaria is still one of the biggest killers of children worldwide, taking the lives of over 200,000 children every year,” said Dr Seth Berkley, CEO of Gavi. “These pilots will be crucial to determine the part this vaccine could play in reducing the burden this disease continues to place on the world’s poorest countries.”
“To step up the fight against malaria, we need every available tool,” said Peter Sands, Executive Director of the Global Fund. “If this pilot shows that RTS,S is a cost-effective tool against malaria, it will help us save more children’s lives.”
“The malaria vaccine is an exciting innovation that complements the global health community’s efforts to end the malaria epidemic,” said Lelio Marmora, Executive Director of Unitaid. “It is also a shining example of the kind of inter-agency coordination that we need. We look forward to learning how the vaccine can be integrated for greatest impact into our work.”
In clinical trials the vaccine was found to prevent approximately 4 in 10 malaria cases, as well as 3 in 10 cases of life-threatening severe malaria. It also reduced severe malaria anaemia, the most common reason children die from the disease, by 60%.
A 4-dose schedule is required, with the first dose given as soon as possible after five months of age, doses two and three given at monthly intervals after that, and the fourth dose given 15–18 months after the third dose. The vaccine will not be available in all regions of the countries, nor will it be given to adults or children outside the target age group.
In the Phase 3 trial the vaccine was generally well tolerated, with adverse reactions comparable to those of other childhood vaccines. The European Medicines Agency (EMA) carried out a scientific assessment of RTS,S and concluded that the vaccine has an acceptable safety profile in a scientific opinion issued in July 2015.
The vaccine is being considered as a complementary malaria control tool to be added to the core package of WHO-recommended measures for malaria prevention. This includes the routine use of insecticide-treated bednets, indoor spraying with insecticides and the timely use of malaria testing and treatment.
