In 2018 Ghana, Kenya and Malawi will take part in a WHO-coordinated pilot programme of the world’s first malaria vaccine.
RTS,S was the first malaria vaccine to have successfully completed a Phase III clinical trial, which conducted between 2009 and 2014 through a partnership involving GSK, the PATH Malaria Vaccine Initiative with support from the Bill & Melinda Gates Foundation, and a network of African research sites in seven African countries—including Ghana, Kenya, and Malawi.
RTS,S will be assessed in the pilot programme as a complementary malaria control tool that could potentially be added to the core package of WHO-recommended measures for malaria prevention.
“The prospect of a malaria vaccine is great news. Information gathered in the pilot will help us make decisions on the wider use of this vaccine”, said WHO Regional Director for Africa, Dr Matshidiso Moeti.
“Combined with existing malaria interventions, such a vaccine would have the potential to save tens of thousands of lives in Africa,” continued Dr Moeti.
Africa bears the greatest burden of malaria worldwide. Global efforts in the last 15 years have led to a 62% reduction in malaria deaths between 2000 and 2015, yet approximately 429,000 people died of the disease in 2015, the majority of them young children in Africa.
The WHO pilot programme will assess whether the vaccine’s protective effect in children aged 5 – 17 months old during Phase III testing can be replicated in real-life. Specifically, the pilot programme will assess the feasibility of delivering the required four doses of RTS,S, the vaccine’s potential role in reducing childhood deaths, and its safety in the context of routine use.
Ghana, Kenya and Malawi were selected to participate in the pilot based on the following criteria: high coverage of long-lasting insecticidal-treated nets (LLINs); well-functioning malaria and immunisation programmes, a high malaria burden even after scale-up of LLINs, and participation in the Phase III RTS,S malaria vaccine trial.
Each of the three countries will decide on the districts and regions to be included in the pilots. High malaria burden areas will be prioritised, as this is where the benefit of the vaccine is predicted to be highest. Information garnered from the pilot will help to inform later decisions about potential wider use of the vaccine.
The malaria vaccine will be administered via intramuscular injection and delivered through the routine national immunisation programmes. WHO is working with the three countries to facilitate regulatory authorisation of the vaccine for use in the pilots through the African Vaccine Regulatory Forum (AVAREF). Regulatory support will also include measures to enable the appropriate safety monitoring of the vaccine and rigorous evaluation for eventual large scale use.
Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID, are partnering to provide US$49.2 million for the first phase of the pilot programme (2017-2020) which will be complemented by in-kind contributions from WHO and GSK.