Today is World Malaria Day. While this day is typically disregarded by the public at large, it bears great significance on the continent. Today, according to the World Health Organziation (WHO) Africa bears the greatest brunt of malaria across the globe, with 429 000 people dying of the disease in 2015, although there has been a 62% reduction in malaria deaths over the past 15 years.
In an effort to accelerate the process of bringing Malaria to a zero infectious rate, Ghana, Kenya and Malawi have adopted the WHO Malaria vaccine pilot program. This was announced yesterday by WHO Reigonal Director for Africa Dr Matshidiso Moeti. The Malaria vaccine implementation programme (MVIP) is the world’s first malaria vaccine that will be dispensed next year.
The injectable vaccine was developed to protect young children from the deadliest form of malaria caused by Plasmodium falciparum. The vaccination, RTS S is set out to be assessed in the pilot programme as a complimentary malaria control tool that could be included with the core package of WHO recommended measures for malaria prevention.
“The prospect of a malaria vaccine is great news. Information gathered in the pilot programme will help us make decisions on the wider use of this vaccine, said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Combined with existing malaria interventions, such a vaccine would have the potential to save tens of thousands of lives in Africa,” she added.
ABOUT RTS DEVELOPMENT
RTS,S was developed by GSK and is the first malaria vaccine to have successfully completed a Phase 3 clinical trial. The trial was 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 is also the first malaria vaccine to have obtained a positive scientific opinion from a stringent medicines regulatory authority, the European Medicines Agency (EMA). The opinion indicated that, in EMA’s assessment, the quality of the vaccine and its risk-benefit profile was favorable from a regulatory perspective.
In October 2015, two independent WHO advisory groups, comprised of the world’s foremost experts on vaccines and malaria, recommended pilot implementation of RTS,S in three to five settings in sub-Saharan Africa. The recommendation came from the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), following a joint review of all available evidence on the vaccine’s safety and efficacy. WHO formally adopted the recommendation in January 2016.
SELECTION OF COUNTRIES
The three countries were selected to participate in the pilot programme based on the following criteria: high coverage of long-lasting insecticidal nets (LLINs); well-functioning malaria and immunisation programmes, a high malaria burden even after scale-up of LLINs, and participation in the Phase 3 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 prioritized, 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 immunization programmes. WHO is working with the three countries to facilitate regulatory authorization 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
