Ghana, Kenya, and Malawi to take part in WHO malaria vaccine pilot programme
The World Health Organization Regional Office for Africa (WHO/AFRO) announced on April 24, 2017, that Ghana, Kenya, and Malawi will partner with WHO in the Malaria Vaccine Implementation Programme (MVIP) that will make the RTS,S vaccine available in selected areas of the three countries. WHO/AFRO announced the countries at a high-level forum in Nairobi, Kenya, organized by WHO and the Ministry of Health of Kenya in advance of World Malaria Day.
The country-led MVIP is being coordinated by WHO, in close collaboration with Ministries of Health in the participating countries and a range of in-country and international partners. Preparations for introduction of the vaccine in parts of Ghana, Kenya, and Malawi are already underway.
In 2020, the implementation program is expected to provide initial insights on the programmatic feasibility of delivering the RTS,S/AS01 vaccine in real-life settings; safety monitoring in the context of routine use will be ongoing throughtout the MVIP. Over time, the program will also generate data on the vaccine’s impact on childhood survival. The results of the MVIP will inform future decisions on the wider-scale deployment of the vaccine.
RTS,S was approved by the national negulatory authorities in each of the three countries participating in the MVIP for use in the context of the pilot evaluation and Phase 4 studies.
Development of RTS.S
RTS,S is the malaria vaccine furthest along in development globally, the outcome of a long-standing collaboration between PATH and GSK that began in 2001. RTS,S is the first and, to date, the only vaccine to show a protective effect against malaria among young children in Phase 3 clinical trials.
RTS,S is an injectable vaccine that provides partial protection against malaria in young children. Like vaccines generally, RTS,S aims to trigger the body’s own immune system to defend against disease, in this case, malaria caused by Plasmodium falciparum, the most deadly species of the malaria parasite globally and the most prevalent in Africa. The large-scale Phase 3 efficacy and safety trial of RTS,S (which concluded in January 2014) showed that the vaccine candidate could provide meaningful public health benefit by reducing the burden of malaria when used alongside currently available interventions such as bednets and insecticides.
Beginning in the 1980s, early development was undertaken by GSK, working in close collaboration with the Walter Reed Army Institute of Research. In January 2001, GSK and PATH’s Malaria Vaccine Initiative (PATH/MVI), with grant money from the Bill & Melinda Gates Foundation to PATH, entered into a public-private partnership to develop the vaccine for infants and young children in sub-Saharan Africa.
Between mid-2009 and early 2014, MVI, GSK, and leading research centers in Africa conducted a Phase 3 efficacy and safety trial of RTS,S that involved 15,459 infants and young children at 11 sites in seven countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania).
Read the fact sheet to learn more about the RTS,S malaria vaccine.
World Health Organization recommendation for pilot implementation of RTS,S
In October 2015, WHO jointly convened the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) to review all evidence regarding RTS,S relevant for global policy. SAGE/MPAC jointly recommended large-scale pilot implementation of RTS,S occur among children aged 5 to 17 months in 3–5 settings of moderate-to-high transmission in sub-Saharan Africa. WHO officially adopted the SAGE/MPAC recommendations in January 2016.
Scientific opinion by European regulators
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for RTS,S in July 2015. The CHMP gives scientific opinions, in cooperation with the WHO, on medicinal products for human use that are intended exclusively for markets outside of the European Union.
RTS,S Phase 3 results
Final results from the Phase 3 efficacy trial of RTS,S, published in The Lancet, showed that the vaccine candidate helped protect children and infants from clinical malaria for at least three years after first vaccination. Read more.