The World Health Organization (WHO) recommends pilot implementations for GSK's malaria vaccine candidate RTS,S (also known as MosquirixTM).
The WHO recommendation for large-scale pilot implementations was issued in a position paper for RTS,S that was published in the Weekly Epidemiological Record (WER) on January 29, 2016. The recommendation confirms the advice provided in the fall of 2015 by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Committee (MPAC).
The WHO position paper “…recommends that the pilot implementations use the 4-dose schedule of the RTS,S/AS01 vaccine in 3–5 distinct epidemiological settings in sub-Saharan Africa, at subnational level, covering moderate-to-high transmission settings,” with three doses administered to children between 5 months and 9 months of age, followed by a fourth dose 15–18 months later.
WHO further recommends that the pilots involve sufficiently large populations to assess, among other things, (1) the feasibility of providing all four doses of RTS,S to the target age group through existing health services; (2) the impact of RTS,S on child mortality; and (3) evidence of any causal relationship between RTS,S and either meningitis or cerebral malaria, in the context of surveillance of adverse events; as well as the compilation of evidence on the functioning of country immunization programs and the use of currently recommended malaria control measures.
Early development of RTS.S
RTS,S is the malaria vaccine candidate that is farthest along in development globally. Beginning in the 1980s, its early development was undertaken by GSK in close collaboration with the Walter Reed Army Institute of Research. In January 2001, GSK and MVI, with grant money from the Bill & Melinda Gates Foundation to MVI, 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). Today, partners continue to work on next steps for RTS,S along the pathway to possible implementation.
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.
Navigate through the RTS,S timeline below to find out more about the development of RTS,S. Click on a year or year range along the bottom to see that section of the timeline.