RTS,S malaria vaccine candidate

Scientific opinion
Phase 3 results
RTS,S timeline
RTS,S related resources

RTS,S (also known as MosquirixTM) is the malaria vaccine candidate that is most advanced in development globally. Its early development, beginning in the 1980s, 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) has adopted a positive scientific opinion for RTS,S. The CHMP gives scientific opinions, in cooperation with the World Health Organization (WHO), on medicinal products for human use that are intended exclusively for markets outside of the European Union. The next step for RTS,S is further review by WHO, which has indicated that a policy recommendation is possible by the end of this year.

Read GSK's press release.
Read the EMA's press release.
Read our statement.

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.

RTS,S timeline

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.

RTS,S related resources

View more resources.