RTS,S/AS01 (RTS,S) is the world’s first malaria vaccine shown to provide partial protection against malaria in young children. The vaccine is being provided to young children through national immunization programs in parts of three sub-Saharan African countries as part of a pilot introduction that began in 2019.
RTS,S received a positive scientific opinion from the European Medicines Agency in 2015 and was recommended by the World Health Organization (WHO) for a pilot implementation program to assess the feasibility of administering the required four doses of the vaccine in children, the vaccine’s role in reducing childhood deaths and severe malaria, and its safety in the context of routine use. The country-led and WHO-coordinated Malaria Vaccine Implementation Programme will also provide data and information for a WHO policy recommendation on the broader use of the vaccine.
In January 2021, PATH, GSK, and Bharat Biotech (BBIL) announced the signing of a product transfer agreement for the RTS,S/AS01 malaria vaccine, following a comprehensive and competitive selection process conducted by GSK and PATH, in consultation with WHO. BBIL will take over the production activities of RTS,S (excluding the adjuvant which will continued to be manufactured by GSK), over time, and become the vaccine’s sole supplier by 2029, at the latest. Until that time, GSK will continue to meet its existing commitment to malaria vaccine supply, including the donation of 10 million doses for the MVIP. The product transfer agreement reflects the efforts of GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a WHO recommendation for broader use and a commitment of sustained funding. To learn more about the agreement, read the press release.
RTS,S was created in 1987 by scientists working in GSK laboratories. In early 2001, GSK and PATH—with support from the Bill & Melinda Gates Foundation—entered into a partnership to develop the vaccine for infants and young children living in malaria endemic regions in sub-Saharan Africa. Its efficacy was established in a Phase 3 trial that concluded in 2014.
RTS,S aims to trigger the immune system to defend against the first stages of malaria when the Plasmodium falciparum parasite enters the human host’s bloodstream through a mosquito bite and infects liver cells. The vaccine is designed to prevent the parasite from infecting the liver, where it can mature, multiply, reenter the bloodstream, and infect red blood cells, which can lead to disease symptoms. To learn more about RTS,S, read the fact sheet.