RTS,S

RTS,S/AS01 — trade name Mosquirix — is a recombinant protein-based malaria vaccine. Approved for use by European regulators in July 2015, it is not only the world's first licensed malaria vaccine, but the first vaccine licensed for use against a parasitic disease of any kind. The RTS,S vaccine was conceived of and created in the late 1980s by scientists working at SmithKline Beecham Biologicals (now GlaxoSmithKline Vaccines) laboratories in Belgium. The vaccine was further developed through a collaboration between GSK and the Walter Reed Army Institute of Research and has been funded in part by the PATH Malaria Vaccine Initiative and the Bill and Melinda Gates Foundation. Its efficacy ranges from 26 to 50% in infants and young children. It is considered to be a milestone advance in the worldwide campaign against malaria. On 23 October 2015, The World Health Organization's Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) jointly recommended a pilot implementation of the vaccine in Africa.

Potential malaria vaccines have been an intense area of research since the 1960s. SPf66 was tested extensively in endemic areas in the 1990s, but clinical trials showed it to be insufficiently effective. Other vaccine candidates, targeting the blood-stage of the malaria parasite's life cycle, have also been insufficient on their own. Among several potential vaccines under development that target the pre-erythrocytic stage of the disease, RTS,S has shown the most promising results so far.

RTS,S has been funded, most recently, by the non-profit PATH Malaria Vaccine Initiative (MVI) and GlaxoSmithKline with funding from the Bill and Melinda Gates Foundation.

The RTS,S-based vaccine formulation had previously been demonstrated to be safe, well tolerated, immunogenic, and to potentially confer partial efficacy in both malaria-naive and -experienced adults as well as children.

In November 2012, findings from a Phase III trial of RTS,S reported that it provided modest protection against both clinical and severe malaria in young infants. In October 2013, GlaxoSmithKline (GSK) reported that the RTS,S vaccine reduced the amount of cases amongst young children by almost 50 percent and among infants by around 25 percent, following the conclusion of an 18-month clinical trial. Data showed the protective effect after the 18 months, however, was less than had previously been seen after 12 months.

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