Malaria Vaccine Implementation Programme (MVIP)
Addressing several outstanding questions related to the use of the RTS,S vaccine against the P falciparum malaria parasite in children.
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The Malaria Vaccine Implementation Programme (MVIP) has been designed to address several outstanding questions related to the use of the RTS,S/AS01 vaccine againstPlasmodium falciparum, the deadliest malaria parasite globally and the most prevalent in Africa. Specifically, the MVIP is assessing the operational feasibility of administering the required 4 doses of the vaccine in children; the vaccine’s potential role in reducing childhood deaths; and its impact and safety in the context of routine use.
The RTS,S/AS01 malaria vaccine is an injectable vaccine that provides partial (approx. 50% protection over the first year of follow-up) protection against malaria in young children. The vaccine acts against Plasmodium falciparum, the deadliest malaria parasite globally and the most prevalent in Africa. It is the first and, to date, the only vaccine to show a protective effect against malaria in young children in Phase 3 clinical trials. Despite the moderate vaccine efficacy, the vaccine was shown to be able to prevent on average more than 6 malaria episodes for every fully vaccinated child living area of high malaria transmission intensity.
GSK led the development of RTS,S/AS01 for more than 35-years with partners including PATH.GSK conducted a 5-year Phase 3 trial a network of 11 African research centres in 7 countries. A stringent regulatory authority—the European Medicines Agency (EMA)—issued a positive scientific opinion on the vaccine in July 2015. In January 2016, WHO recommended to pilot introductions of the vaccine in sub-Saharan Africa in order to gather operational research data on the feasibility of delivering the vaccine in real-life settings, on the safety and impact of the vaccine. The country-led and WHO-coordinated pilots, known as the Malaria Vaccine Implementation Programme (MVIP), began in 2019 when Ghana, Kenya and Malawi introduced the vaccine in selected areas through routine immunization programmes.
GSK is also conducting a number of Phase 4 studies in regions where the RTS,S/AS01 pilot implementation program (MVIP) is being conducted. These studies are gathering additional information on the vaccine’s effectiveness and on any side effects associated with its long-term use and will complement data from the pilot evaluations led by WHO.
In 2021, the vaccine was recommended by WHO for broad use in children at risk in sub-Saharan Africa and in other regions with moderate to high transmission of malaria caused by Plasmodium falciparum. The recommendation was informed by findings from the first 2 years of the MVIP, as well as other available evidence. The WHO recommendation paved the way for the board of Gavi, the Vaccine Alliance to approve a malaria vaccination program to support the broader rollout of the vaccine in Gavi-eligible countries. The MVIP is expected to end in 2023 when full data is expected to be gathered.
- Infectious and Parasitic Disease
- People with low incomes
SGDs the partnership contributes to
- 3.8: Achieve universal health coverage
- 3.C: Health workforce
Infectious and Parasitic Disease