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Malaria Vaccine Implementation Programme (MVIP)

Active Since: 2017

Contributing to SDGs…

Addressing several outstanding questions related to the use of the RTS,S vaccine against the P falciparum malaria parasite in children.

Brian Chimpuku administers the malaria vaccine to a five-month old child, Mkaka Primary School Outreach, Malawi (Credit: PATH)

MEMBER COMPANIES

PARTNER ORGANISATIONS

  • Global NGOs

    PATH Malaria Vaccine Initiative (MVI)

    Contribution

    As part of the MVIP, PATH will support WHO in project management and communications. PATH will also lead a qualitative study on health care utilization and assess the economics of vaccine implementation.

  • Intergovernmental Organizations and Multilaterals

    World Health Organization (WHO)

    Contribution

    WHO is responsible for programme oversight and coordination of all aspects of the MVIP; this includes rigorous evaluations of the feasibility of implementing the 4-dose vaccination schedule, and its impact and safety in the context of routine immunization. WHO will also provide technical assistance to the Ministries of Health in Ghana, Kenya and Malawi as the countries introduce the vaccine in selected areas through their national immunization programmes.

Objectives

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.

SDGs THE PARTNERSHIP CONTRIBUTES TO

SDG 3: Good Health and Wellbeing

  1. 3.2: Reduce Under-5 Mortality 
  2. 3.3: Communicable Diseases & NTDs
  3. 3.C: Health workforce

SDG 9: Industry Innovation and Infrastructure

SDG 10: Reduced Inequalities

SDG 17: Partnerships for the Goals