Immunization, Vaccines and Biologicals

Malaria Vaccine Implementation Programme (MVIP)

RTS,S/AS01 is the first and, to date, the only vaccine to show partial protection against malaria in young children. In 2016, WHO recommended pilot implementation of the malaria vaccine to further evaluate its public health use as a complementary malaria control tool that could be added to the core package of existing preventive, diagnostic, and treatment measures recommended by WHO. Vaccinations through routine immunization programmes began in selected areas of Ghana and Malawi in April 2019, and will soon begin in Kenya.

WHO recommends pilot introduction

In October 2015, after a thorough review of the Phase 3 trial results, 2 independent WHO advisory groups – the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) – jointly called for pilot implementation of the vaccine in 3 to 5 settings in sub-Saharan Africa.

In a position paper published on 29 January 2016, WHO officially adopted the joint recommendation of SAGE and MPAC; in doing so, the Organization recognized the public health potential of the RTS,S vaccine while also acknowledging the need for further evaluation before considering wide-scale deployment. There is currently no WHO policy recommendation for the large-scale use of the RTS,S malaria vaccine beyond the pilot programme.

MVIP coordinates phased vaccine introductions in Ghana, Kenya and Malawi

The MVIP was established by WHO to coordinate and support the phased introduction of the vaccine in selected areas of Africa through country-led routine immunization. The Programme was designed to address outstanding questions related to the public health use of the vaccine. Specifically, the MVIP will assess the feasibility of administering the required 4 doses of the vaccine in children; the vaccine’s role in reducing childhood deaths; and its safety in the context of routine use.

Phased vaccine introductions in selected areas of Ghana, Kenya, and Malawi are led by ministries of health through their national immunization programmes. Data and information derived from the MVIP will inform a WHO policy recommendation on the broader use of the vaccine.

About the vaccine

The safety and efficacy of the RTS,S/AS01 vaccine has been evaluated in clinical studies, including a large Phase 3 clinical trial conducted between 2009 and 2014. The trial enrolled more than 15 000 young children and infants in 7 sub-Saharan African countries, representing a range of malaria transmission settings. Among children aged 5–17 months who received 4 doses of RTS,S/AS01, the vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of follow-up and about 3 in 10 (29%) cases of severe malaria, with significant reductions also seen in overall hospital admissions and in admissions due to malaria or severe anaemia. The vaccine also reduced the need for blood transfusions, which are required to treat life-threatening severe malaria anaemia, by nearly 3 in 10 (29%).

Public-private collaboration partners

The MVIP is a collaboration of public and private partners, coordinated by WHO. The vaccine introduction in selected areas of Ghana, Kenya, and Malawi will be led by ministries of health through their national immunization programmes. In-country research partners, commissioned by WHO, will lead the evaluation of the vaccine implementation. PATH provides technical and project management support for the MVIP and is leading studies on healthcare utilization and the economics of vaccine implementation. The vaccine manufacturer, GSK, is donating up to 10 million doses of RTS,S/AS01 for use in the MVIP. As the programme progresses, WHO expects other partners to become involved.

Financing for the MVIP through 2020 has been mobilized through an unprecedented collaboration between three major global health funding bodies: Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Unitaid.