Malaria Vaccine Implementation Programme (MVIP)

Partnership objective

The malaria vaccine implementation programme (MVIP) has been designed to address several outstanding questions related to the use of the RTS,S vaccine against P falciparum malaria parasite in childrenSpecifically, 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 safety in the context of routine use.

Approved by both the European Medicines Agency (EMA) and the WHO, the vaccine acts against Plasmodium falciparum, the most deadly malaria parasite globally and the most prevalent in Africa. Approved by both the European Medicines Agency (EMA) and the WHO, the vaccine acts against Plasmodium falciparum, the most deadly malaria parasite globally and the most prevalent in Africa. Copyright GSK

What are the health needs and challenges?

Malaria is transmitted by female members of the Anophelesmosquito family, which feed on human blood. The initial symptoms of the disease include fever, headache, malaise, fatigue, nausea, muscular pains and mild diarrhoea. Infection can rapidly progress, leading to more severe symptoms, including delirium and convulsions, followed by coma and death.

Despite progress made using currently available disease control measures, malaria remains a leading cause of death in children in sub-Saharan Africa. According to WHO, there were 212 million new malaria cases and 429,000 malaria deaths in 2015, with Africa bearing the greatest burden. Research shows that malaria slows economic growth in Africa by up to 1.3% each year and costs Africa’s economy US$12 billion per year.  

Malaria can be prevented by controlling the breeding of malaria carrying mosquitoes and sleeping under insecticide-treated mosquito nets. It can be treated effectively too, using effective drugs at the correct dose for the right length of time. However, vaccines offer an economical and effective means of preventing the disease and deaths each year. 

Description of partnership activities and how they address needs and challenges

RTS,S/AS01 (RTS,S) – also known as Mosquirix™ – is an injectable vaccine that provides partial protection against malaria in young children. GSK led the development of RTS,S over a 30-year period and conducted a 5-year Phase 3 trial between 2009 and 2014 through a partnership with MVI (with support from the Bill & Melinda Gates Foundation), and a network of African research centres in 7 countries. Approved by both the European Medicines Agency (EMA) and the WHO, the vaccine acts against Plasmodium falciparum, the most deadly 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 among young children in Phase 3 clinical trials.

Following an announcement by the WHO on 24 April 2017, Ghana, Kenya and Malawi will introduce the vaccine in selected areas as part of a large-scale pilot implementation programme, due to begin in 2018. It will be the first malaria vaccine provided to young children through routine immunization programmes, which will be delivered to half of the more than 750,000 participating children. 

Summary of impact and forward looking information

The first phase of the programme (2017–2020) provides initial insights on the feasibility of delivering the vaccine in real-life settings and on the safety profile of RTS,S in the context of routine use. The second phase of the MVIP (2021–2022) will continue to monitor feasibility and safety while also generating results on the vaccine’s impact on child survival. Taken together, these results will help inform future decisions on the wider-scale deployment of the vaccine.

GSK is also conducting a number of Phase 4 studies in regions where the RTS,S vaccine will be deployed. These studies will gather 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.

Partnership information

Company(ies) GlaxoSmithKline

Partner(s) Bill and Melinda Gates Foundation, PATH Malaria Vaccine Initiative (MVI), World Health Organization (WHO)

Type of Partner(s) IGOs, NGOs, PDPs

Therapeutic Focus Infectious Diseases

Disease(s) Malaria

Program Type(s) Prevention Programs - Vaccines, Research & Development - Development of Treatments, Research & Development - Pediatric R&D

Targeted Population(s) Children, People with low income

Region(s) Sub-Saharan Africa

Number of Countries 3

Country(ies) Ghana, Kenya, Malawi

Start Date 2018

More information WHO - Programme Advisory Group for the MVIP GSK and PATH welcomes the RTS,S implementation

Anticipated completion date Ongoing