Ghana, Kenya, and Malawi to take part in WHO malaria vaccine
pilot programme
The World Health Organization Regional Office for Africa
(WHO/AFRO) announced on April 24, 2017, that Ghana, Kenya, and Malawi will
partner with WHO in the Malaria Vaccine Implementation Programme (MVIP) that
will make the RTS,S vaccine available in selected areas of the three countries,
beginning in 2018. WHO/AFRO announced the countries at a high-level forum in
Nairobi, Kenya, organized by WHO and the Ministry of Health of Kenya in advance
of World Malaria Day.
The MVIP is being coordinated and led by WHO in close
collaboration with Ministries of Health in the participating countries and a
range of in-country and international partners. The MVIP will take place in
Ghana, Kenya, and Malawi, beginning in 2018, with preparations already
underway.
By 2020, the MVIP is expected to provide initial insights on
the programmatic feasibility of delivering the RTS,S/AS01 vaccine candidate
(trade name Mosquirix™) in real-life settings and on the safety profile of
RTS,S in the context of routine use. The MVIP will continue monitoring
feasibility and safety through its expected conclusion in 2022, while also
generating results on the vaccine’s impact on childhood survival. The results
of the MVIP will help inform future decisions on the wider-scale deployment of
the vaccine.
RTS,S is expected to be approved by the National Regulatory
Authorities (NRAs) in each of the three countries participating in MVIP for use
in the context of the pilot evaluation and Phase 4 studies.
Visit the WHO/AFRO website (link is external) to read their
press release.
Development of RTS.S
RTS,S is the candidate malaria vaccine furthest along in
development globally, the outcome of a long-standing collaboration between PATH
and GSK that began in 2001. RTS,S is the first and, to date, the only vaccine
to show a protective effect against malaria among young children in Phase 3
clinical trials.
RTS,S is an injectable vaccine that provides partial
protection against malaria in young children. Like vaccines generally, RTS,S
aims to trigger the body’s own immune system to defend against disease, in this
case, malaria caused by Plasmodium falciparum, the most deadly species of the
malaria parasite globally and the most prevalent in Africa. The large-scale
Phase 3 efficacy and safety trial of RTS,S (which concluded in January 2014)
showed that the vaccine candidate could provide meaningful public health
benefit by reducing the burden of malaria when used alongside currently
available interventions such as bednets and insecticides.
Beginning in the 1980s, early development was undertaken by
GSK, working in close collaboration with the Walter Reed Army Institute of
Research. In January 2001, GSK and PATH’s Malaria Vaccine Initiative (MVI), with
grant money from the Bill & Melinda Gates Foundation to PATH, entered into
a public-private partnership to develop the vaccine for infants and young
children in sub-Saharan Africa.
Between mid-2009 and early 2014, MVI, GSK, and leading
research centers in Africa conducted a Phase 3 efficacy and safety trial of
RTS,S that involved 15,459 infants and young children at 11 sites in seven
countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and
Tanzania). Today, partners continue to work on next steps for RTS,S along the
pathway to possible implementation.
World Health Organization recommendation for pilot
implementation of RTS,S
In October 2015, WHO jointly convened the Strategic Advisory
Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory
Committee (MPAC) to review all evidence regarding RTS,S relevant for global
policy. SAGE/MPAC jointly recommended large-scale pilot implementation of RTS,S
occur among children aged 5 to 17 months in 3–5 settings of moderate-to-high
transmission in sub-Saharan Africa. WHO officially adopted the SAGE/MPAC
recommendations in January 2016.
Visit the WHO website to read their position paper (link is
external).
Scientific opinion by European regulators
The Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) adopted a positive scientific opinion for
RTS,S in July 2015. The CHMP gives scientific opinions, in cooperation with the
WHO, on medicinal products for human use that are intended exclusively for
markets outside of the European Union.
Final results from the Phase 3 efficacy trial of RTS,S,
published in The Lancet, showed that the vaccine candidate helped protect
children and infants from clinical malaria for at least three years after first
vaccination.
Malaria vaccine candidate has demonstrated efficacy over 3-4
years of follow-up.