By Wallace Mawire
The World Health Organization Regional Office for Africa (WHO/AFRO)
has announced that Ghana, Kenya, and Malawi will take part in a
WHO-coordinated malaria vaccine implementation programme (MVIP) that
will make the world’s first malaria vaccine available in selected
areas, beginning in 2018.
It is reported that the injectable vaccine, RTS,S, was developed to
protect young children from the most deadly form of malaria caused by
Plasmodium falciparum. RTS,S will be assessed in the pilot programme
as a complementary malaria control tool that could potentially be
added to the core package of WHO- recommended measures for malaria
“The prospect of a malaria vaccine is great news. Information gathered
in the pilot programme will help us make decisions on the wider use of
this vaccine”, said Dr Matshidiso Moeti, WHO Regional Director for
Africa. “Combined with existing malaria interventions, such a vaccine
would have the potential to save tens of thousands of lives in
Africa,” she added.
It is also reported that Africa bears the greatest burden of malaria
worldwide. Global efforts in the last 15 years have led to a 62
percent reduction in malaria deaths between 2000 and 2015, yet
approximately 429,000 people died of the disease in 2015, the majority
of them young children in Africa.
The WHO pilot programme will assess whether the vaccine’s protective
effect in children aged 5 to 17 months old during Phase 3 testing can
be replicated in real-life. Specifically, the pilot programme will
assess the feasibility of delivering the required four doses of RTS,S,
the vaccine’s potential role in reducing childhood deaths, and its
safety in the context of routine use.
RTS,S was developed by GSK and is the first malaria vaccine to have
successfully completed a Phase 3 clinical trial. The trial was
conducted between 2009 and 2014 through a partnership involving GSK,
the PATH Malaria Vaccine Initiative (with support from the Bill &
Melinda Gates Foundation), and a network of African research sites in
seven African countries—including Ghana, Kenya, and Malawi.
RTS,S is also the first malaria vaccine to have obtained a positive
scientific opinion from a stringent medicines regulatory authority,
the European Medicines Agency (EMA). The opinion indicated that, in
EMA’s assessment, the quality of the vaccine and its risk-benefit
profile was favorable from a regulatory perspective.
In October 2015, two independent WHO advisory groups, comprised of the
world’s foremost experts on vaccines and malaria, recommended pilot
implementation of RTS,S in three to five settings in sub-Saharan
Africa. The recommendation came from the Strategic Advisory Group of
Experts (SAGE) on Immunization and the Malaria Policy Advisory
Committee (MPAC), following a joint review of all available evidence
on the vaccine’s safety and efficacy. WHO formally adopted the
recommendation in January 2016.
The three countries were selected to participate in the pilot
programme based on the following criteria such as high coverage of
long-lasting insecticidal nets (LLINs), well-functioning malaria and
immunisation programmes, a high malaria burden even after scale-up of
LLINs, and participation in the Phase 3 RTS,S malaria vaccine trial.
Each of the three countries will decide on the districts and regions
to be included in the pilots. High malaria burden areas will be
prioritized, as this is where the benefit of the vaccine is predicted
to be highest. Information garnered from the pilot will help to inform
later decisions about potential wider use of the vaccine.
The malaria vaccine will be administered via intramuscular injection
and delivered through the routine national immunization programmes.
WHO is working with the three countries to facilitate regulatory
authorization of the vaccine for use in the pilots through the African
Vaccine Regulatory Forum (AVAREF). Regulatory support will also
include measures to enable the appropriate safety monitoring of the
vaccine and rigorous evaluation for eventual large scale use.
Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS,
Tuberculosis and Malaria and UNITAID are partnering to provide $49.2
million for the first phase of the pilot programme (2017-2020), which
will be complemented by in-kind contributions from WHO and GSK.