Assessing the safety, impact and effectiveness of RTS, S/AS01E malaria vaccine following its introduction in three sub-Saharan African countries: methodological approaches and …
Publication Date
2022-12Author
N Praet, KP Asante, MC Bozonnat, EJ Akité, PO Ansah, L Baril, O Boahen, ...
Metadata
Show full item recordAbstract/ Overview
Following a 30-year development process, RTS,S/AS01E (GSK, Belgium) is the frst malaria vaccine to
reach Phase IV assessments. The World Health Organization-commissioned Malaria Vaccine Implementation Pro‑
gramme (MVIP) is coordinating the delivery of RTS,S/AS01E through routine national immunization programmes in
areas of 3 countries in sub-Saharan Africa. The frst doses were given in the participating MVIP areas in Malawi on 23
April, Ghana on 30 April, and Kenya on 13 September 2019. The countries participating in the MVIP have little or no
baseline incidence data on rare diseases, some of which may be associated with immunization, a defcit that could
compromise the interpretation of possible adverse events reported following the introduction of a new vaccine in the
paediatric population. Further, efects of vaccination on malaria transmission, existing malaria control strategies, and
possible vaccine-mediated selective pressure on Plasmodium falciparum variants, could also impact long-term malaria
control. To address this data gap and as part of its post-approval commitments, GSK has developed a post-approval
plan comprising of 4 complementary Phase IV studies that will evaluate safety, efectiveness and impact of RTS,S/
AS01E through active participant follow-up in the context of its real-life implementation.