Re: Musings on malaria morbidity and mortality after the new Mosquirix® vaccine

Importance of pilot implementation and Phase IV studies and pending questions: The Malaria Vaccine Implementation Project (MVIP) is coordinated by the World Health Organisation (WHO) and led by African health authorities in Ghana, Kenya and Malawi. In Ghana, the MVIP is led by Ministry of Health/Ghana Health Service and evaluated by a consortium of researchers from University of Ghana, University of Health and Allied Sciences, Agogo Malaria Centre, and the Research and Development Division of Ghana Health Service. The project is designed to address several outstanding questions related to the public health use of the vaccine. Additionally, Phase IV studies are ongoing to further assess the safety of the vaccine in Ghana (Kintampo and Navrongo) as a standard regulatory requirement for new vaccines. Indeed, this approach has been used for the introduction of other vaccines in Ghana such as the human papilloma virus vaccine. 2 Specifically, the MVIP will provide data to the Ministry of Health and partners on how best to deliver the required four doses of the vaccine in routine settings; assess the vaccine’s full potential role in reducing childhood deaths; and establish the vaccine’s safety profile in the context of routine use. Since the Phase III study was not intended to measure the impact of the vaccine on mortality, the data from MVIP will confirm or refute the impact of the malaria vaccine on mortality as determined in the mathematical models outlined by Penny M et. al.3