GlaxoSmithKline (GSK) has received a positive scientific opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its malaria candidate vaccine, Mosquirix (RTS,S,), to prevent the disease in children aged six weeks to 17 months.
The positive opinion will allow the World Health Organisation (WHO) to formulate a policy recommendation on the use of the vaccine in national immunisation programmes once approved by national regulatory authorities.
Developed in collaboration with the PATH Malaria Vaccine Initiative (MVI), Mosquirix has been designed to prevent malaria caused by the Plasmodium falciparum parasite that is mostly predominant in sub-Saharan Africa (SSA).
The scientific opinion was based on data from the Phase III clinical trial programme, which involved around 16,000 young children.
The trial was conducted by 13 African research centres in eight African countries, including Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania.
According to GSK, the data showed that over the first 18 months following three doses of Mosquirix, malaria cases reduced by almost half in children aged five to 17 months at the time of first vaccination and by 27% in infants aged six to 12 weeks.
WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) will now assess the evidence base for RTS,S.
They will make a joint policy recommendation for how it might be used alongside other tools to prevent malaria in the event the vaccine candidate is approved by national regulatory authorities in SSA.
GSK will also submit an application to the WHO for pre-qualification of RTS,S, following the WHO policy recommendation.
The company will then apply for marketing authorisation in countries in sub-Saharan Africa on a country-by-country basis, once a WHO pre-qualification is granted.
Both WHO policy recommendation and WHO pre-qualification will help Gavi, the vaccine alliance, to introduce RTS,S in eligible African countries with the support of UNICEF.
Image: Ring-forms and gametocytes of Plasmodium falciparum in human blood. Photo: courtesy of TimVickers.