Mosquirix to be used for vaccination of young children, together with established antimalarial interventions
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for GlaxoSmithKline's malaria vaccine Mosquirix (Plasmodium falciparum and hepatitis B vaccine), also known as RTS,S/AS01, for use outside the EU.
The vaccine was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU.
Mosquirix is intended for use in areas where malaria is regularly found, for the active immunisation of children aged six weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B.
The CHMP highlighted in its opinion that Mosquirix is for use in line with official recommendations that take into account the risk of Plasmodium falciparum malaria in different geographical areas and available malaria control interventions. These recommendations will be defined by the World Health Organization (WHO) and regulatory authorities in the non-EU countries where the vaccine would be used.
The main evidence for Mosquirix derives from a large clinical trial conducted in seven African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania), which showed that the vaccine provides modest protection against Plasmodium falciparum malaria in children in the 12 months following vaccination.
The vaccine was effective at preventing a first or only clinical malaria episode in 56% of children aged between 5-17 months and in 31% of children aged 6-12 weeks. The efficacy of the vaccine decreased after one year. The safety profile of the vaccine was considered acceptable. But because the studies showed that Mosquirix does not offer complete protection, and the protection it provides decreases in the longer term, it is important that established protective measures, for example insecticide-treated bed nets, continue to be used in addition to the vaccine.
Based on the results of the trial the CHMP concluded that despite its limited efficacy, the benefits of Mosquirix outweigh the risks in both age groups studied. The CHMP considered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very high.
The CHMP also agreed a follow-up programme with the company to ensure that the safety and effectiveness of Mosquirix is continuously monitored as described in the risk management plan.
GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in rR&D for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.