The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), for use outside the European Union (EU).
After many years of research into a malaria vaccine, Mosquirix is the first vaccine for the disease to be assessed by a regulatory body.
The vaccine was assessed under a regulatory procedure (Article 58) that allows the 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 6 weeks to 17 months against malaria caused by the Plasmodium falciparum parasite and, due to the vaccine’s composition, against hepatitis B.
The main evidence supporting Mosquirix derives from a large clinical trial conducted in 7 African countries – Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. Data from this trial showed that Mosquirix 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.
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.
However, as 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.
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.
According to WHO, in 2013 627,000 deaths from malaria were reported globally, of which 562,000 (90%) occurred in the African region mostly among children under the age of 5 (82%).