The European Medicines Agency’s Committee for Medicinal Products for Human Use(CHMP) has adopted a positive scientific opinion for Mosquirix (Plasmodium falciparumand hepatitis B vaccine), for use outside the European Union (EU).
The malaria vaccine Mosquirix, also known as RTS,S/AS01, was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety andefficacy 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 against hepatitis B. After decades of research into malaria vaccinations, Mosquirix is the first vaccine for the disease to be assessed by a regulatory agency.
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.
As in all Article 58 procedures, the CHMP worked closely with other experts, including from WHO and regulatory authorities from the relevant countries. In its assessment, theCHMP applied the same rigorous standards as for medicines to be marketed within the EU.