GSK files RTS,S Malaria vaccine at EMA.

GSK announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU. This assessment is done by the EMA in collaboration with the WHO, and requires products to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the CHMP after agreement from WHO that RTS,S met criteria for such an evaluation.

RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90 per cent of estimated deaths from malaria occur in SSA, and 77 per cent of these are in children under the age of 5.