GSK Submits Malaria Vaccine Candidate for EMA Approval

GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.

RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). It is estimated that malaria accounts for approximately 90% of deaths in SSA, of which 77% occur in children below the age of five.

EMA and the World Health Organization (WHO) will collaborate on the assessment of the vaccine.

WHO has indicated that a policy recommendation (i.e., a formal review process designed to assist the development of optimal immunization schedules for diseases that have a global public health impact, such as malaria) may be possible by the end of 2015 if EMA grants a positive opinion.

A positive opinion from the EMA would also be the basis for marketing authorization applications to National Regulatory Authorities (NRAs) in SSA countries. A review by a European medicines agency is required by the majority of African countries prior to registration of a medicinal product manufactured in Europe. If positive, these regulatory decisions would help pave the way toward the large-scale implementation of the vaccine through African national immunization programs.