GSK, one of the global leaders in research-based pharmaceuticals, has announced its submission for a regulatory application for its first malaria vaccine candidate – RTS,S – to the European Medicines Agency (EMA).

RTS,S is the scientific name for the malaria vaccine candidate which also contains the AS01 adjuvant system.

According to the Centers for Disease Control and Prevention (CDC), between 1,500 to 2,000 cases of malaria are reported each year in the U.S., nearly all in recent travelers.

The submission will adhere to Article 58, which permits the EMA to determine the safety, quality and adequacy of a vaccine candidate for an aliment that’s recognized by the World Health Organization (WHO) and intended to be used exclusively outside of the EU regions. The product must meet the same level of standards as vaccines that are to be used within the EU. RTS,S met the criteria for this type of evaluation as was determined by an agreement between the Committee for Medicinal Products for Human Use (CHMP) and the WHO.

RTS,S is targeted specifically to the Plasmodium falciparum malaria parasite which is the most rampant form of malaria in sub-Saharan Africa. Approximately 90 percent of malaria deaths happen within this part of the continent, with 77 percent of these cases occurring in children younger than five years of age.

Dr. Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK is optimistic about the potential of this vaccine to lower the death rate of this type of malaria among citizens of sub-Saharan Africa.

“This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria,” Dr. Biernaux said in a statement.