GSK Files EU MAA For World's First Malaria Vaccine

GlaxoSmithKline reported that it has filed a marketing authorization application to the European Medicines Agency (EMA) for its malaria vaccine dubbed RTS,S.

RTS,S is the scientific name of what could be the world’s first malaria vaccine. The name also reflects its composition, which includes the AS01 adjuvant system. The vaccine is designed to stimulate the body’s immune system against the P. falciparum malaria parasite once it penetrates the human host’s bloodstream or liver cells. RTS,S is developed mostly for use in sub-Saharan Africa, where 90 percent of malaria-related deaths take place — 77 percent of which occur in children under the age of 5.

Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise at GSK, said, “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.”

The investigational vaccine’s application will be assessed by the EMA in collaboration with the World Health Organization (WHO) under the Article 58 procedure. Article 58 is a provision for drugs manufactured in an EU member state for a disease recognized by the WHO, but which will be used exclusively outside the EU. Once the EMA issues a positive opinion for RTS,S, the WHO will indicate a policy recommendation possibly by the end of 2015.

The company revealed that it has spent more than $350 million to develop the vaccine and expects to invest an additional $260 million towards its completion. The company has received over $200 million in financial support from the Bill and Melinda Gates Foundation through the PATH Malaria Vaccine Initiative.

Upon the vaccine’s approval, GSK said it will sell RTS,S for 5 percent more than its manufacturing costs and will invest the profit back into R&D for second-generation malaria vaccines or for other tropical diseases.