GSK planning EMA submission for malaria vaccine

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said next year it plans to submit a regulatory application to EMA for its RTS,S vaccine to prevent malaria infection in infants and children. The news came after the pharma published additional data from a Phase III trial showing three doses of the vaccine reduced the incidence of clinical malaria over an 18-month period following vaccination compared to the non-malaria comparator vaccine group. In 8,923 children aged 5-17 months, RTS,S reduced the incidence of malaria over an 18-month period by 46% vs. the non-malaria comparator vaccine group, and in 6,537 infants aged 6-12 weeks, the vaccine reduced the incidence of clinical malaria by 27%.

The double-blind, African trial enrolled 15,460 children to receive a non-malaria comparator vaccine or three doses of RTS,S given at one-month intervals with or without a booster dose given 18 months after the third dose. The 18-month data were presented at the Multilateral Initiative on Malaria Pan African meeting in South Africa. ...