GSK will file based on Phase III data for RTS,S in Malaria

New data from a Phase III study of Malarial vaccine RTS,S, from Glaxo Smith Kline, in Africa's largest-ever clinical trial involving almost 15,500 children in seven countries, demonstrated that over 18 months of follow-up, RTS,S was shown to almost halve the number of Malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the Malaria cases in infants (aged 6-12 weeks at first vaccination). An average of 941 cases of clinical malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated in this age group, noting that a child can contract more than one case of Malaria. Severe Malaria cases were reduced by 36%.

Overall, vaccine efficacy declined over time: Previous results from one year follow-up of the Phase III trial showed that efficacy of RTS,S was 56% against clinical Malaria and 47% against severe Malaria for the 5-17 month-old age group and 31% against clinical Malaria and 37% against severe Malaria in the 6-12 week-old age group. GSK intends to submit, in 2014, a regulatory application to the European Medicines Agency and hopes that the World Health Organization may recommend the use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its application. Data was presented at the Multilateral Initiative on Malaria Pan African Conference.