Phase III trial data prompts UK drugmaker to submit RTS,S to European Medicines Agency for possible approval in 2014
GlaxoSmithKline (GSK) will seek marketing approval for the world's first anti malaria vaccine next year after Phase III trial data presented in Durban, South Africa this week, showed that it protected young children and infants in Africa from malaria up to 18 months after vaccination.
The vaccine, known as RTS,S, was found to have almost halved the number of malaria cases in children aged 5-17 months, and by a quarter in infants aged 6-12 weeks at first vaccination.
Based on these results, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (WHO) has indicated that it may recommend use of the RTS,S vaccine from as early as 2015 if the EMA drug regulators support its licence application.
Eleven African research centres in seven African countries are conducting this trial, together with GSK and the PATH Malaria Vaccine Initiative (MVI), with funding from the Bill & Melinda Gates Foundation to MVI.
'In Africa we experience nearly 600,000 deaths annually from malaria, mainly children under five years of age,' said Halidou Tinto, Principal Investigator from the Nanoro, Burkina Faso trial site and chair of the Clinical Trials Partnership Committee (CTPC), which oversees the RTS,S Phase III programme. 'Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.'
The efficacy of RTS,S was evaluated in the context of existing measures used to control malaria, such as insecticide treated bed nets, which were used by 78% of children and 86% of infants in the trial.
We need more tools to battle this terrible disease
In these latest results, children aged 5-17 months at first vaccination with RTS,S experienced 46% fewer cases of malaria, compared with children immunised with a control vaccine. An average of 941 cases of malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated in this age group. Severe malaria cases were reduced by 36%; and 21 cases of severe malaria were prevented for every 1,000 children vaccinated. Malaria hospitalisations were reduced by 42%.
Infants aged 6-12 weeks had 27% fewer cases of malaria and over 18 months of follow-up, 444 cases were prevented for every 1,000 infants vaccinated.
'It appears that the RTS,S candidate vaccine has the potential to have a significant public health impact,' said Tinto.
Overall, vaccine efficacy declined over time. Previous data 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.
RTS,S continued to display an acceptable safety and tolerability profile during the 18 month follow-up.
Further data from 32 months' follow-up and the impact of a fourth ‘booster’ dose given 18 months after the initial three doses are expected to become available in 2014.
'We’re very encouraged by these latest results, which show that RTS,S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa,' said Sir Andrew Witty, CEO of GSK.
'While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive.
'These data support our decision to submit a regulatory application for the vaccine candidate which, if successful, would bring us a step closer to having an additional tool to fight this deadly disease.
'We are grateful to the scientists across Africa and GSK and to our partners who have worked tirelessly for almost 30 years to bring us to this point.'