GSK’s malaria vaccine could be available by 2015

The world's first malaria vaccination may be available as early as 2015, says the World Health Organisation, following the announcement of further positive phase 3 clinical trial data of GlaxoSmithKline's vaccine candidate, RTS,S.

Results show that RTS,S continued to protect young children and infants from clinical malaria up to 18 months after vaccination. RTS,S was shown to almost half 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).

"It appears that the RTS,S candidate vaccine has the potential to have a significant public health impact. Preventing substantial numbers of malaria cases in a community would mean fewer hospital beds filled with sick children. Families would lose less time and money caring for these children and have more time for work or other activities. And of course the children themselves would reap the benefits of better health."

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.

Based on these data, GSK now intends to submit a regulatory application to the European Medicines Agency (EMA) next year. If the EMA grants the vaccine with a positive opinion, then it could have a policy recommendation by 2015.

"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. 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."

Sir Andrew Witty, CEO of GSK.

The clinical trial is being conducted by eleven African research centres in seven African countries, together with GSK and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI.