GSK seeks approval for malaria drug


Developed in partnership with non-profit PATH Malaria Vaccine Initiative (MVI), supported by the Bill & Melinda Gates Foundation, the vaccine known as RTS,S has been trialled over three years, with more than 15,000 infants and young children. GSK found the vaccine reduced the malaria cases in infants aged six to 12 weeks by around a quarter at first vaccination. It also showed that RTS,S continued to protect young children from clinical malaria up to 18 months after vaccination.Eleven research centres in seven African countries have been conducting the trial, together with GSK and PATH MVI.

The World Health Organisation (WHO) has indicated that a policy recommendation for the vaccine is possible as early as 2015 if it is granted a positive scientific opinion by the European Medicines Agency (EMA). GSK intends to submit a regulatory application for the vaccine to the EMA in 2014.

In 2010, 90 percent of all malaria deaths occurred in the WHO African Region, mostly among children under five years of age. However the vaccine will not be a substitute for other malaria prevention practices, particularly long lasting insecticide-treated nets, which are the best method of protecting young infants.

Sir Andrew Witty, chief executive of GSK, said: “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.”