England’s leading drug producer, GlaxoSmithe Kline (GSK) will seek marketing approval for the world’s first malaria vaccine next year after trial data showed a significantly cut cases of the malaria in African children.
The vaccine known as RTS,S was found, after 18 months of follow-up, to have almost halved the number of malaria cases in young children in the trial, and to have reduced by around a quarter the number of malaria cases in infants.
Malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people a year, mainly babies in the poorest parts of sub-Saharan Africa, and scientists say an effective vaccine is key to attempts to eradicate it.
“Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA),” GSK, which has been developing the vaccine for three decades, said in a statement.
It added that the United Nations health agency, World Health Organization (WHO), has indicated it may recommend use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its licence application.
Yet hopes that RTS,S would be the final answer were dampened last year when results from a final-stage trial with 6,537 babies aged six to 12 weeks showed the shot provided only modest protection, reducing episodes of the disease by 30 percent compared to immunisation with a control vaccine.
GSK is developing RTS,S with the non-profit PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI. “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,” said Halidou Tinto, a lead investigator on the RTS,S trial from Burkina Faso.