British drugmaker GlaxoSmithKline (GSK) is to seek marketing approval for the world’s first malaria vaccine next year after trial data showed the shot significantly cut cases of the disease 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 about a quarter the number of malaria cases in infants.
“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 UN health agency, the Geneva-based WHO, has indicated it may recommend use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its license application.
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.
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 with immunization with a control vaccine.
The latest readout on Tuesday last week from the malaria trial, which is Africa’s largest-ever clinical trial involving almost 15,500 children in seven countries, were presented at a medical meeting in Durban, South Africa.
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.
Previous data sets released from earlier parts of the trial showed the vaccine’s efficacy was 65 percent in babies analyzed six months after vaccination and only about 50 percent in five-month to 17-month-olds.
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