LONDON // A British drugmaker will 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 around 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),” GlaxoSmithKline, which has been developing the vaccine for three decades, said on Tuesday.
It added that the United Nations health agency, the Geneva-based World Health Organisation (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.
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.
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.
Data released earlier this year found RTS, S’s effectiveness wanes over time, with the shot protecting only 16.8 per cent of children over four years.
Nonetheless, David Kaslow, vice president of product development at PATH, said RTS, S would serve as a useful additional tool alongside other malaria control measures such as mosquito nets, insecticides and anti-malaria drugs.
Reuters
