After three decades spent in developing the malaria vaccine known as RTS,S, British drug manufacturing company, GlaxoSmithkline, GSK, is set to release it by 2015.
GSK is currently seeking regulatory approval for the world’s first malaria vaccine after trial data showed it had halved the number of cases in young children in Africa.
The findings of the malaria trial, Africa’s largest-ever, involving almost 15,500 children in seven countries, were presented at a medical meeting in Durban, South Africa.
“Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA),” GSK said in a statement.
GSK is developing the vaccine in partnership with the non-profit Path Malaria Vaccine (MVI) supported by funding from the Bill & Melinda Gates Foundation.
The statement also said the hope now is that the Geneva-based World Health Organization (WHO) may recommend the use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its licence application.
Testing showed that 18 months after vaccination, children aged five to 17 months had a 46% reduction in the risk of clinical malaria compared to unvaccinated contemporaries. But in infants aged six to 12 weeks at the time of vaccination, there was only a 27% reduction in risk.
“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,” Sir Andrew Witty, chief executive of GSK, said.
This, no doubt, is a significant progress in the fight to eradicate malaria, the leading cause of illness and death across the globe. Findings have shown that the parasitic disease, carried by mosquitoes, kills around 800,000 people every year and 90 per cent of all malaria cases are in sub-Saharan Africa.
“Many millions of malaria cases fill the wards of our hospitals,” said Halidou Tinto, a lead investigator on the RTS,S trial from Burkina Faso.
“Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.”
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