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UK firm seeks to market world's first malaria vaccine | UK firm seeks to market world's first malaria vaccine |
(about 5 hours later) | |
British drug maker GlaxoSmithKline is seeking regulatory approval for the world's first malaria vaccine after trial data showed that it had cut the number of cases in African children. | British drug maker GlaxoSmithKline is seeking regulatory approval for the world's first malaria vaccine after trial data showed that it had cut the number of cases in African children. |
Experts say that they are optimistic about the possibility of the world's first vaccine after the trial results. | Experts say that they are optimistic about the possibility of the world's first vaccine after the trial results. |
Malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people worldwide every year. | Malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people worldwide every year. |
Scientists say an effective vaccine is key to attempts to eradicate it. | Scientists say an effective vaccine is key to attempts to eradicate it. |
The vaccine known as RTS,S was found to have almost halved the number of malaria cases in young children in the trial and to have reduced by about 25% the number of malaria cases in infants. | The vaccine known as RTS,S was found to have almost halved the number of malaria cases in young children in the trial and to have reduced by about 25% the number of malaria cases in infants. |
GlaxoSmithKline (GSK) is developing RTS,S with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation. | GlaxoSmithKline (GSK) is developing RTS,S with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation. |
"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. | "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." | "Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease." |
The malaria trial was Africa's largest-ever clinical trial involving almost 15,500 children in seven countries. | The malaria trial was Africa's largest-ever clinical trial involving almost 15,500 children in seven countries. |
The findings were presented at a medical meeting in Durban, South Africa. | The findings 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. | "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. |
The company has been developing the vaccine for three decades. | The company has been developing the vaccine for three decades. |
The statement said that 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. | The statement said that 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. | 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. | But in infants aged six to 12 weeks at the time of vaccination, there was only a 27% reduction in risk. |
A spokeswoman for GSK told the AFP news agency that the company would file its application to the EMA under a process aimed at facilitating new drugs for poorer countries. | A spokeswoman for GSK told the AFP news agency that the company would file its application to the EMA under a process aimed at facilitating new drugs for poorer countries. |
UK politician Lynne Featherstone, International Development Minister, said: "Malaria is not just one of the world's biggest killers of children, it also burdens health systems, hinders children's development and puts a brake on economic growth. An effective malaria vaccine would have an enormous impact on the developing world. | |
"We welcome the scientific progress made by this research and look forward to seeing the full results in due course." |