Giant drug-maker GlaxoSmithKline is seeking regulatory approval for RTS,S, 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.
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.
RTS,S (or Mosquirix ) 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.
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.
“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 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.
GSK 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.
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.
However, 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.
Malaria:
- Malaria remains the leading cause of illness and death around the globe
- Worldwide, a child dies of malaria every 30 seconds
- The parasitic disease, carried by mosquitoes, kills around 800,000 people a year
- 90% of all malaria cases are in sub-Saharan Africa
- Making malaria vaccine available for routine use will be a major hallmark
- The vaccine will only be part of the solution to tackling this preventable infection
- Bed nets, insect repellents, malaria drugs and targeted killing of mosquito breeding grounds are also key, say experts [youtube J6r9UIWGvW4]
