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UK firm to seek approval for malaria vaccine

Drug maker GSK eyes regulatory approval for prototype vaccine after trials show it offers partial shield for infants.

Last Modified: 08 Oct 2013 22:30
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The British drug maker GlaxoSmithKline (GSK) said it hoped to get the green light for a prototype vaccine against malaria after trials showed it offered children a partial shield against the disease.

Results for the Phase III stage of the closely-followed RTS,S vaccine were unveiled on Tuesday at a conference in Durban, South Africa, gathering experts on malaria in Africa.

It showed that 18 months after vaccination, children aged five to 17 months had a 46-percent reduction in the risk of clinical malaria compared to unvaccinated peers.

But in infants aged six to 12 weeks at the time of vaccination, efficacy was lower: a 27-percent reduction in risk.

A spokeswoman for GSK told AFP news agency that the company would file an application to the European Medicines Agency (EMA) under a process aimed at facilitating new drugs for poorer countries.

'Scientific opinion'

Under that process, the European medications watchdog gives a "scientific opinion" on the safety and efficacy of the vaccine.

This opens the way for the vaccine to be considered by the World Health Organisation (WHO), which in turn can fast-track its licensing in individual countries in Africa.

"We will submit, in 2014, an application for a scientific opinion by the Committee for Medicinal Products for Human Use on RTS,S through the EMA Article 58 procedure," the GSK spokeswoman said.

"The intent is not to make the vaccine available in the EU as it is being developed specifically for children in sub-Saharan Africa who are most at risk of malaria."

RTS,S is a frontrunner in the race to develop the first vaccine for malaria, which according to WHO figures for 2010 - the latest estimates available - infected about 220 million people, killing 660,000 of them.

The toll is highest among small children in Africa.

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