World's first malaria vaccine close to final approval
Xinhua, July 25, 2015 Adjust font size:
European regulators has given green light to Mosquirix, GlaxoSmithKline's (GSK) malaria candidate vaccine, bringing it closer to final approval for the prevention of malaria in young children in sub-Saharan Africa, GSK announced on Friday.
The European Medicines Agency "has adopted a positive scientific opinion" for Mosquirix, also known as RTS,S, in children aged 6 weeks to 17 months, according to GSK, a multinational pharmaceutical company headquartered in the UK.
Following this decision, the World Health Organization would assess and decide whether to recommend the use of the vaccine later this year, the company said.
Today's scientific opinion "represents a further important step towards making available for young children the world's first malaria vaccine," said Andrew Witty, CEO of GSK.
There were an estimated 198 million cases of malaria worldwide in 2013, and an estimated 584,000 deaths, and 90 percent of these deaths occurred in Africa.
Mosquirix is the first vaccine against a parasitic infection in humans, the research of which GSK started 30 years ago. The first trials in Africa was conducted in 1998. The project received funding from the Bill and Melinda Gates Foundation.
The phase III clinical trial of the vaccine was conducted in eight African countries, involving more than 16,000 young children, the company said.
At study end, four doses of Mosquirix reduced malaria cases by 39 percent over four years of follow-up in children, and by 27 percent over three years of follow-up in infants, according to GSK. GSK has committed to a not-for-profit price for the vaccine.
"The work doesn't stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease," said Andrew Witty. Endit