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Malaria experts welcome green light for RTS,S vaccine

Researchers from the London School of Hygiene & Tropical Medicine have welcomed today's announcement that the European Medicines Agency has given the go-ahead for the RTS,S vaccine.

The regulatory approval marks a significant milestone in efforts to reduce the number of cases of the killer disease in Africa and elsewhere.

The School has been involved in research on the RTS,S malaria vaccine for many years.

Professor David Schellenberg, Professor of Malaria and International Health at the School, said: "The road to a licensed malaria vaccine has been very long. We frequently hear of 'breakthroughs' in the vaccine development but the evaluation course is long and complicated and many high hopes are followed by disappointments as potential vaccines fail safety or efficacy tests. The European Medicines Agency's approval of RTS,S is a true milestone: for the first time we have a malaria vaccine approved to help reduce the intolerable burden of malaria.

"Major gains have been made in malaria control over the last 15 years by the imperfect delivery of imperfect tools. The licensure of RTS,S comes at a key moment, when insecticide and drug resistance threaten the cornerstones of malaria prevention and treatment. Although RTS,S has only partial efficacy it can clearly contribute to further major gains in malaria control if used judiciously. Now WHO and the National Malaria Control Programmes of malarious countries need to work out where and how to deliver the vaccine to unlock its true potential.

"A huge number of people and organisations have been involved in the development of this vaccine. The commitment of GlaxoSmithKline is admirable, pursuing the development of a product for some of the most impoverished countries in the world and therefore unlikely to make a real profit; the Bill and Melinda Gates Foundation which enabled the process through substantial funding through the Malaria Vaccine Initiative at PATH; the clinical research centres in Africa and their collaborative partners in Europe and the US; and the many study participants whose co-operation with the researchers has paid off and made the world's first malaria vaccine a reality."

Professor Sir Brian Greenwood, Professor of Clinical Tropical Medicine at the School, said: "Approval by the European Medical Agency of the RTS,S malaria vaccine is an important step forward in efforts to control malaria, which is still responsible for approximately half a million deaths a year despite increasing deployment of existing tools such as insecticide treated bednets and treatment of clinical cases of malaria with artemisinin based combination therapies. New tools for malaria control are needed. RTS,S is the first vaccine against a  parasite of man to achieve this recognition and this is, therefore, an important landmark. 

"RTS,S is an imperfect vaccine, providing only partial protection against clinical malaria, but it  has the potential to help in the control of malaria in areas where existing control measures are not effective enough. With approval by the EMA, WHO and national malaria control programmes in endemic areas will now be in a position to review whether RTS,S could contribute to their national malaria control programme and, if so, how the vaccine could be deployed to maximum effect.

"As a scientist who has been involved in research on RTS,S since the first clinical trial of the vaccines conducted in The Gambia in 1998, I am delighted that the many years of work undertaken by scientists in Africa and across the globe has led to its approval by the EMA and opened up the opportunity to find out how best we can use this vaccine to further enhance the success in control of malaria that has been achieved during the past decade."

RTS,S is being developed through a partnership led by GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative with support from the Bill and Melinda Gates Foundation.