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The European Medicines Agency has delivered a positive opinion on a malaria vaccine for use outside of the European Union in babies.
Dr Jake Baum, Department of Life Sciences, Imperial College London, said:
“We shouldn’t shy away from celebrating today’s news. There may be many caveats to the vaccine, how well it will work and what its impact will be. However, there is a lot to be excited about with the possibility of a malaria vaccine being licensed. Not least because this would be the first vaccine against a parasitic disease licensed for human use. Compared to bacteria and viruses, the malaria parasite is extremely complicated – something that has hampered our best efforts to develop a vaccine – so if it works, even moderately, that really is a triumph!
“The reality of malaria disease is enormous. An estimated 600,000 children die each year, and with the rise and spread of resistance to our frontline anti-malarial drugs and growing spectre of insecticide resistance we need more in our armoury to stop the transmission of the parasite and treat the disease. The vaccine is no magic bullet – alone its impact may not be as great as the expectations we may have had for it. But in combination with continued bed-net roll out and new improved drugs, this vaccine certainly has the potential to improve the situation for those most at risk of serious disease.
“The new vaccine will be one more weapon in the arsenal against malaria; the vaccine is not expected to solve the problem of malaria in its own. Along with existing interventions – including anti-malarial drugs, bed nets and insecticides – this vaccine will contribute to reducing deaths from malaria.”
Prof. Sir Brian Greenwood, Professor of Clinical Tropical Medicine, London School of Hygiene & Tropical Medicine, 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.”
Prof. David Schellenberg, Professor of Malaria and International Health, London School of Hygiene & Tropical Medicine, 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.”
Declared interests
Dr Jake Baum: Active grants that include GSK or BMGF:
Bill and Melinda Gates Foundation (2015). J. Baum (PI), M. Delves (Lead) OPP1043501. Development & evaluation of high throughput assays assessing mature gametocyte functional viability in P. falciparum. March 2015 to March 2017. Value US$1,271,954. Jointly held with GSK (funded by Gates).
Wellcome Trust Pathfinder Award (2015). J Baum (CIA) L Ballell GSK (CIB) Development of an industry standard, high-throughput translation-inhibition discovery platform for the malaria parasite. February 2015 to August 2016. Value £108,073. Jointly held with GSK (funded by Wellcome).
Prof. Sir Brian Greenwood: The London school of Hygiene & Tropical Medicine has received financial support from PATH to assist with the evaluation of the RTS,S vaccine in Africa. Brian Greenwood reports no other conflict of interest.
Prof. David Schellenberg has supported the Malaria Vaccine Initiative in the clinical evaluation of RTS,S.