Global healthcare company GlaxoSmithKline announced on Thursday that they are seeking approval for the world's first vaccine against malaria that is designed for children in Africa. The mosquito-borne illness affected over 207 million people worldwide in 2012.
The vaccine, RTS,S, would be given as a shot and will be evaluated by the European Medicines Agency (EMA) as well as the World Health Organization (WHO). If approved, it will be used exclusively outside of the European Union and will help prevent the deaths of hundreds of thousands of babies each year in sub-Saharan Africa. Malaria claims the lives of 600,000 people each year.
The quality and safety of the immunization will be determined by the EMA and WHO, but they already have some data on its effectiveness. A final-stage trial revealed that the vaccine only provided modest protection in babies aged six to 12 weeks, which has ruled out the possibility of wiping out Malaria, but it will still help save a number of lives as most of the fatalities from malaria consist of babies and young children. GlaxoSmithKline conducted trials at 13 African research centers to arrive at their results.
"This is a key moment in GSK's 30-year journey to develop RTS,S and brings us a step closer to making available the world's first vaccine that can help protect children in Africa from malaria," said Dr. Sophie Biernaux, Head of the Malaria Vaccine Foundation, GSK, in a company news release.
"An effective vaccine for use alongside other measures such as bed nets and anti-malarial medicines would represent an advance in malaria control," the company added.
According to GSK, the WHO indicated a policy recommendation may be possible for the vaccine by the end of 2015 if the EMA issues a positive opinion after review. Additionally, the company could be permitted to submit marketing authorization applications to National Regulatory Authorities in sub-Saharan African counties. If approved, GSK said RTS,S would be priced at cost of manufacture plus a 5% margin, with the margin being reinvested in research for malaria and other tropical diseases that affect underdeveloped nations across the world.
You can read more about GSK's malaria vaccine in this Reuters news article.
