The world's first malaria vaccine today cleared one of the final hurdles as it received a positive scientific opinion from European regulators and now awaits approval from the WHO before it could be administered within the next few years across Africa.
The vaccine, named Mosquirix, was given the green light by London-based European Medicines Agency after more than 30 years of research, detailed in 230,000 pages of data.
The vaccine will be examined by the WHO which will give its recommendation in November this year, and if approved, could be administered to children across Africa within the next few years.
"This is the first time ever that a malaria vaccine has got to the point of being reviewed by a regulatory authority. So this is a big step forward and we welcome the positive opinion given by the European Medicines Agency (EMA). This is an opinion and not a regulatory approval," said Gregory Hartl, WHO's spokesperson for Avian Influenza and other epidemic diseases.
"What happens next is that the assessment from EMA will be reviewed by WHO in October and we will look at the vaccine from the point of view of public health," Hartl said in Geneva.
The WHO said the vaccine will be reviewed for feasibility in field situations in developing countries, its affordability and its cost effectiveness.
"It's massively significant," said Allan Pamba, vice president for pharmaceuticals in East Africa for GlaxoSmithKline (GSK), which has spent more than USD 356 million to date on finding a vaccine.
Researchers and pharmaceutical companies have been trying to develop malaria vaccines for decades. Some vaccines which had been developed in the past failed in their phase three trials.
"It is a big development but it's not finished yet and certainly our work starts now," said Hartl.
Malaria kills around 600,000 people a year worldwide, most of them children under five in sub-Saharan Africa.