The world’s first malaria vaccine has been approved by the European Medicines Agency (EMA), setting the stage for a final assessment by the World Health Organisation (WHO) before the drug can be accepted by countries ravaged by the disease.
GlaxoSmithKline, the pharmaceutical company behind the drug Mosquirix, announced the approval by regulators last week, indicating that the European assessors had adopted a positive scientific opinion for its use in children aged six weeks to 17 months.
The drug, also known as RTS,S, was co-developed with the PATH Malaria Vaccine Initiative, and prevents malaria caused by the Plasmodium alciparum parasite. Global anticipation for the vaccine is immense, with despairing statistics highlighting how much of a problem malaria still is in the developing world.
Figures from 2013 indicate that the disease claims a child every single minute, with an estimated overall death toll that year of 584,000 people. The disease is prevalent in tropical and subtropical regions, with sub-Saharan Africa as the worst affected area: of the 584,000 deaths in 2013, 90 percent occurred in the region, with 83 percent in children under the age of five.
“Today’s scientific opinion represents a further important step towards making available for young children the world’s first malaria vaccine,” said Sir Andrew Witty, CEO of GlaxoSmithKline, in a statement. “While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most.”
Having been approved by the EMA, the drug will now be reviewed by independent advisory groups on behalf of the WHO, to devise recommendations on how it could be used alongside other medicines to help prevent the disease in countries where it is approved for use by national regulators. It’s believed that the WHO’s recommendations may be announced this year, but the national processes involving specific sub-Saharan countries will take additional time to be resolved. It’s hoped the vaccine will become available within the next few years.