The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has, for the very first time, given the green light for a malaria candidate vaccine to be incorporated into national immunisation programmes.
The EMA adopted a “positive scientific opinion” for Mosquirixtm, developed by GlaxoSmithKline, and the World Health Organisation (WHO) will now formulate policy recommendations on the use of the vaccine once it gets approved by national regulatory authorities.
Mosquirixtm, or RTS,S, is the first candidate vaccine to receive such approval and works by preventing malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa.
The approval will not see the vaccine rolled out for children aged 6 weeks to 17 months, to arrest the damaging effect of the disease on children, with an estimated 83% of the 584,000 deaths in the region in 2013 in children under the age of 5.
A phase III clinical trial programme involved more than 16,000 young children across 8 African countries. Malaria cases were reduced by almost half in children aged 5-17 at the time of first vaccination. In areas of high incidence rates, more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated. Its efficacy was determined alongside the use of existing malaria controls, such as insecticide treated bed nets.
Sir Andrew Witty, CEO of GSK, said: “Today’s scientific opinion represents a further important step towards making available for young children the world’s first malaria vaccine. 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.”
Dr David C. Kaslow, Vice President of Product Development at PATH said: “Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite.”
Professor Adrian Hill of the Jenner Institute, Oxford, told the BBC: “A bed net is more effective than this vaccine, but nonetheless it is a very significant scientific achievement. I see it as a building block towards much more effective malaria vaccines in years to come.”