GlaxoSmithKline’s malaria candidate vaccine Mosquirix, which has been nearly 30 years in the making, has won a positive opinion from European regulators for the prevention of malaria in young children in sub-Saharan Africa.
The jab, which is also known as RTS,S and was developed in partnership with the PATH Malaria Vaccine Initiative, is targeted towards children aged six weeks to 17 months, and is the first candidate vaccine for the prevention of the parasitic infection to reach this milestone.
The recommendation by the Committee for Medicinal Products for Human Use was based on a clinical trial programme involving more tun 16,000 children, which showed that malaria cases were reduced by almost half in children aged five-17 months at the time of first vaccination and by 27% in infants aged six-12 weeks.
But three doses were needed and efficacy dimmed over time, which has led some to question whether the cost of rolling out the vaccine can be justified. Others argue that its level of efficacy can still make a huge difference in a region that sees around more than half a million deaths a year from the disease.
“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,” said Sir Andrew Witty, GSKs chief executive.
WHO recommendation by year-end
The World Health Organisation will now jointly review the evidence base and to create a policy recommendation on the adoption of Mosquirix, and how it might be used alongside other tools to prevent malaria if approved by national regulatory authorities in SSA.
The intended price for Mosquirix has not yet been revealed but GSK says it will not make a profit from the vaccine. The jab will be merely priced to cover the cost of manufacturing as well as a small return of around 5% which is to be reinvested in research and development for second-generation malaria vaccines or those against other neglected tropical diseases.