European Union Agency Approves GSK’s Malaria Vaccine

Pharmaceuticals manufacturer GSK yesterday announced acceptance of their malaria vaccine for infants between six weeks and 17 months.

The EU Human Medicine Regulatory Agency accepted Glaxosmithkline’s vaccine Mosquirix, also known as RTSs.

GSK managing director Allan Pamba said clinical data submitted for CHMP assessment were mainly from a Phase III clinical trial programme involving more than 16,000 children.

Pamba said data from the trial programme demonstrated that over the first 18 months, malaria infections cases among children imunised with RTS reduced by more than half.

“Following three doses of RTS malaria cases were reduced by almost half in children aged five and seventeen months at the time of first vaccination and by 27 per cent in infants aged six to twelve weeks,” he said.

The trials were conducted by 13 African research centres in Kenya, Burkina Faso, Gabon, Ghana, Malawi, Mozambique, Nigeria, and Tanzania.

The MD said the decision allows the World Health Organization to formulate a policy recommendation on use of the vaccine in national immunisation programmes, once approved by respective national regulatory authorities.

The regimen developed in partnership with the Malaria Vaccine Initiative is the first candidate vaccine to be accepted for the prevention of malaria.