Malaria vaccine may be on the way to approval

WHO pre-qualification involves a scientific assessment of the quality, safety, and efficacy of any new vaccine proposed for introduction in the WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large-scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorization in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin using RTS,S through their universal immunization program.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunization programs supported by UNICEF.

GSK has committed to a not-for-profit price for RTS,S. If the vaccine is approved, the price would cover the cost of

manufacturing RTS,S and a return of around 5% to be reinvested in

research and development for second-generation malaria vaccines or

vaccines against other neglected tropical diseases.