The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for GlaxoSmithKline’s malaria candidate vaccine MosquirixT, also known as RTS,S, in children aged 6 weeks to 17 months. Following this decision, the World Health Organization (WHO) will now formulate a policy recommendation on use of the vaccine in national immunization programs once approved by national regulatory authorities.

RTS,S, which was developed in partnership with the PATH Malaria Vaccine Initiative (MVI), is the first candidate vaccine for the prevention of malaria to reach this milestone. While other vaccines tackle viruses or bacteria, RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA). In 2013, there were an estimated 584,000 deaths from malaria with around 90% of these occurring in SSA, and 83% in children under the age of five in SSA.

GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around 5% t that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

GSK has invested more than $365 million to date and expects to invest a further $200 million to $250 million until development is completed. Between 2001 and the end of 2014, the MVI, supported by grants from Bill & Melinda Gates Foundation, invested more than $200 million to advance the RTS,S project.

Following the CHMP positive scientific opinion, two of the WHO's independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) will now jointly review the evidence base for RTS,S and make a joint policy recommendation for how it might be used alongside other tools to prevent malaria in the event the vaccine candidate is approved by national regulatory authorities in SSA. The WHO has indicated that such a policy recommendation may be possible by end of this year.

Following the WHO policy recommendation, GSK will also submit an application to the WHO for pre-qualification of RTS,S. WHO pre-qualification involves a scientific assessment of the quality, safety and efficacy of any new vaccine proposed for introduction in 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 countries in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin implementation of RTS,S through their universal immunization programs. 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 program supported by UNICEF.

Source: GlaxoSmithKline