GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.

The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety, and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognized by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU. This assessment is done by the EMA in collaboration with the WHO and requires products to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the Committee for Medicinal Products for Human Use after agreement from WHO that RTS,S met criteria for such an evaluation.

RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90% of estimated deaths from malaria occur in SSA, and 77% of these are in children under the age of five

The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. An effective vaccine for use alongside other measures such as bednets and anti-malarial medicines would represent a advance in malaria control. To-date there is no licensed vaccine available for the prevention of malaria.

If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015. A policy recommendation is a formal review process by WHO designed to assist in the development of optimal immunization schedules for diseases that have a global public health impact, such as malaria.

A positive opinion from the EMA would also be the basis for marketing authorization applications to National Regulatory Authorities (NRAs) in SSA countries. A review by a European medicines agency is required by the majority of African countries prior to registration of a medicinal product manufactured in Europe. If positive, these regulatory decisions would help pave the way toward the large-scale implementation of the vaccine through African national immunization programs.

GSK has taken the lead in the overall development of RTS,S and has invested more than $350 million to date and expects to invest a further $260 million until development is completed. With more than $200 million in grant monies from the Bill & Melinda Gates Foundation, the PATH Malaria Vaccine Initiative contributes financial, scientific, managerial, and field expertise to the development of RTS,S.

GSK has committed that the eventual price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Source: GlaxoSmithKline