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The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.
GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. The submission follows the Article 58 procedure, in which EMA will assess the quality, safety, and efficacy of the vaccine, manufactured in a European Union (EU) member state, but intended exclusively for use outside the EU, for a disease recognized by the World Health Organization (WHO) as of major public health interest.
EMA and WHO will collaborate on the assessment of the vaccine. The product will be required to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the CHMP 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). It is estimated that malaria accounts for approximately 90% of deaths in SSA, of which 77% occur in children below the age of five.
The regulatory filing marks the first step in the approval process toward making RTS,S 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 an advance in malaria control. To-date, there is no licensed vaccine available for the prevention of malaria.
WHO has indicated that a policy recommendation (i.e., a formal review process designed to assist the development of optimal immunization schedules for diseases that have a global public health impact, such as malaria) may be possible by the end of 2015 if EMA grants a positive opinion.
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.
Data from the phase III vaccine trial program, conducted at 13 African research centers in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including more than 16,000 infants and young children have also been included to support the filing.