The filing of the application will follow the Article 58 procedure, which enables the EMA to evaluate the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a EU member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU.
The evaluation carried out by the EMA in collaboration with the WHO requires products to meet the same standards as vaccines or medicines intended for use in the EU.
The CHMP has granted eligibility for the ‘application’ after agreement from WHO that RTS,S met criteria for such an evaluation.
RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA).
About 90% of estimated deaths from malaria occur in SSA, and 77% of these are in children under the age of five.
According to the company, if EMA grants a positive opinion, the WHO has indicated a policy recommendation may be possible by end of 2015.
The EMA positive opinion would also be the basis for marketing authorization applications to National Regulatory Authorities (NRAs) in SSA countries.
GSK Malaria Vaccine Franchise head Sophie Biernaux said: "This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria."
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton