GSK submits application for malaria vaccine candidate
The submission followed a specific procedure that allows the EMA to assess a vaccine candidate manufactured by a European Union member state for use outside of the EU. RTS,S is intended exclusively for the Plasmodium falciparum malaria, which is primarily found in sub-Saharan Africa, according to a GSK press release.
"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," Sophie Biernaux, the head of the malaria vaccine franchise at GSK, said.
There is currently no licensed vaccine available for the treatment of malaria. RTS,S is designed to prevent the parasite from infecting the liver, after which it would reenter the blood stream and infect red blood cells, leading to disease symptoms.
Phase III clinical trials of RTS,S was conducted at 13 research centers in eight African countries. More than 16,000 infants and young children were used in the trial.
The World Health Organization indicated that a policy recommendation on the vaccine, which is a review process that aids in the development of immunization schedules, could be possible by the end of 2015 if a positive opinion from the EMA is granted.