24th Jul 2014 10:28
LONDON (Alliance News) - GlaxoSmithKline PLC said Thursday it has submitted a regulatory application to the European Medicines Agency for its malaria vaccine candidate RTS,S.
The company said that the submission is the first step in the regulatory process towards making the vaccine available as an addition to existing tools for malaria prevention. There is no licensed vaccine available for the prevention of malaria.
If the EMA grants a positive opinion, the World Health Organisation has indicated that a policy recommendation may be possible by the end of 2015. A policy recommendation is a formal review process by WHO to assist in the development of optimal immunisation schedules for diseases with global public health impact like malaria.
It would also be the basis for marketing authorisation applications to National Regulatory Authorities in sub-Saharan countries, it 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," said Head of Glaxo's Malaria Vaccine Franchise Sophie Biernaux.
Shares in GlaxoSmithKline were trading down 0.6% at 1,472.00 pence Thursday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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