Global drug maker Glaxo SmithKline has submitted its first regulatory application to the European Medicines Agency (EMA) for the assessment of the RTS,S vaccine.

EMA will do the assessment in collaboration with the World Health Organisation.

RTS,S, the only advanced malaria vaccine at its final study trials, is intended for exclusive use against the plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa.

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Around 90 per cent of estimated deaths from malaria occur in sub-Saharan Africa, and 77 per cent of these are in children under the age of five.

In East Africa, some 16 million to 18 million malaria cases are reported every year, and more than 300,000 deaths occur.

In the event of a positive outcome from the EMA, the WHO said a policy recommendation may be possible by the end of 2015.

The recommendation is a formal review process by WHO designed to assist in the development of optimal immunisation schedules for diseases such as malaria that have a global public health impact.

An approval for RTS,S would also be the basis for marketing authorisation applications to national regulatory authorities in sub-Saharan African countries.

If positive, these regulatory decisions will pave the way for the large-scale implementation of the vaccine through African national immunisation programmes.

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.