The world's first malaria vaccine will be available in the market by next year.
Pharma company GSK has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.
RTS,S will be exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA).
Around 90% of estimated deaths from malaria occur in SSA, and 77% of these are in children under the age of 5.
Data from the phase III vaccine trial programme conducted at 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also been included to support the filing.
Results from a large-scale Phase III trial showed that over 18 months of follow-up, children aged 5-17 months at first vaccination with RTS,S experienced 46% fewer cases of clinical malaria, compared to children immunized with a control vaccine.
An average of 941 cases of clinical malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated in this age group.
Severe malaria cases were reduced by 36%; 21 cases of severe malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated.
Malaria hospitalizations were reduced by 42%.
RTS,S aims to trigger the body's immune system to defend against the P falciparum malaria parasite when it first enters the human host's bloodstream and/or when the parasite infects liver cells. The vaccine is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms. In the phase III efficacy trial, RTS,S was administered in three doses, one month apart.
Trials showed that the vaccine effectively protected young children and infants from clinical malaria up to 18 months after vaccination.
GSK said "Over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination)".
GSK has vowed to sell the vaccine at cost price plus 5%, which it said would fund further research into tropical diseases. The new results are from a study of 15,000 babies and children in seven African countries.
The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization as of major public health interest, but intended exclusively for use outside the EU.
This assessment is done by the EMA in collaboration with the WHO, and requires products to meet the same standards as vaccines or medicines intended for use in the EU.
The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. To-date there is no licensed vaccine available for the prevention of malaria.
If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015.
A positive opinion from the EMA would also be the basis for marketing authorisation applications to National Regulatory Authorities (NRAs) in SSA countries.
Dr Sophie Biernaux, head of the Malaria Vaccine Franchise, GSK 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".
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