The world’s first malaria vaccine— RTS,S created by pharma company GSK, is expected to hit the markets by 2015. GSK has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.
Application of RTS,S:
The vaccine will be uses exclusively against the Plasmodium falciparum malaria parasite, which is widespread in Sub-Saharan Africa (SSA). As per estimates, around 90% deaths from malaria occur in SSA, and 77% of these are in children under the age of 5.
To support the efficacy of the vaccine, 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 the filing. 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 reported 46% fewer cases of clinical malaria, compared to children immunised with a placebo.
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. Malaria hospitalisations came down by 42%.
How RTS,S works?
The vaccine triggers the body’s immune system to protect 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 developed 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.
GSK has pledged to sell the vaccine at cost price plus 5%, which it said would finance further research into tropical diseases. Now EMA will evaluate the vaccine as per Article 58 procedure, which allows the body 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 Organisation as of major public health interest, but intended exclusively for use outside the EU.
This assessment is conducted by the EMA in collaboration with the WHO, and necessitates products to meet the same benchmarks as vaccines or medicines intended for use in the EU. As per WHO, if the EMA approves the vaccine, a policy recommendation may be possible by end of 2015. A positive opinion from the EMA would also be the basis for marketing authoritization applications to National Regulatory Authorities (NRAs) in SSA nations.