GlaxoSmithKline announced on Thursday it is applying to the European Medicines Agency (EMA) for approval of its new malaria vaccine candidate, called RTS,S. Specifically created for children in Africa, the vaccine will be evaluated by the World Health Organization (WHO) in collaboration with the EMA.
Malaria is a parasitic disease that is transmitted to people through the bites of infected mosquitoes. It kills a child every minute, with 90 percent of the world’s malaria deaths occurring in Africa. RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa.
The British drugmaker said its scientists have been working on the vaccine for over 30 years. GSK stated the price of RTS,S, once approved, will cover the cost of manufacturing with a small return of around five percent to be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.
While GSK finds its malaria vaccine candidate to provide young African children with “significant protection” against malaria, analysts and observers felt somewhat disappointed with the results of clinical trials conducted at 11 trial sites in seven countries across sub-Saharan Africa. Data showed three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56 percent and 47 percent, respectively. To support the application, the drugmaker has included data from additional final-stage trials conducted at 13 African research centers in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania.
During the experimental trials, RTS,S was administered in three doses, one month apart. RTS,S aims to trigger a person’s immune system to defend itself when the P. falciparum malaria parasite first enters the bloodstream or when the parasite begins to infect liver cells. GSK designed the vaccine to prevent the parasite from infecting, maturing, and multiplying in the liver. It is intended to work as a preemptive strike against the parasite and stop it from re-entering the bloodstream and infecting red blood cells, which is the moment when disease symptoms begin.
GSK has invested more than $350 million to date in the vaccine and expects to invest a further $260 million. More than $200 million in grants have been provided by the Bill & Melinda Gates Foundation, while the PATH Malaria Vaccine Initiative has also contributed financial, scientific, managerial, and field expertise to the development of RTS,S. If EMA approves of the vaccine, WHO said a policy recommendation may be possible by the end of 2015. Such a recommendation assists in the development of immunization schedules for diseases, such as malaria, that have a global public health impact.