From iAfrica, writer Janine Erasmus fills us in on the drug's progress.
GlaxoSmithKline's (GSK) RTS,S malaria vaccine has entered phase three of its clinical trial. This is the critical proof-of-concept stage and if it succeeds, the drug could be on the market by 2012.
Viewed as the most advanced malaria vaccine available, the RTS,S vaccine passed its initial tests with flying colours.
The results of the earlier studies were published in the December 2008 edition of the New England Journal of Medicine. Experts subsequently recommended that studies be advanced to the next stage.
This is significant because few vaccines manage to meet the rigorous standards of a full clinical trial, which may take up to 12 years. For any drug to make it this far shows that it is very promising indeed, and RTS,S is the first malaria candidate to do so.
Could be ready for 2012
Should phase three trials be successful, the manufacturer is hoping to apply for regulatory approval in 2011 to begin marketing the drug by 2012.
To date, GSK has invested over $300-million (R3-billion) in getting RTS,S to this stage since the drug's initial discovery in 1981. The pharmaceutical giant received funding for further development in 2001, from the non-profit PATH Malaria Vaccine Initiative. This initiative was born out of a grant to PATH — the Programme for Appropriate Technology in Health — by the Bill & Melinda Gates Foundation.
The Malaria Vaccine Initiative is also striving to ensure that RTS,S is accessible to those who need it most, and has entered into talks with other organisations to see how the price can be kept as low as possible.
The organisation's director Christian Loucq said emphatically that the cost to African babies and mothers would be zero.
GSK has stated that the development of an effective malaria vaccine, especially for women and children, is one of its primary goals. The disease kills close on one-million people every year. Of these, 90 percent live in sub-Saharan Africa, and most are children under the age of five.