MALARIA: Could malaria vaccine “sit on the shelf”?

13 Dec 2010 : Paul Chinnock
By the year 2015, the first vaccine against malaria could be ready for use on a wide scale. But concerns have been expressed that inadequate planning could prevent it reaching those who are most in need of protection against the disease.
Of several potential malaria vaccines under investigation, the RTS,S vaccine is at the most advanced stage. Its history dates back to research conducted by GlaxoSmithKline and the Walter Reed Army Institute of Research in the mid-1980s. The first human trials began a decade later. A partnership between GSK and the non-profit PATH Malaria Vaccine Initiative (MVI) has made possible its further development.
Phase 3 clinical trials in sub-Saharan Africa began in 2009. Eleven sites in seven countries will enrol a total of 16,000 infants and children. Steps have been taken to expedite the rapid approval of the vaccine by African regulatory authorities, as well as by officials at WHO and the European Medicines Agency, assuming that the trials confirm the effectiveness and safety of RTS,S. It is hoped that this will lead on to the vaccine entering general use as early as 2015.
The level of effectiveness of the vaccine will not be clear until the Phase 3 trials have been completed. It is already apparent that it will not be as effective as vaccines for many other diseases, but a Phase 2 trial in Tanzania [1] found that RTS,S reduced the risk of Plasmodium falciparum infection by 65% and this degree of effectiveness (or even lower) could still save many lives each year. Malaria control programmes would use the vaccine in combination with other tools – residual insecticide spraying of houses, long-acting insecticide-treated bednets, rapid diagnostic tests, and treatment using artemisinin combination therapy.
But the fear of many malaria specialists is that, once the vaccine is ready, health systems in malaria-endemic countries may not be able to bring it into use, because of inadequate preparation. “After decades of research and tens of millions of dollars invested … it would be scandalous if this vaccine just sits on the shelf,” said Yvette Collymore of MVI speaking at a recent conference in Washington DC, USA.
The concern expressed by MVI raises a wider issue. In recent years – with new funding, from sources such as the Gates Foundation and the establishment of a number of public–private product development partnerships – we have seen more R&D efforts targeted on the infectious diseases of poverty. An encouraging number of new tools are now in the development pipeline. But R&D is only the beginning. It will be essential that systems are in place to put the new tools to work and make them available to all those who need them.

Reference
Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F et al. (2008). Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med; 359(24):2533-2544. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19064623

http://www.tropika.net/svc/news/20101213/Chinnock-20101213-News-RTSS