MSF response on WHO guidance on malaria vaccine RTS,S

The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) committee has recommended continued research on the RTS,S malaria vaccine through some well-monitored demonstration sites.
Given the current characteristics of the vaccine regarding its efficacy, safety concerns and therefore very limited conditions for use, MSF will not roll out the RTS,S vaccine.
Even in optimal clinical trial conditions where children have received the full vaccination schedule, the conferred protection of the malaria vaccine—especially against the severe form of malaria— has been shown to be too limited to justify any roll-out. Moreover, side effects still have to be better understood, and it has to be determined whether the potential benefits outweigh the potential harm.
The vast majority of areas with high malaria transmission are located in places with low basic childhood vaccination rates and weak health systems, which precludes a successful introduction of the RTS,S vaccine outside a controlled research setting. When a child cannot receive the four doses at the appropriate ages, the protection is extremely low.
Although finally having a malaria vaccine could be considered as a good start, much more research is needed to have an improved product with conditions for use that match those in the areas where it is most needed.
MSF responds with the following quote:

“Considering the RTS,S malaria vaccine is at best effective about one third of the time, and requires four doses, we think that WHO has made a rational recommendation based on the evidence available for the vaccine’s limited use, but urges caution and close monitoring.

“Most areas with a high burden of malaria cases are in low-resource settings with weak health systems, so the successful introduction of RTS,S in these areas would  be extremely challenging, requiring intensive resourcing better placed on scaling up existing malaria treatment and prevention activities.

“While we commend the researchers for developing the first malaria vaccine candidate to be tested in a large scale clinical trial, RTS,S ultimately does not meet the criteria needed to provide adequate protection for those who need it most. We now need to accelerate investment and development of new malaria vaccines that are safe, effective, affordable and easy-to-use in the highest-burden areas.”  

- Dr. Micaela Serafini, Medical Director, MSF Operational Center Geneva



Page updated: 23 October 2015
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Lives on the edge - patient needs are not driving medical research and development, and the result is millions of lives on the edge.