The World Health Organization recommended that “rotavirus vaccination be included in all national immunization programmes in order to provide protection against a virus that is responsible for more than 500,000 diarrheal deaths and two million hospitalizations annually among children.” The new recommendation was made by the WHO’s Strategic Advisory Group of Experts (SAGE), and “extends an earlier recommendation made in 2005 on vaccination in the Americas and Europe, where clinical trials had demonstrated safety and efficacy in low and intermediate mortality populations.” WHO said new data from clinical trials which evaluated vaccine efficacy in countries with high child mortality led to the recommendation for global use of the vaccine. WHO said that the clinical trial, funded in part by GAVI and conducted by PATH, WHO, GlaxoSmithKline (GSK), and “research institutions in high-mortality, low-socioeconomic settings of South Africa and Malawi, found that rotavirus vaccine significantly reduced severe diarrhea episodes due to rotavirus.” The clinical trial investigators from Malawi and South Africa will present and publish their data on the GSK Rotarix vaccine later this summer. Clinical trial sites in Bangladesh and Vietnam—along with sites in Ghana, Mali, and Kenya—evaluated the performance of Merck’s rotavirus vaccine, RotaTeq, and data are expected in Fall 2009.
Dr. Tachi Yamada, President of the Global Health Program at the Bill & Melinda Gates Foundation, said, “This WHO recommendation clears the way for vaccines that will protect children in the developing world from one of the most deadly diseases they face. We need to act now to deliver vaccines to children in Africa and Asia, where most rotavirus deaths occur.” WHO noted that “while efficacy data from Asian countries are forthcoming, SAGE recommended rotavirus vaccines for all populations, including Asia, since available evidence indicates that efficacy data can be extrapolated to populations with similar mortality patterns, regardless of geographic location.”