WHO convenes experts to provide guidance on extrapolating clinical trial data on rotavirus vaccines  

The October 24, 2008, issue of the Weekly Epidemiological Record (WER), published by the World Health Organization (WHO), features a report on the outcome of a meeting of global, regional, and country-level rotavirus experts and immunization opinion leaders who gathered to provide guidance on evaluating and extrapolating clinical trial data on rotavirus vaccines.

Participants agreed that even vaccines with moderate efficacy would bring about substantial public health benefits in developing countries in Africa and Asia, where most rotavirus deaths occur, and would be cost effective for saving children's lives. The experts noted that criteria such as the WHO mortality strata and local epidemiology of rotavirus infection are useful for extrapolating clinical trial data to other regions and countries.  The meeting participants also deliberated about the research agenda for candidate rotavirus vaccines under development.

The PATH Rotavirus Vaccine Program is collaborating with GlaxoSmithKline and Merck & Co., Inc., to generate important efficacy data through clinical trials in Bangladesh, Ghana, Kenya, Malawi, Mali, South Africa, and Vietnam. Interim results from the South Africa trial are positive and underscore the potential of rotavirus vaccines to have significant public health impact in low-resource countries. Additional data will be available soon, and results from all of the clinical studies in progress will be available in 2009.

The WER article, "Evaluating clinical trial data and guiding future research for rotavirus vaccines," may be read in full at http://www.who.int/wer/2008/wer8343.pdf.

 The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance.