March 16, 2010

Merck’s RotaTeq® vaccine earns WHO prequalification for worldwide use

Last week, the World Health Organization (WHO) granted global prequalification to the RotaTeq® vaccine manufactured by Merck & Co., Inc. This status allows for procurement by United Nations’ agencies for use in national vaccination programs worldwide. The decision by WHO is based on unprecedented data from clinical studies of RotaTeq® in developing countries in Africa and Asia.

In October 2008, RotaTeq® was prequalified for use in regions where clinical trial data showed safety and efficacy. Only after the conclusion of clinical trials in Africa and Asia could WHO review safety and efficacy data to determine whether the vaccine was appropriate for use in the regions of the world where rotavirus burden is greatest. The studies, completed in late 2009, were the result of a partnership including PATH, WHO, the US Centers for Disease Control and Prevention, Merck, and clinical trial investigators at research sites in high-mortality, low-socioeconomic settings of Ghana, Kenya, Mali, Bangladesh, and Vietnam. WHO has reviewed data, and complete results will be published later this year. The Rotarix^TM vaccine, manufactured by GlaxoSmithKline, is also prequalified for global use.

The PATH Rotavirus Vaccine Trials Partnership is a collaboration between PATH, WHO, the US CDC, clinical study sites, and vaccine manufacturers. The partnership’s activities are funded by the GAVI Alliance.