Merck's RotaTeq® vaccine earns WHO prequalification

WHO has placed RotaTeq®, the rotavirus vaccine manufactured by Merck & Co., on its list of prequalified vaccines for purchase by UN agencies as of October 2008. WHO's prequalification of RotaTeq® is a major step in accelerating the availability of rotavirus vaccines in the developing world. The Rotarix® vaccine manufactured by GlaxoSmithKline (GSK) achieved prequalification in January 2007.

"Vaccines are the best hope for preventing severe rotavirus disease," said John Wecker, PhD, Director of the PATH Rotavirus Vaccine Program (RVP). "WHO's prequalification of RotaTeq® is an important milestone towards ensuring that rotavirus vaccines are accessible to children worldwide."

RVP is collaborating with Merck and GSK to generate important efficacy and safety data through clinical trials in South Africa, Malawi, Ghana, Mali, and Kenya in Africa, and Bangladesh and Vietnam in Asia. Data from clinical studies currently in progress will become available in 2009.

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