Since 2006, ROTATEQ has been registered and approved in more than 100 countries, with more than 71 million doses distributed worldwide. In 2012, Rwanda will become the first African country to introduce ROTATEQ through a national immunization program, and represents a new GAVI-eligible country to introduce the vaccine.
In 2006, Merck introduced ROTATEQ in Nicaragua through a joint program with the Nicaraguan Health Ministry. This initiative marked the first time there was access to a vaccine in the public sector of a developing country in the same year that it was first licensed in a developed country. This program completed in 2009 and achieved an estimated 94 percent vaccine coverage (percent receiving third dose of ROTATEQ) among Nicaraguan infants. In March 2010, the immunization program was transitioned to GAVI funding. The significant public health impact of the introduction and widespread use of ROTATEQ in this program was demonstrated through a case-control study of the effectiveness of vaccination. Over a two year period, three doses of Merck's rotavirus vaccine reduced the risk of hospitalization or emergency department visits for severe rotavirus disease by 76 percent for community and hospital visits combined. The vaccine also demonstrated high vaccine effectiveness (87 percent) against severe disease among children younger than 12 months of age at the time of onset of acute disease.1 Learn more about the joint program in Nicaragua.
In 2009, Merck, in partnership with PATH and other organizations also completed clinical trials evaluating the safety and efficacy of ROTATEQ in Bangladesh, Ghana, Kenya, Mali and Vietnam. Trials at all sites in Africa and Asia involved more than 7,500 infants, and the data were published in the August 2010 issue of The Lancet.2
International organizations such as WHO, GAVI and the Gates Foundation have recognized the importance of rotavirus vaccination. The Strategic Advisory Group of Experts, the principle advisory group to the WHO for vaccines and immunization, has recommended the inclusion of rotavirus vaccination in all national immunization programs, and GAVI and other stakeholders are working to make rotavirus vaccines available in the poorest countries of the world.
1 Mast, C. et al, Case-control study of the effectiveness of vaccination with pentavalent rotavirus vaccine in Nicaragua, PIDJ, November 2011, p. e213.
2 K. Zaman et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomized, double-blind, placebo-controlled trial, Lancet, August 2010, p. 615.