Rotavirus Vaccine Project
In general, vaccines licensed for use in industrialized countries have taken more than a decade to reach developing countries. PATH’s Rotavirus Vaccine Program (RVP), established in 2003, set out to accelerate the licensing and availability of rotavirus vaccines in the developing world and reduce the enormous time lag. RVP generated and disseminated information on the worldwide burden of rotavirus disease, vaccine efficacy and safety in developing countries, and the value and cost-effectiveness of rotavirus vaccines.
RVP, a partnership between PATH, the CDC, and the WHO was funded by the GAVI Alliance (GAVI) until 2011. Remarkably, due in large part to work conducted by PATH and partners under RVP and with a donation of vaccine from Merck & Co., Inc., an infant girl in Nicaragua became the first in her country to be vaccinated against rotavirus just a few months after the vaccine was introduced in the United States. This marked the first time a new vaccine reached a developing country in the same year it became available in an industrialized country.
RVP’s support of rotavirus vaccine clinical trials in the developing world began in 2004, building off the foundation laid by the Rotavirus Action Program for Immunization and Development (RAPID), a public-private partnership involving RVP partners WHO and PATH, that initiated Phase I and II trials in South Africa and Bangladesh. RVP continued its support of rotavirus clinical trials by collaborating with vaccine manufacturers to conduct Phase 3 clinical trials in Africa and Asia, to establish proof of efficacy of rotavirus vaccines in those populations. On the basis of efficacy data from Europe and America, the WHO initially approved use of the vaccines in these regions in 2006. Subsequently, after proof of efficacy in Asia and Africa in 2009, the WHO recommended that rotavirus vaccines be introduced into every country’s national immunization program, particularly in countries where diarrheal disease is a major health problem.