Accelerating the development of new rotavirus vaccines
Each year, an estimated 1.8 million children die from severe, dehydrating diarrhea. The most common cause of severe diarrhea—accounting for 2 million hospitalizations and more than 500,000 deaths each year—is rotavirus. Nearly every child in the world, regardless of socioeconomic level or geographic location, will contract rotavirus at least once before the age of three. However, due to limited access to adequate health care, children in the poorest countries consistently account for up to 85 percent of rotavirus deaths.
Rotavirus is highly contagious and resilient, and traditional diarrheal disease prevention measures are not enough to limit its impact. Vaccination is the best hope for protecting infants against severe diarrhea and death from rotavirus infection. Commercial rotavirus vaccines exist and have been demonstrated to be safe and effective in certain populations, but they are not yet widely available or affordable for the developing world. In order to address these gaps, PATH is working on two fronts: to make existing vaccines more available and to accelerate the development of safe, effective, and affordable new vaccines.
Two vaccines against rotavirus are currently in use in several countries in North and Latin America, Europe, and Australia. PATH's Rotavirus Vaccine Trials Partnership is working in partnership with the GAVI Alliance, the World Health Organization (WHO), and the US Centers for Disease Control and Prevention to conduct clinical trials in Africa and Asia to assess the safety and efficacy of both vaccines. Because the performance of oral vaccines like these can vary in different regions and populations, WHO has requested these trials as a prerequisite to recommending global use.
In parallel, PATH is also working with emerging-country manufacturers to develop promising new candidates into safe, effective, and affordable vaccines. Introducing new rotavirus vaccines to the market is key to improving affordability and ensuring a sustainable supply for widespread use in developing countries. PATH collaborates closely with partners on clinical development, formulation, manufacturing, and compliance with national regulatory authorities and WHO to move these new vaccines forward.
New vaccines on the horizon
PATH is supporting the development of three new rotavirus vaccine candidates that could prove both affordable and effective in the developing world.
Since 2001, PATH has been part of a collaborative effort to develop and evaluate the 116E human monovalent vaccine candidate, supporting Bharat Biotech International Ltd. (BBIL) in India to conduct early-stage clinical trials. PATH is also currently supporting BBIL to build manufacturing and quality control systems and prepare for a Phase 3 efficacy trial of 116E.
Seven emerging-country manufacturers and one US company have licensed a second candidate, known as the bovine-human reassortant vaccine (BRV). PATH is directly supporting the development of the BRV by two manufacturers, Shantha Biotechnics Ltd. in India (since 2007) and China National Biotec Group's Wuhan Institute of Biological Products (since 2007), providing financial support and scientific assistance to conduct Phase 1 and 2 clinical trials. PATH also provides a "shared technology platform" for all manufacturers actively developing the BRV to access a host of technologies, training, methodologies, and material.
In 2008, PATH formed a partnership with Murdoch Childrens Research Institute (MCRI) in Australia to support their development of the monovalent RV3 vaccine candidate. PATH is assisting MCRI in the production of RV3 clinical trial lots in preparation for Phase 1 and 2 clinical trials that they will conduct.