Advancing new rotavirus vaccines

Each year, an estimated 1.6 million children die from severe, dehydrating diarrhea and millions more are hospitalized. 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 will contract rotavirus at least once before three years of age. However, because of limited access to health care, children in the poorest countries consistently account for more than 90 percent of rotavirus deaths.

Rotavirus is highly contagious and resilient, and traditional diarrheal disease prevention measures are not enough. Prevention by vaccination is the best hope for protecting infants against severe diarrhea and death from rotavirus infection. Rotavirus vaccines already exist and have been demonstrated to be safe and effective in certain populations. Unfortunately, they are not yet widely available in the developing world. In order to address this gap, PATH is working on two fronts: to make existing vaccines more available and to accelerate the development of new vaccines.

Two vaccines against rotavirus are currently licensed and in use in several countries in North and Latin America and Europe. PATH’s Rotavirus Vaccine Program is working in partnership with the GAVI Alliance, the World Health Organization (WHO), and the US Centers for Disease Control and Prevention to help countries access and afford the licensed vaccines. PATH is also collaborating with the vaccine manufacturers to conduct clinical trials in Africa and Asia to assess the safety and efficacy of these vaccines. Because the performance of oral vaccines like these can vary in different regions, WHO has requested these trials as a prerequisite to recommending global use.

In parallel, PATH’s Advancing Rotavirus Vaccine Development project is working with emerging manufacturers to develop promising new candidates into safe, effective, and affordable vaccines. Introducing new vaccines to the market is a 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 new vaccines forward.

New vaccines on the horizon

Two new vaccines are in development that could prove both affordable and effective in the developing world. One is the 116E human monovalent vaccine, which is being developed by the Indian manufacturer Bharat Biotech International, Ltd. (BBIL). Seven emerging-country manufacturers and one US company are developing a second candidate, known as the human bovine reassortant vaccine. This vaccine, containing components developed by the US National Institutes of Health, contains the four most common rotavirus strains in addition to strains that have emerged more recently in Asia and Africa. These two candidates have the potential to provide lower-cost rotavirus vaccines for wide use in low-resource countries.

Building capacity worldwide

Since 2001, PATH has been part of a collaborative effort to develop and evaluate the 116E vaccine, and is currently supporting BBIL to build manufacturing and quality control systems, as well as conduct early-stage clinical trials. PATH also provides a “shared technology platform” for manufacturers of the human bovine reassortant vaccine to access a host of technologies, training, and common technical support to help maximize the production capacity and global availability of this rotavirus vaccine. In addition, PATH is supporting the development of this vaccine by two manufacturers in particular, Shantha Biotech in India and China National Biotec Group’s Wuhan Institute of Biological Products, providing financial support and scientific assistance.