Rotavirus is the single most important cause of severe diarrhea among children throughout the world, and it is responsible for millions of hospitalizations and an estimated 527,000 deaths per year, with 85% of these deaths occurring in developing countries.

While live oral rotavirus vaccines have demonstrated good efficacy against severe rotavirus diarrhea in clinical trials conducted in the Americas and Europe, data on the efficacy in developing countries has raised concern about efficacy in resource-limited settings, where an effective vaccine is needed most.

Over the past decade, Centers for Disease Control and Prevention (CDC) scientists have been conducting research and development on an inactivated rotavirus vaccine as an alternative to the live oral rotavirus vaccines. To produce an inactivated rotavirus vaccine, CDC entered into a Cooperative Research and Development Agreement (CRADA) with Sanofi Pasteur.

With rotavirus the primary cause of severe diarrhea among children throughout the world, this vaccine will substantially reduce the millions of hospitalizations and the estimated 527,000 deaths per year due to rotavirus infections.

Under this successful collaboration, CDC scientists identified new and improved methods to inactivate rotavirus. This novel approach used heat inactivation instead of the more common chemical inactivation methods. Compared to chemical methods, the CDC method is rapid, simple, maintains the integrity of the virus particles, and preserves their antigenicity.

Over the past few years, CDC has entered into patent license agreements with five Chinese vaccine manufacturers (two evaluation licenses and three full commercial licenses), one Indian vaccine manufacturer, and one company in Vietnam. In addition, CDC has signed evaluation agreements with three domestic companies to evaluate CDC’s technology as part of their potential vaccine pipelines.

Through the continued efforts of CDC laboratory scientists, technology transfer professionals and private sector partners, this inactivated rotavirus vaccine will alleviate the morbidity and mortality associated with rotavirus. With rotavirus the primary cause of severe diarrhea among children throughout the world, this vaccine will substantially reduce the millions of hospitalizations and the estimated 527,000 deaths per year due to rotavirus infections.