The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced a new license agreement aimed at helping to prevent hundreds of thousands of deaths annually from rotavirus diarrhea in children living in developing countries. An effective oral rotavirus vaccine - created by NIAID scientists in the mid- to late 1980s and developed further through a Cooperative Research and Development Agreement with an industry partner - has now been licensed by the NIH Office of Technology Transfer to BIOVIRx, Inc., of Minneapolis, MN. BIOVIRx, which is responsible for obtaining requisite marketing approvals for this product, plans global commercialization of the oral vaccine (RotaShield).

Rotaviruses are consistently shown to be the leading cause of severe diarrhea in infants and young children. Worldwide, the wheel-shaped viruses are estimated to cause more than 135 million episodes of diarrhea each year in infants and children younger than 5 years old, resulting in up to 592,000 deaths annually.

Rotaviruses are egalitarian viruses: they readily infect and cause illness in infants and young children in both developed and developing countries. The overall consequences of these illnesses, however, are quite different. Approximately 1,600 rotavirus-related deaths each day occur predominantly in the developing countries, notes Albert Z. Kapikian, M.D., who led the NIAID team that developed the vaccine and serves as head of the epidemiology section in the Institute's Laboratory of Infectious Diseases.

Symptoms of rotavirus infection develop quickly and in addition to diarrhea, may include vomiting, fever and dehydration. The resulting dehydration can be reversed through oral rehydration therapy or, in more serious cases, through hospitalization and intravenous fluids. Although effective, these therapies are not readily available or used in many parts of the developing world. Children in developing countries are more vulnerable to severe and fatal illness.

Dr. Kapikian has devoted most of his career to working on viruses that cause gastroenteritis. He and his colleagues discovered the Norwalk virus, the first virus to be established as an important cause of diarrhea. Later, he and his colleagues in NIAID developed the rotavirus vaccine that was tested in the United States and abroad in collaborative studies.