New Rotavirus Vaccines Safe and Effective in Large Clinical Trials

The January 5 issue of The New England Journal of Medicine carries reports of 2 large clinical trials of promising new oral vaccines for rotavirus, the leading recognized cause of diarrhea-related illness and death among infants and young children. Every year, rotavirus is associated with 25 million clinic visits, 2 million hospitalizations, and more than 600,000 deaths worldwide among children younger than 5 years of age. Development of a safe and effective rotavirus vaccine has become a high priority, particularly but not exclusively in developing countries, where the burden of disease is highest. A tetravalent rhesus–human reassortant vaccine was withdrawn from the market due to an association with intussusception, prolapse of a portion of the intestine within another immediately adjacent portion of intestine. Thus, ruling out such a risk has become critical for the licensure and universal use of any new rotavirus vaccine.