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The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The World Health Organization (WHO) has recommended that health authorities in all nations routinely vaccinate young children against rotavirus, which causes 2 million hospitalizations and 500,000 deaths from severe diarrhoeal dehydration every year. Rotavirus vaccines are already recommended for use in the Americas and Europe. But more than 85% of deaths caused by rotavirus occur in developing countries in Asia and Africa, says the WHO. The recommendation was made by the WHO's Strategic Advisory Group of Experts, which reviewed a clinical trial of GlaxoSmithKline's Rotarix vaccine in South Africa and Malawi that cut the occurrence of severe diarrhoeal episodes. RotaTeq,...

A vaccine against rotavirus, the leading cause of diarrhea in infants, has led to a dramatic drop in hospitalization and emergency room visits since it came on the market two years ago, doctors reported Saturday. A bonus: the vaccine seems to be preventing illness even in unvaccinated children by cutting the number of infections in the community that kids can pick up and spread. "We're a little surprised by the degree of impact given the coverage we've achieved," said Jane Seward of the federal Centers for Disease Control and Prevention. Only about half of young children had received the vaccine...

FOR IMMEDIATE RELEASE P06-16 Media Inquiries: Stephen King, 301-827-6242 Consumer Inquiries: 888-INFO-FDA The Food and Drug Administration (FDA) today announced the approval of RotaTeq™, a live, oral, vaccine for use in preventing rotavirus gastroenteritis in infants. It is the only vaccine approved in the United States that can help protect against rotavirus, a viral infection that may cause diarrhea, vomiting, fever, and dehydration. "This vaccine gives health care providers an important new tool that can effectively prevent an illness that affects almost all children within the first few years of life," said Jesse L. Goodman, MD, MPH, director of FDA’s...