MONDAY, Feb. 13, 2006 (HealthDay News) -- The U.S. Food and Drug Administration has approved a live, oral vaccine -- called RotaTeq -- to prevent rotavirus gastroenteritis in infants. It's 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 Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research.
Rotavirus infection is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. The U.S. Centers for Disease Control and Prevention estimates that rotavirus infection causes about 55,000 U.S. hospitalizations annually of infants and young children. While death from rotavirus is rare in the United States, in developing countries it is believed to cause up to several hundred thousand deaths each year, the FDA said.
In studies, RotaTeq prevented 74 percent of all rotavirus cases and 98 percent of severe cases. In addition, the vaccine prevented approximately 96 percent of hospitalizations due to infection, the FDA said.
In 1998, the FDA approved a different live vaccine against rotavirus that was later withdrawn from the market because it was linked with an increased risk of intussusception, a rare, life-threatening blockage or twisting of the intestine. Studies of RotaTeq, which is manufactured by Merck & Co., was not associated with an increased risk of the condition, the FDA said.
To learn more about rotavirus, visit the U.S. Centers for Disease Control and Prevention.