What is FDA announcing?
FDA is announcing the approval of RotaTeq, a new vaccine for the prevention of rotavirus gastroenteritis in infants. RotaTeq is the only US licensed vaccine that effectively prevents a viral infection, called rotavirus that may cause diarrhea, vomiting, fever and dehydration. • What is rotavirus and how commonly does it occur? Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. In the United States, the disease occurs more often during the winter, with the most activity occurring from November to May. Most children, whether in the US or elsewhere, are infected with rotavirus before they are two years old. Sometimes diarrhea and vomiting due to rotavirus infection can lead to the loss of body fluids (dehydration) which in some instances may be severe enough to require hospitalization. In the United States, rotavirus infection causes an estimated 55,000 hospitalizations a year of infants and young children, alth