FDAnews
www.fdanews.com/articles/84360-fda-approves-rotavirus-vaccine-rotateq-for-infants

FDA APPROVES ROTAVIRUS VACCINE ROTATEQ FOR INFANTS

February 6, 2006

The FDA has approved RotaTeq, a live, oral vaccine intended for use in infants to prevent common and highly contagious rotavirus infections, which cause gastroenteritis, leading to diarrhea, vomiting, fever, and dehydration. The approval came after the agency's Vaccines and Related Biological Products Advisory Committee voted unanimously that the clinical data from a clinical trial supported the safety and efficacy of RotaTeq.

RotaTeq -- a liquid vaccine that is given by mouth between the ages of 6 weeks and 32 weeks -- targets the five strains of rotavirus, namely G1, G2, G3, G4 and P1, which are responsible for more than 90 percent of rotavirus infections around the world.