GlaxoSmithKline received approval from the FDA for its Rotarix vaccine for the prevention of rotavirus gastroenteritis in infants. With two doses, Rotarix offers protection against the most common rotavirus types in the U.S. and allows infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Rotavirus infects virtually every child in the U.S. by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide.
   
Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data of Rotarix show that protection was sustained through the first two years of life and was highly effective against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). Rotarix was also effective against rotavirus gastroenteritis of any severity (79%).
   
AVANT Immunotherapeutics, Inc. licensed the technology for Rotarix to GSK in 1997 for worldwide commercialization. The approval was based on one of the largest clinical development programs undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa.