GSK’s Rotarix BLA Accepted for Review

The FDA has accepted for review GlaxoSmithKline’s BLA for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain.

The BLA for the rotavirus candidate vaccine includes data from clinical trials conducted in the Americas, Europe, Asia and Africa in nearly 75,000 infants.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination against rotavirus to prevent rotavirus gastroenteritis with the vaccine currently licensed by the FDA at two, four, and six months of age.