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Proper Name
Rotavirus Vaccine, Live, Oral
For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.

ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.

Key Regulatory Milestones

06/04/2007 - The Biologics License Application (BLA) for Rotavirus Vaccine, Live, Oral (ROTARIX®) from GlaxoSmithKline Biologicals (GSK) was received by CBER.

06/2000 - GSK had filed an Investigational New Drug Application (IND) under which an initial Phase 2 study had been conducted in the U.S.

09/2006 - Pre-BLA meeting was held.

04/03/2008 - PDUFA Goal Date

11/12/2019 - FDA approval date

Advisory Committee

The Vaccines and Related Biological Products Advisory Committee meeting took place on February 20, 2008. The committee voted unanimously regarding the adequacy of the efficacy of the vaccine and all except one member voted in favor of the adequacy of the safety data to support the licensure of ROTARIX.

Advanced Facts