RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P), herein referred to as type P1A, from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain.
02/23/2017 - PDUFA goal date
08/14/2020 - FDA approval date
A Vaccines and Related Biologics Products Advisory Committee meeting was not held for this supplement as there were no issues or concerns that presented during the course of review of the supplement that required consult from the advisory committee.