FDA recommended physicians suspend use of GSK’s Rotarix rotavirus vaccine due to porcine circovirus 1 contamination

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On Mar. 23, 2010, the U.S. Food and Drug Administration (FDA) recommended that physicians temporarily suspend use of GlaxoSmithKline’s Rotarix (rotavirus vaccine, live, oral) because DNA from porcine circovirus 1 (PCV1) was detected in the vaccine.

Rotarix was a two-dose, orally-administered vaccine that offered protection against rotavirus to infants and children. It was discovered that both rotavirus vaccines licensed in the U.S.- Rotarix and RotaTeq- contained PCV type 1.  PCV-1 is a small circular virus composed of a single strand of DNA, but is not known to cause disease in animals or humans.

PCV is common in healthy pigs, and humans are routinely exposed to the virus by eating pork. Safety monitoring of both vaccines has not shown any reason for concern about PCV.

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Source: U.S. Centers for Disease Control and Prevention
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