Abstract
This report describes FDA's laboratory response to the 2010 reports that porcine circovirus type 1 (PCV-1) DNA was present in U.S.-licensed rotavirus vaccines and in cells used to produce inactivated poliovirus vaccines. In the present study, Rotarix® (GlaxoSmithKline, Rixenxart, Belgium) was found to contain full-length PCV-1 genomes that are particle-associated, and cell culture assays in swine testis (ST) and PCV-free porcine kidney (PK-15) cells confirmed that PCV-1 sequences in this vaccine represent infectious virus. RotaTeq® (Merck and Co., West Point, PA, USA) contained small PCV-1 and PCV-2 genome fragments, but did not contain detectable larger portions of (or full-length) PCV genomes, and cell culture assays did not amplify PCV from this vaccine. Inactivated poliovirus vaccine bulks (GlaxoSmithKline) were also negative for the presence of PCV by cell culture infectivity assay. In these vaccines, molecular characterization of PCV nucleic acids was useful for predicting the results of cell culture assays.
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