On March 22, 2010, the FDA announced that an independent U.S. academic research team had found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA recommended that healthcare practitioners suspend use of ROTARIX vaccine in the U.S. while the agency learned more about PCV1. They did, however, report that this finding posed no safety concerns and stated that PCV1 was not known to cause illness in humans or other animals.
On May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2. Although PCV1 had not been associated with clinical disease in pigs, PCV2 was known to be a lethal pig virus that caused immune suppression and a serious wasting disease in baby pigs that damages lungs, kidneys, the reproductive system, brain and ultimately causes death. The FDA recommended temporary suspension of the use of ROTARIX vaccine on March 22, 2010 after DNA from PCV1 was identified in ROTARIX but did not call for suspension of the use of RotaTeq vaccine after PCV2 was found in RotaTeq.
However, one week later, on May 14, 2010, the FDA announced that they had reviewed the scientific evidence and determined that the vaccine was safe and use of the product should continue. PCV1 remains a contaminant of the ROTARIX vaccine and PCV1 and PCV2 continue to contaminate RotaTeq vaccines.
