FDA Recommends Temporary Suspension of Use of Rotarix

The FDA is recommending that physicians temporarily suspend use of GlaxoSmithKline's Rotarix rotavirus vaccine because DNA from porcine circovirus 1, or PCV1, has been detected in the vaccine. FDA commissioner Margaret Hamburg, M.D., said during a March 22 conference call that PCV1 is not known to cause disease in animals or humans. She said the Rotarix rotavirus vaccine, which was approved in 2008, has an excellent safety record, and the recommendation to suspend its use was made out of an abundance of caution.