FDA recommends temporary suspension of Rotarix vaccine use

The FDA is recommending healthcare practitioners temporarily suspend the use of Rotarix (live, attenuated human G1P[8] rotavirus vaccine, from GlaxoSmithKline) for rotavirus immunization while it learns more about components of an extraneous virus detected in the vaccine. The FDA recently became aware that an independent academic research team has found DNA from porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals. There is no evidence at this time that this finding poses a safety risk.

The FDA will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present.  The agency is assessing current vaccine testing methods.  In 4–6 weeks, the FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm.