March 24, 2010
The Food and Drug Administration (FDA) has temporarily suspended use of the Rotarix vaccine for rotavirus immunization in the United States. An independent research team has found DNA from a porcine circovirus 1 (PCV1) in the vaccine, which is manufactured by GlaxoSmithKline. PCV1 has not been found to cause illness in humans or animals, and there is no evidence at this time that this finding poses a safety risk. The FDA is recommending that practices temporarily suspend the use of Rotarix while further studies are conducted. Providers are advised to retain their current vaccine supplies until the FDA's expert advisory committee makes additional recommendations in four to six weeks on the use of Rotarix. PCV1 has not been detected in RotaTeq, the other rotavirus vaccine, which is manufactured by Merck.

For more information:

CDC Health Alert
FDA News Release
Statement from GlaxoSmithKline
Information for Healthcare Providers and Public Health Professionals