Distributed via Health Alert Network
Monday, March 22, 2010, 15:54 EDT (03:54 PM EDT)
The U.S. Food and Drug Administration (FDA) has learned that DNA from porcine circovirus type 1 (PCV1), a virus not known to cause disease in humans, is present in the Rotarix vaccine. All available evidence indicates that there has been no increased risk to patients who have received this vaccine. PCV1 is not known to cause any disease in animals or humans; therefore, it has not been routinely tested for in vaccine development. Rotarix has been extensively studied, before and after approval, and found to have an excellent safety record (i.e., no unusual adverse events). However, FDA is recommending that healthcare practitioners temporarily suspend usage of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about the detection of components of the virus found in the vaccine.